Name | Unique ID | Edition | Date of Edition |
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Quality Manual | LSSTH/A/Central/P/8.3/1 | 1 | 01-03-2023 |
Preparing authority | Approving authority | Review period | Review Date |
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All teaching staff | Quality Manager | 2 year |
Printed copy of this document is considered uncontrolled. It should be compared with controlled electronic copy before use |
Sr. No | Date of Amendment | Page & Clause Number of Amendment | Amendment detail | Reason for Amendment |
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1 |
Medical laboratories — Requirements for quality and competence
The Laboratory Services Sir T Hospital (LSSTH) is a part of Sir T General Hospital and Government Medical College, Bhavnagar. Both the institutions come under the Department of Health & Family Welfare, Government of Gujarat, Gandhinagar. The Laboratory Services Sir T Hospital offers investigation facilities through section of the Biochemistry, Microbiology, Pathology of Medical College, Bhavnagar. These sections carry out investigations pertaining to Clinical Biochemistry, Microbiology, Serology, Clinical Pathology, Hematology, Histopathology and Cytopathology. The services are provided to the patients coming to Sir T Hospital, Bhavnagar. The Laboratory meets all the requirements of international standard ISO 15189: 2022 , updated NABL-112 and in addition to this Laboratory also follows national, regional and local regulations wherever applicable.
Laboratory Services Sir T Hospital, Bhavnagar provides services for the patients of Sir T Hospital, Bhavnagar which is tertiary care hospital attached with Government Medical College Bhavnagar, established by Government of Gujarat, India. Medical Superintendent, Sir T Hospital, Bhavnagar directs entire laboratory services. Various resources required for laboratory services are provided by Sir T Hospital, Bhavnagar as well as Government Medical College Bhavnagar.
Laboratory Services Sir T Hospital(LSSTH), Bhavnagar is operated under three departments.
The scope of the accreditation will be applicable to the following medical laboratory services.
Laboratory Services Sir T Hospital, Bhavnagar has developed and implemented a Quality manual for that Laboratory has follow the following guidelines.
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
- ISO Online browsing platform: available at https: www .iso .org/ obp - IEC Electropedia: available at https: www .electropedia .org/
Measurement bias is estimate of a systematic measurement error.
Note 1 to entry: This definition only applies to quantitative measurements
[SOURCE: ISO/IEC Guide 99:2007, 2.18, modified — Note 1 to entry has been added.]
Reference interval is a specified interval of the distribution of values taken from a biological reference population.
Note 1 to entry: A reference interval is commonly defined as the central 95% interval. Another size or an asymmetrical location of the reference interval could be more appropriate in particular cases.
Note 2 to entry: A reference interval can depend upon the type of primary sample (3.25) and the examination procedure (3.9) used.
Note 3 to entry: In some cases, only one biological reference limit is important, usually an upper limit, “x”, so that the corresponding biological reference interval would be less than or equal to “x”.
Note 4 to entry: Terms such as ‘normal range’, ‘normal values’, and ‘clinical range’ are ambiguous and therefore discouraged.
[SOURCE: ISO 18113-1:2022, 3.1.9, modified — The EXAMPLE has been removed.]
Examination (3.8) result that indicates a higher risk of adverse clinical outcomes, or is diagnostic for the presence of a specifc disease.
Note 1 to entry: Clinical decision limits for therapeutic drugs are called “therapeutic range”.
Note 2 to entry: It is used to determine risk of disease, to diagnose or to treat.
Commutability is a property of a reference material, demonstrated by the closeness of agreement between the relation among the measurement results for a stated quantity in this material, obtained according to two given measurement procedures and the relation obtained among the measurement results for other specified materials.
Note 1 to entry: The reference material in question is usually a calibrator and the other specified materials are usually routine samples.
Note 2 to entry: It is typical that there are more than two measurement procedures available and comparison among all applicable measurement procedures is desirable.
Note 3 to entry: Closeness of agreement of measurement results is defined in terms of fitness for purpose as appropriate for the intended use of the reference material.
Note 4 to entry: A commutability statement is restricted to the measurement procedures as specified in a particular comparison.
[SOURCE: ISO 17511:2020 3.10, modified — Note 2 to entry has been replaced by a new Note 2 to entry.]
It is a demonstrated ability to apply knowledge and skills to achieve intended results.
[SOURCE: ISO/IEC 17021-1:2015, 3.7, modified — “demonstrated” added to the beginning of the definition.]
Expression of dissatisfaction by any person or organization to a laboratory (3.20), relating to the activities or results of that laboratory, where a response is expected.
[SOURCE: ISO/IEC 17000:2020, 8.7, modified — The words “other than appeal” have been deleted, and the words “a conformity assessment body or accreditation body, relating to the activities of that body” have been replaced by “a laboratory, relating to the activities or results of that laboratory”.]
Person who provides expert advice professionally.
Set of operations having the objective of determining the numerical value, text value or characteristics of a property.
Note 1 to entry: An examination may be the total of a number of activities, observations or measurements required to determine a value or characteristic.
Note 2 to entry: Laboratory examinations that determine a numerical value of a property are called “quantitative examinations”; those that determine the characteristics of a property are called “qualitative examinations”.
Note 3 to entry: Laboratory examinations are also called “assays” or “tests”.
Specifically described set of operations used in the performance of an examination (3.8) according to a given method.
Note 1 to entry: In the IVD medical device industry and in many laboratories that use IVD medical devices, an examination procedure for an analyte in a biological sample is commonly referred to as an analytical method, analytical procedure or test procedure.
[SOURCE: ISO 15198:2004, 3.7, modified — “set of operations described specifically” changed to “specifically described set of operations”.]
EQA evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons
Note 1 to entry: Also known as proficiency testing (PT)
[SOURCE: ISO/IEC 17043:2010, 3.7 modified — The term “external quality assessment”, which was given in Note 2 to entry, is used as the main term. Notes to entry 1 and 2 have been omitted and a new Note 1 to entry added.]
Objectivity with regard to the outcome of tasks performed by the medical laboratory (3.20).
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.
Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.
[SOURCE: ISO/IEC 17000:2020 5.3 modified — “outcome of a conformity assessment activity” has been changed to “tasks performed by the medical laboratory”. Note 2 to entry has been added.]
Organization, performance and evaluation of measurements or examinations (3.8) on the same or similar materials by two or more independent laboratories in accordance with pre-determined conditions.
[SOURCE: ISO/IEC 17043:2010 3.4, modified — “tests” has been replaced by “examinations”. “items” has been replaced by “materials”. “laboratories” has been replaced by “independent laboratories”.]
Quality control(QC) - Internal procedure which monitors the testing process to verify the system is working correctly and gives confidence that the results are reliable enough to be released.
[SOURCE: ISO/TS 22583:2019 3.9, modified — “decide” has been replaced by “verify”. Note 1 to entry has been removed. ]
IVD medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.
[SOURCE: ISO 18113-1:2022, 3.1.33, modified — “medical” has been removed from the beginning of the definition. “and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles” has been added to the end of the definition. Notes 1 and 2 to entry have been removed.]
Person(s) with responsibility for, and authority over a laboratory (3.20).
Note 1 to entry: Laboratory management has the power to delegate authority and provide resources within the laboratory.
Note 2 to entry: The laboratory management includes the laboratory director(s) and delegates together with individuals specifically assigned to ensure the quality of the activities of the laboratory.
Individual or entity requesting services of the medical laboratory (3.20).
Note 1 to entry: Users can include patients, clinicians, and, other laboratories or institutions that send samples for examination.
Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.
Note 1 to entry: This was formerly referred to and is synonymous with “quality management system”.
Note 2 to entry: The management system elements establish the organization’s structure, roles and responsibilities, planning, operation, policies, practices, rules, beliefs, objectives, and processes to achieve those objectives.
[SOURCE: ISO 9000:2015, 3.5.3 modified — Notes to entry 1, 3 and 4 have been removed and a new Note 1 to entry has been added.]
Accuracy of measurement is closeness of agreement between a measured quantity value and a true quantity value of a measurand.
Note 1 to entry: The concept ‘measurement accuracy’ is not a quantity and is not given a numerical quantity value. A measurement is said to be more accurate when it offers a smaller measurement error.
Note 2 to entry: The term “measurement accuracy” should not be used for measurement trueness and the term measurement precision should not be used for ‘measurement accuracy’, which, however, is related to both these concepts.
Note 3 to entry: ‘Measurement accuracy’ is sometimes understood as closeness of agreement between measured quantity values that are being attributed to the measurand.
[SOURCE: ISO/IEC Guide 99:2007, 2.13]
3.19 Measurement uncertainty - MU
Non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used
Note 1 to entry: MU includes components arising from systematic effects, as in the case of corrections to the assigned quantity values of measurement standards. Sometimes estimated systematic effects are not corrected for, but instead, the associated MU components are incorporated.
Note 2 to entry: The parameter may be, for example, a standard deviation (SD) called standard MU (or a specified multiple of it), or the half-width of an interval, having a stated coverage probability.
Note 3 to entry: MU comprises, in general, of many components. Some of these may be evaluated by Type A evaluation of MU from the statistical distribution of the quantity values from series of measurements and can be characterized by SD. The other components, which may be evaluated by Type B evaluation of MU, can also be characterized by SD or evaluated from probability density functions based on experience or other information.
Note 4 to entry: In general, for a given set of information, it is understood that the MU is associated with a stated quantity value attributed to the measurand. A modification of this value may result in a modification of the associated uncertainty.
Note 5 to entry: All measurements have bias (3.1) and imprecision. For example, replicate measurements of a sample performed under repeatability conditions generally produce different values for the same measurand. Because the different values could all be reasonably attributed to the same amount of measurand, there is uncertainty as to which value should be reported as the value of the measurand.
Note 6 to entry: Based on available data about the analytical performance of a given measurement procedure, an estimation of MU provides an interval of values that is believed to include the actual value of the measurand, with a stated level of confidence.
Note 7 to entry: Available data about the analytical performance of a given measurement procedure typically comprise uncertainty of calibrator assigned values and long-term imprecision of IQC materials.
Note 8 to entry: In medical laboratories, most measurements are performed in singleton, and are taken to be an acceptable estimate of the value of the measurand, while the MU interval indicates other results that are also possible.
[SOURCE: ISO/IEC Guide 99:2007 2.26, modified — Notes to entry 5 to 8 have been added from ISO/TS 20914:2019 3.26.]
Laboratory entity for the examination (3.8) of materials derived from the human body for the purpose of providing information for the diagnosis, monitoring, management, prevention and treatment of disease, or assessment of health.
Note 1 to entry: The laboratory can also provide advice covering all aspects of examinations including appropriate selection, the interpretation of results and advice on further examinations.
Note 2 to entry: Laboratory activities include pre-examination (3.24), examination (3.8) and post-examination processes (3.23).
Note 3 to entry: Materials for examination (3.8) include but are not limited to, microbiological, immunological, biochemical, immunohaematological, haematological, biophysical, cytological, tissue and cells, and genetic material.
Person who is the source of material for an examination (3.8).
POCT examination (3.8) performed near or at the site of a patient (3.21).
[SOURCE: ISO/TS 22583:2019, 3.11]
Processes following the examination (3.8) including review of results, formatting, releasing, reporting and retention of examination results, retention and storage of clinical material, sample (3.28) and waste disposal.
Processes that start, in chronological order, from the user’s request and include the examination (3.8) request, preparation and identification of the patient (3.21), collection of the primary sample(s) (3.25), transportation to and within the laboratory (3.20), ending when the examination (3.8) begins.
Specimen discrete portion of a body fluid or tissue or other sample associated with the human body taken for examination (3.8), study or analysis of one or more quantities or characteristics to determine the character of the whole.
Note 1 to entry: The International Medical Device Regulators Forum (IMDRF) uses the term specimen in its harmonized guidance documents to mean a sample of biological origin intended for examination by a medical laboratory (3.20).
[SOURCE: ISO 18113-1:2022, 3.1.65, modified — Note 1 to entry has been modified. Note 2 to entry has been deleted.]
Measure of the degree to which a large number of characteristics of an object fulfils requirements.
Note 1 to entry: Measure can be expressed, for example, as % yield (% within specified requirements), % defects (% outside specified requirements), defects per million occasions (DPMO) or on the Six Sigma scale.
Note 2 to entry: Quality indicators can measure how well an organization meets the needs and requirements of users and the quality of all operational processes.
External laboratory (3.20) to which a sample or data is submitted for examination (3.8).
Note 1 to entry: A referral laboratory is one to which laboratory management chooses to submit a sample or sub-sample for examination, data for analysis or interpretation, or when routine examinations cannot be carried out.
Note 2 to entry: This differs from a laboratory to which submission of samples is required by regulation, or a so called reference laboratory, e.g. public health, forensic, tumour registry, or a central (parent) facility to which submission of samples is required by structure.
One or more parts taken from a primary sample (3.25).
Measurement trueness is a closeness of agreement between the average of an infinite number of replicate measured quantity values and a reference quantity value.
Note 1 to entry: Measurement trueness is not a quantity and thus cannot be expressed numerically, but measures for closeness of agreement are given in ISO 5725-1.
Note 2 to entry: Measurement trueness is inversely related to systematic measurement error, but is not related to random measurement error.
Note 3 to entry: ‘Measurement accuracy” should not be used for ‘measurement trueness’.
Note 4 to entry: For qualitative examinations, trueness of measurement (closeness of agreement) can be expressed in terms of concordance (i.e. percent agreement with a reference examination).
Note 5 to entry: Trueness is a property of the examination procedure (3.9) that reflects the bias (3.1) of the measurements from the expected or target value. It is described qualitatively as good or bad. An examination procedure (3.9) has good trueness if the bias (3.1) of the measurements is acceptable.
[SOURCE: ISO/IEC Guide 99:2007, 2.14, modified — Notes to entry 4 and 5 have been added.]
Elapsed time between two specified points through pre-examination (3.24), examination (3.8), and post-examination processes (3.23).
Confirmation of plausibility for a specific intended use or application through the provision of objective evidence that specified requirements have been fulfilled.
Note 1 to entry: Objective evidence can be obtained through observation, measurement, examination or by other means.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: Specified requirements of an examination method may include the following performance specifications: measurement trueness, measurement precision including measurement repeatability, and measurement intermediate precision, analytical specificity, including interfering substances, detection limit and quantitation limit, measuring interval, clinical relevance, diagnostic specificity and diagnostic sensitivity.
Confirmation of truthfulness, through the provision of objective evidence that specified requirements have been fulfilled.
EXAMPLE 1 Confirmation that performance specifications of a measuring system are achieved.
EXAMPLE 2 Confirmation that a target measurement uncertainty can be met.
Note 1 to entry: Verification is the process by which the laboratory confirms that the established performance claims of a measuring system, e.g. trueness, precision, reportable range, can be replicated in the laboratory before human sample examination is performed.
Note 2 to entry: The objective evidence needed for a verification can be the results of an inspection, or other forms of determination, such as performing alternative calculations or reviewing documents.
Note 3 to entry: Verification may be sufficient to implement a new IVD device under circumstances where the examination (3.8) is performed and used in the manner as directed in the package insert.
Note 4 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO/IEC 17000:2020, 6.6 modified — EXAMPLES 1 and 2 have been added. Notes to entry 1 to 4 have been added.]
NOTE: A relationship that threatens the impartiality of the laboratory can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new laboratory users, etc. Such relationships do not necessarily present
Laboratory will implement & monitor impartiality by following methods.
The laboratory will be responsible, through legally enforceable agreements, for the management of all patient information obtained or created during the performance of laboratory activities. Management of patient information will include privacy and confidentiality. The laboratory will inform the user and/or the patient in advance, of the information it intends to place in the public domain. Except for information that the user and/or the patient makes publicly available, or when agreed between the laboratory and the patient (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and will be regarded as confidential.
The staff are aware of the need to ensure that Impartiality & confidentiality of information is maintained at all times in accordance with the Lab policy and the staff have signed the Declaration of Impartiality & Confidentiality. DECLARATION FOR CONFIDENTIALITY & IMPARTIALITY .
When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the patient concerned will be notified of the information released, unless prohibited by law. Information about the patient from a source other than the patient (e.g. complainant, regulator) will be kept confidential by the laboratory. The identity of the source will be kept confidential by the laboratory and will not be shared with the patient, unless agreed by the source.
Personnel, including any committee members, contractors, personnel of external bodies, or individuals with access to laboratory information acting on the laboratory’s behalf, will keep confidential all information obtained or created during the performance of laboratory activities.
Laboratory management will ensure that patients’ well-being, safety and rights are the primary considerations. The laboratory will establish and implement the following processes:
Government Medical College, Bhavnagar is a teaching institute for medical & paramedical professionals with attached tertiary care center, Sir T Hospital,Bhavnagar, established by Health & Family Welfare Department,Government of Gujarat, India. The laboratory-LSSTH(Laboratory Services Sir T Hospital)is part of the government medical college & Sir T Hospital Bhavnagar. LSSTH laboratory is legally responsible for its activities. LSSTH laboratory providing services to all the patients coming to Sir T Hospital,Bhavnagar at free of cost.
The LSSTH, Bhavnagar is an entity that can be held legally responsible for its activities.
Resolution No: MCG_1095_3377_J Sachivalaya, Gandhinagar dated July 28th, 1995 Legal entity
NOTE: For the purposes of this document, a government laboratory is deemed to be a legal entity on the basis of its government status.
The laboratory is directed by a Dr. Hariom Sharma with the specified qualifications, competence, delegated authority, responsibility, and resources to fulfill the requirements of this document.Appointment order of Laboratory Director PENDING
The laboratory director is responsible for the implementation of the management system, including the application of risk management to all aspects of the laboratory operations so that risks to patient care and opportunities to improve are systematically identified and addressed. The duties and responsibilities of the laboratory director will be documented.
The laboratory director has delegated either selected duties or responsibilities, or both, to qualified and competent personnel - quality manager and such delegation is documented. However, the laboratory director has maintained the ultimate responsibility for the overall operation of the laboratory.
The laboratory will specify and document the range of laboratory activitiesLaboratory Scope, including laboratory activities performed at sites other than the main location (e.g. POCT, sample collection) for which it conforms with this document. The laboratory will only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis.
Laboratory activities will be carried out in such a way as to meet the requirements of this document, the users, regulatory authorities and organizations providing recognition. This applies to the complete range of specified and documented laboratory activities, regardless of where the service is provided.
Laboratory management will ensure that appropriate laboratory advice and interpretation are available and meet the needs of patients and users. The laboratory will The laboratory will communicate via phone calls to treating physician on the following when applicable:
Laboratory Services Sir T Hospital(LSSTH), Bhavnagar is operated under three departments. Department of Biochemistry Department of Microbiology Department of Pathology All three departments have following staff in descending authority of control
In addition, departments may have other personnel (for example, research assistants) who may be working under any other person assigned by Head of the Department. Responsibilities and authorities are defined by Head of the Department in accordance with various instructions provided by Government of Gujarat.
The laboratory will:
The laboratory will have personnel as Quality Manager ,who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including:
NOTE: These responsibilities can be assigned to one or more persons.
1) Laboratory management will establish and maintain objectives and policies to: Quality policy, Objectives & Indicators
2) Laboratory management will ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented.
3) The laboratory will establish quality indicators to evaluate performance throughout key aspects of pre-examination, examination, and post-examination processes and monitor performance in relation to objectives. Quality Indicators
NOTE: Types of quality indicators include the number of unacceptable samples relative to the number received, the number of errors at either registration or sample receipt, or both, the number of corrected reports, the rate of achievement of specified turnaround times.
NOTE 1: ISO 22367 provides details for managing risk in medical laboratories.
NOTE 2: ISO 35001 provides details for laboratory bio risk management.
The laboratory will have available the personnel, facilities, equipment, reagents, consumables and support services necessary to manage and perform its activities.
1. The laboratory will have access to a sufficient number of competent persons to perform its activities. Biochemistry Staff list Appointment Order of all staff Educational Qualifications of all staff Employee's Personal Details Format for Employee's Personal Profile
2. All personnel of the laboratory, either internal or external, that could influence the laboratory activities shall act impartially, ethically, be competent and work in accordance with the laboratory’s management system.
NOTE: ISO/TS 22583 provides guidance for supervisors and operators of POCT equipment.
3. The laboratory will communicate to laboratory personnel the importance of meeting the needs and requirements of users as well as the requirements of this document.
4. The laboratory has a programme to introduce personnel to the organization, the department or area in which the person will work, the terms and conditions of employment, staff facilities, health and safety requirements, and occupational health services.Format for Induction training Record of induction training of new staff
The Laboratory is doing competence assessment by combination of following methods :
The laboratory will authorize personnel to perform specific laboratory activities , including but not limited to, the following:
A continuing education programme will be available to personnel who participate in managerial and technical processes. All personnel will participate in continuing education and regular professional development, or other professional liaison activities. The suitability of the programme and activities will be periodically reviewed.Record of Continuing education & Professional development
The laboratory has procedures and retain records for:
The facilities and environmental conditions will be suitable for the laboratory activities and will not adversely affect the validity of results, or the safety of patients, visitors, laboratory users, and personnel. This will include pre-examination related facilities and sites other than the main laboratory premises where examinations are performed, as well as POCT.
The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities will be specified, monitored, and recorded. Facility and environment control record
NOTE 1: ISO 15190 provides details for facility and environmental conditions.
NOTE 2: Environmental conditions that can adversely affect the validity of results include, but are not limited to: adventitious amplified nucleic acid, microbial contamination, dust, electromagnetic disturbances, radiation, lighting conditions (illumination), humidity, electrical supply, temperature, sound and vibration.
Facility controls will be implemented, recorded, monitored, periodically reviewed, and will include:
There will be adequate access to toilet facilities and a supply of drinking water, as well as facilities for storage of personal protective equipment and clothing. Space for personnel activities, such as meetings, quiet study and a rest area, should be provided.
Sample collection facilities shall:
NOTE: ISO 20658 provides details for sample collection facilities
The laboratory has processes for the selection, procurement, installation, acceptance testing (including acceptability criteria), handling, transport, storage, use, maintenance, and decommissioning of equipment, in order to ensure proper functioning and to prevent contamination or deterioration. Process for selection, procurement, installation, acceptance testing, handling, transport, storage, use, maintenance, and decommissioning of equipment
NOTE: Laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems, or any equipment that influences the results of laboratory activities, including sample transportation systems.
The laboratory will verify that the equipment conforms to specified acceptability criteria before being placed or returned into service. Equipment used for measurement will be capable of achieving either the measurement accuracy or measurement uncertainty, or both, required to provide a valid result.
NOTE 1: This includes equipment used in the laboratory, equipment on loan, or equipment used in point of care settings, or in associated or mobile facilities, authorized by the laboratory.
NOTE 2: The verification of equipment acceptance testing can be, where relevant, based on the calibration certificate of the returned equipment.
Adverse incidents and accidents that can be attributed directly to specific equipment will be investigated and reported to either the manufacturer or supplier, or both, and appropriate authorities, as required. The laboratory will have procedures for responding to any manufacturer's recall or other notice, and taking actions recommended by the manufacturer. Documentary procedures for responding to any manufacturer's recall or other notice
Equipment Records will be maintained for each item of equipment that influences the results of laboratory activities. These records will include the following, where relevant:
The laboratory will specify calibration and traceability requirements that are sufficient to maintain consistent reporting of examination results. For quantitative methods of a measured analyte, specifications will include calibration and metrological traceability requirements. Qualitative methods and quantitative methods that measure characteristics rather than discrete analytes will specify the characteristic being assessed and such requirements necessary for reproducibility over time.
NOTE: Examples of qualitative methods and quantitative methods that may not allow metrological traceability include red cell antibody detection, antibiotic sensitivity assessment, genetic testing, erythrocyte sedimentation rate, flow cytometry marker staining, and tumor HER2 immunohistochemical staining.
The laboratory will have procedures for the calibration of equipment that directly or indirectly affects examination results. Documentary Procedures for the calibration of equipment
The procedures will specify:
NOTE: Information of traceability to a higher order reference material or reference procedure can be provided by an examination system manufacturer. Such documentation is acceptable only when the manufacturer's examination system and calibration procedures are used without modification.
— calibration provided by a competent laboratory; or NOTE 1 Calibration laboratories fulfilling the requirements of ISO/IEC 17025 are considered competent for performing calibrations. — certified values of certified reference materials provided by a competent producer with stated metrological traceability to the SI;
NOTE 2: Reference material producers fulfilling the requirements of ISO 17034 are considered to be competent.
NOTE 3: Certified reference material fulfilling the requirements of ISO 15194 are considered suitable.
— results of reference measurement procedures, specified methods or consensus standards, that are clearly described and accepted as providing measurement results fit for their intended use and ensured by suitable comparison; — measurement of calibrator by another procedure. NOTE ISO 17511 provides further information on how to manage the compromises in the metrological traceability of measurands.
The laboratory will have processes for the selection, procurement, reception, storage, acceptance testing and inventory management of reagents and consumables.Process for the Selection, Procurement, Reception, Storage, Acceptance testing and Inventory management of reagents and consumables
NOTE: Reagents include substances which are commercially supplied or prepared in-house, reference materials (calibrators and QC materials), culture media; consumables include pipette tips, glass slides, POCT supplies etc.
The laboratory will store reagents and consumables according to manufacturers' specifications and monitor the environmental conditions where relevant. When the laboratory is not the receiving facility, it will verify that the receiving facility has adequate storage and handling capabilities to maintain supplies in a manner that prevents damage and deterioration.
Each reagent or new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, will be verified for performance before placing into use, or before release of results, as appropriate. Consumables that can affect the quality of examinations will be verified for performance before placing into use. Reagent lot verification
NOTE 1: Comparative IQC performance of new reagent lots and that of previous lots can be used as evidence for acceptance (see 7.3.7.2). Patient samples are preferred when comparing different reagent lots to avoid issues with commutability of IQC materials.
NOTE 2: Verification can sometimes be based on the certificate of analysis of the reagent.
The laboratory will establish an inventory management system for reagents and consumables. The system for inventory management will segregate reagents and consumables that have been accepted for use from those that have been neither inspected nor accepted for use.Reagent & Consumables stock records
Instructions for the use of reagents and consumables, including those provided by manufacturers, will be readily available. Reagents and consumables will be used according to the manufacturer's specifications Instruction for use of reagents
Adverse incidents and accidents that can be attributed directly to specific reagents or consumables will be investigated and reported to either the manufacturer or supplier, or both, and appropriate authorities, as required. The laboratory will have procedures for responding to any manufacturer's recall or other notice and taking actions recommended by the manufacturer.
Records will be maintained for each reagent and consumable that contributes to the performance of examinations. These records will include, but not be limited, to the following:
The laboratory will have a procedure to establish and periodically review agreements for providing laboratory activities. Procedure to establish and periodically review agreements
The procedure will ensure:
Laboratory users will be informed of any changes to an agreement that can affect examination results. Records of reviews, including any significant changes, will be retained.
Service agreements between the laboratory and other parts of the organization using laboratory supported POCT, will ensure that respective responsibilities and authorities are specified and communicated.
NOTE: Established multidisciplinary POCT committees can be used to manage such service agreements as described in Annex A.
The laboratory will ensure that externally provided products and services that affect laboratory activities are suitable when such products and services are:
It can be necessary to collaborate with other organizational departments or functions to fulfil this requirement.
NOTE: Services include, e.g. sample collection services, pipette and other calibration services, facility and equipment maintenance services, EQA programmes, referral laboratories and consultants.
The laboratory will communicate its requirements to referral laboratories and consultants who provide interpretations and advice, for:
Unless otherwise specified in the agreement, the referring laboratory (and not the referral laboratory) will be responsible for ensuring that examination results of the referral laboratory are provided to the person making the request. A list of all referral laboratories and consultants will be maintained.
The laboratory will have procedures and retain records for: Documentary procedure for defining the criteria for qualification, selection, evaluation of performance and re-evaluation of external providers
The laboratory will identify potential risks to patient care in the pre-examination, examination and post-examination processes. These risks will be assessed and mitigated to the extent possible. The residual risk will be communicated to users as appropriate. The identified risks and effectiveness of the mitigation processes will be monitored and evaluated according to the potential harm to the patient. The laboratory will also identify opportunities to improve patient care and develop a framework to manage these opportunities.
The laboratory will have procedures for all pre-examination activities and make them accessible to relevant personnel.
NOTE 1: The pre-examination processes can influence the outcome of the intended examination.
NOTE 2: ISO 20658 provides detailed information for sample collection and transport.
NOTE 3: ISO 20186-1, ISO 20186-2, ISO 20186-3, ISO 20166 (all parts), ISO 20184 (all parts), ISO 23118 and ISO 4307 provide detailed information for samples from particular sources and for specific analytes.
The laboratory will have appropriate information available for its users and patients. The information will be sufficiently detailed to provide laboratory users with a comprehensive understanding of the laboratory's scope of activities and requirements. The information will include as appropriate:
1. Each request accepted by the laboratory for examination(s) will be considered an agreement.
2. The examination request will provide sufficient information to ensure:
3. The examination request information may be provided in a format or medium as deemed appropriate by the laboratory and acceptable to the user.
4. Where necessary for patient care, the laboratory will communicate with users or their representatives, to clarify the user's request.
The laboratory will have a procedure for managing oral requests for examinations, if applicable, that includes the provision of documented confirmation of the examination request to the laboratory, within a given time. Procedure to manage Oral requests
The laboratory will have procedures for the collection and handling of primary samples. Sample collection manual Information will be available to those responsible for sample collection. Any deviation from the established collection procedures will be clearly recorded. The potential risk and impact on the patient outcome of acceptance or rejection of the sample will be assessed, recorded and shall be communicated to the appropriate personnel. The laboratory will periodically review requirements for sample volume, collection device and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte.
The laboratory will provide information and instructions for pre-collection activities with sufficient detail to ensure that the integrity of the sample is not compromised. This will include:
1. The laboratory will obtain the informed consent of the patient for all procedures carried out on the patient. Consent Form
NOTE: For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample collecting procedure, for example, venipuncture.
2. Special procedures, including more invasive procedures, or those with an increased risk of complications to the procedure, may need a more detailed explanation and, in some cases, recorded consent.
3. If obtaining consent is not possible in emergency situations, the laboratory may carry out necessary procedures, provided they are in the patient’s best interest.
To ensure safe, accurate and clinically appropriate sample collection and pre-examination storage, the laboratory will provide instructions for:
1. To ensure the timely and safe transportation of samples, the laboratory will provide instructions for:
2. If the integrity of a sample has been compromised and there is a health risk, the organization responsible for the transport of the sample will be notified immediately and action taken to reduce the risk and to prevent recurrence.
3. The laboratory will establish and periodically evaluate adequacy of sample transportation systems.
The laboratory will have a procedure for sample receipt Procedure for sample receipt that includes:
1. The laboratory will have a process that considers the best interests of the patient in receiving care, when a sample has been compromised due to
2. When a compromised clinically critical or irreplaceable sample is accepted, after consideration of the risk to patient safety, the final report will indicate the nature of the problem and where applicable, advising caution when interpreting results that can be affected.
The laboratory will have procedures and appropriate facilities for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage. Documentary Procedures for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage
Laboratory procedures will include time limits for requesting additional examinations on the same sample.
Considering the stability of the analyte in a primary sample, the time between sample collection and performing the examination will be specified and monitored where relevant.
1. The laboratory will select and use examination methods which have been validated for their intended use to assure the clinical accuracy of the examination for patient testing. Documentary Procedure for Validation & Verification of examination methods
NOTE: Preferred methods are those specified in the instructions for use of in vitro diagnostic medical devices or those that have been published in established/authoritative textbooks, peer-reviewed texts, or journals, or in international and national consensus standards or guidelines, or national or regional regulations.
2. The performance specifications for each examination method will relate to the intended use of that examination and its impact on patient care.
3. All procedures and supporting documentation, such as instructions, standards, manuals and reference data relevant to the laboratory activities, shall be kept up to date and be readily available to personnel.
4. Personnel will follow established procedures and the identity of persons performing significant activities in examination processes be recorded, including POCT operators.
5. Authorized personnel will periodically evaluate the examination methods provided by the laboratory to ensure they are clinically appropriate for the requests received.
1. The laboratory will validate examination methods derived from the following sources: a) Laboratory designed or developed methods; b) Methods used outside their originally intended scope
2. The validation will be as extensive as is necessary and confirm, through the provision of objective evidence in the form of performance specifications, that the specific requirements for the intended use of the examination have been fulfilled. The laboratory will ensure that the extent of validation of an examination method is sufficient to ensure the validity of results pertinent to clinical decision making.
3. Personnel with the appropriate authorization and competence will review the validation results and record whether the results meet the specified requirements.
4. When changes are proposed to a validated examination method, the clinical impact will be reviewed, and a decision made as to whether to implement the modified method.
The following records of validation will be retained: 1) The validation procedure used;
2) Specific requirements for the intended use;
3) Determination of the performance specifications of the method;
4) Results obtained;
5) A statement on the validity of the method, detailing its fitness for the intended use.
Biological reference intervals and clinical decision limits, when needed for interpretation of examination results, will be defined and communicated to users.
Biological reference intervals and clinical decision limits will be defined, and their basis recorded, to reflect the patient population served by the laboratory, while considering the risk to patients. Biological Reference Interval
NOTE: Biological reference values, provided by the manufacturer can be used by the laboratory, if the population base of these values is verified and deemed acceptable by the laboratory
Biological reference intervals and clinical decision limits will be periodically reviewed, and any changes communicated to users.
When changes are made to an examination or pre-examination method, the laboratory will review the impact on associated biological reference intervals and clinical decision limits and communicate to the users when applicable.
For examinations that identify presence or absence of a characteristic, the biological reference interval is the characteristic to be identified, e.g. genetic examinations.
a) The laboratory will document its examination procedures to the extent necessary to ensure the consistent application of its activities and the validity of its results. Documentation of Examination Procedure
b) Procedures will be written in a language understood by laboratory personnel and be available in appropriate locations.
c) Any abbreviated document content will correspond to the procedure.
NOTE: Working instructions, flow process diagrams or similar systems that summarize key information are acceptable for use as a quick reference at the workbench, provided that a full procedure is available for reference and that the summarized information is updated as needed, concurrently with the full procedure update.
d) Information from product instructions for use, that contain sufficient information, can be incorporated into procedures by reference.
e) When the laboratory makes a validated change to an examination procedure which could affect interpretation of results, the implications of this will be explained to users.
f) All documents associated with the examination process will be subject to document control.
The laboratory will have a procedure for monitoring the validity of results. The resulting data will be recorded in such a way that trends and shifts are detectable and, where practicable, statistical techniques will be applied to review the results. This monitoring will be planned and reviewed.
Mean & SD Updatation file Final data for range updatation NC For IQC & EQAS LJ Semi, Electrolyte, ABG Abbott Calibration File
a) The laboratory will have an IQC procedure for monitoring the ongoing validity of examination results, according to specified criteria, that verifies the attainment of the intended quality and ensures validity pertinent to clinical decision making.
1) The intended clinical application of the examination should be considered, as the performance specifications for the same measurand can differ in different clinical settings.
2) The procedure should also allow for the detection of either lot-to-lot reagent or calibrator variation, or both, of the examination method. To enable this, the laboratory procedure should avoid lot change in IQC material on the same day/run as either lot-to-lot reagent or calibrator change, or both.
3) The use of third-party IQC material should be considered, either as an alternative to, or in addition to, control material supplied by the reagent or instrument manufacturer.
NOTE: Monitoring of interpretations and opinions can be achieved through regular peer review of examination results.
b) The laboratory will select IQC material that is fit for its intended purpose. When selecting IQC material, factors to be considered will include:
1) Stability with regard to the properties of interest;
2) The matrix is as close as possible to that of patient samples;
3) The IQC material reacts to the examination method in a manner as close as possible to patient samples;
4) The IQC material provides a clinically relevant challenge to the examination method, has concentration levels at or near clinical decision limits and when possible, covers the measurement range of the examination method.
c) If appropriate IQC material is not available, the laboratory will consider the use of other methods for IQC. Examples of such other methods may include:
1) Trend analysis of patient results, e.g. with moving average of patient results, or percentage of samples with results below or above certain values or associated with a diagnosis;
2) Comparison of results for patient samples on a specified schedule to results for patient samples examined by an alternative procedure validated to have its calibration metrologically traceable to the same or higher order references as specified in ISO 17511;
3) Retesting of retained patient samples.
d) IQC will be performed at a frequency that is based on the stability and robustness of the examination method and the risk of harm to the patient from an erroneous result.
e) The resulting data will be recorded in such a way that trends and shifts are detectable and, where applicable, statistical techniques will be applied to review the results.
f) IQC data will be reviewed with defined acceptability criteria at regular intervals, and in a timeframe that allows a meaningful indication of current performance.
g) The laboratory will prevent the release of patient results in the event that IQC fails the defined acceptability criteria.
1) When IQC defined acceptability criteria are not fulfilled and indicate results are likely to contain clinically significant errors, the results will be rejected, and relevant patient samples re-examined after the error has been corrected.
2) The results from patient samples that were examined after the last successful IQC event will be evaluated.
7.3.7.3 Procedure for Storage, Preparation, Analysis, Result submission, RCA & Modification in EQAS
a) The laboratory will monitor its performance of examination methods, by comparison with results of other laboratories. This includes participation in EQA programmes appropriate to the examinations and interpretation of examination results, including POCT examination methods.
b) The laboratory will establish a procedure for EQA enrollment, participation and performance for examination methods used, where such programmes are available.
c) EQA samples will be processed by personnel who routinely perform pre-examination, examination, and post-examination procedures.
d) The EQA programme(s) selected by the laboratory will, to the extent possible:
1) Have the effect of checking pre-examination, examination, and post-examination processes;
2) Provide samples that mimic patient samples for clinically relevant challenges;
3) Fulfill ISO/IEC 17043 requirements.
e) When selecting EQA programme(s), the laboratory should consider the type of target value offered. Target values are:
1) Independently set by a reference method, or
2) Set by overall consensus data, and/or
3) Set by method peer group consensus data, or
4) Set by a panel of experts.
NOTE 1: When method-independent target values are not available, consensus values can be used to determine whether deviations are laboratory- or method-specific.
NOTE 2: Where lack of commutability of EQA materials can hamper comparison between some methods, it can still be useful for comparisons to be made between methods for which it is commutable, rather than relying only on within-method comparisons.
f) When an EQA programme is either not available, or not considered suitable, the laboratory will use alternative methodologies to monitor examination method performance. The laboratory will justify the rationale for the chosen alternative and provide evidence of its effectiveness.
NOTE: Acceptable alternatives include: — Participation in sample exchanges with other laboratories; — Interlaboratory comparisons of the results of the examination of identical IQC materials, which evaluates individual laboratory IQC results against pooled results from participants using the same IQC material; — Analysis of a different lot number of the manufacturer's end-user calibrator or the manufacturer's trueness control material; — Analysis of microbiological organisms using split/ blind testing of the same sample by at least two persons, or on at least two analyzers, or by at least two methods; — Analysis of reference materials considered to be commutable with patient samples; — Analysis of patient samples from clinical correlation studies; — Analysis of materials from cell and tissue repositories.
g) EQA data will be reviewed at regular intervals with specified acceptability criteria, in a time frame which allows for a meaningful indication of current performance.
h) Where EQA results fall outside specified acceptability criteria, appropriate action shall be taken, including an assessment of whether the non-conformance is clinically significant as it relates to patient samples.
i) Where it is determined that the impact is clinically significant, a review of patient results that could have been affected and the need for amendment shall be considered and users advised as appropriate.
==7.3.7.4 Comparability of examination results== Comparability of examination results
a) When either different methods or equipment, or both, are used for an examination, and/or the examination is performed at different sites, a procedure for establishing the comparability of results for patient samples throughout the clinically significant intervals will be specified.
NOTE: The use of patient samples when comparing different examination methods can avoid the difficulties linked to the limited commutability of IQC materials. When patient samples are either not available or impractical, see all options described for IQC and EQA.
b) The laboratory will record the results of comparability performed and its acceptability.
c) The laboratory will periodically review the comparability of results.
d) Where differences are identified, the impact of those differences on biological reference intervals and clinical decision limits will be evaluated and acted upon.
e) The laboratory will inform users of any clinically significant differences in comparability of results.
a) Examination results will be reported accurately, clearly, unambiguously and in accordance with any specific instructions in the examination procedure. The report will include all available information necessary for the interpretation of the results.Report form InformationReport format
b) The laboratory will have a procedure to notify users when examination results are delayed, based on the impact of the delay on the patient.Procedure to notify users
c) All information associated with issued reports will be retained in accordance with management system requirements.Retention of reports
NOTE: For the purposes of this document, reports can be issued as hard copies or by electronic means, provided that the requirements of this document are met.
Results will be reviewed and authorized prior to release. The laboratory will ensure that authorized personnel review the results of examinations and evaluate them against IQC and, as appropriate, available clinical information and previous examination results. Responsibilities and procedures for how examination results are released for reporting, including by whom and to whom, will be specified.Procedure for review & release of reports
Critical valuesFormat Critical value register
When examination results fall within established critical decision limits:
a) The user or other authorized person is notified as soon as relevant, based on clinical information available;
b) Actions taken are documented, including date, time, responsible person, person notified, results conveyed, verification of accuracy of communication, and any difficulties encountered in notification;
c) The laboratory will have an escalation procedure for laboratory personnel when a responsible person cannot be contacted.
a) When agreed with the user, the results may be reported in a simplified way.
b) When results are transmitted as a preliminary report, the final report shall always be forwarded to the user.
c) Records will be kept of all results which are provided orally, including details of verification of accuracy of communication. Such results will always be followed by a report.
d) Special counselling may be needed for examination results with serious implications for the patient (e.g. for genetic or certain infectious diseases). Laboratory management should ensure that these results are not communicated to the patient without the opportunity for adequate counselling.
e) Results of laboratory examinations that have been anonymized may be used for such purposes as epidemiology, demography, or other statistical analyses, provided that all risks to patient privacy and confidentiality are mitigated and in accordance with any either legal or regulatory requirements, or both.
When the laboratory implements a system for automated selection, review, release and reporting of results, it will establish a procedure to ensure that:
a) The criteria for automated selection, review and release are specified, approved, readily available and understood by personnel responsible for authorizing the release of results;
b) The criteria are validated and approved before use, regularly reviewed and verified after changes to the reporting system that can affect their proper functioning and place patient care at risk;
c) Results selected by an automated reporting system for manual review are identifiable; and as appropriate, date and time of selection and review, as well as identity of the reviewer are retrievable;
d) When necessary, rapid suspension of automated selection, review, release and reporting is applied.
Each report will include the following information, unless the laboratory has documented reasons for omitting any items:
1. Unique patient identification, the date of primary sample collection and the date of the issue of the report, on each page of the report;
2. Identification of the laboratory issuing the report;
3. Name or other unique identifier of the user;
4. Type of primary sample and any specific information necessary to describe the sample (e.g. source, site of specimen, macroscopic description);
5. Clear, unambiguous identification of the examinations performed;
6. Identification of the examination method used, where relevant, including, where possible and necessary, harmonized (electronic) identification of the measurand and measurement principle;
NOTE: Logical Observation Identifiers Names and Codes (LOINC) and Nomenclature for Properties and Units (NPU, NGC) and SNOMED CT are examples of electronic identification.
7. Examination results with, where appropriate, the units of measurement, reported in SI units, units traceable to SI units, or other applicable units;
8. Biological reference intervals, clinical decision limits, likelihood ratios or diagrams/nomograms supporting clinical decision limits as necessary;
NOTE: Lists or tables of biological reference intervals can be distributed to users of the laboratory.
9. Identification of examinations undertaken as part of a research or development programme and for which no specific claims on measurement performance are available;
10. Identification of the person(s) reviewing the results and authorizing the release of the report (if not contained in the report, readily available when needed);
11.Identification of any results that need to be considered as preliminary;
12.Indications of any critical results;
13.Unique identification that all its components are recognized as a portion of a complete report and a clear identification of the end (e.g. page number to total number of pages).
Procedures for the issue of amended or revised results will ensure that:
=== 7.4.2 Post-examination handling of samples === Documentary Procedures for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage
The laboratory will specify the length of time samples are to be retained following examination and the conditions under which samples are to be stored. The laboratory will ensure that after the examination, the
The laboratory will have a process for when any aspect of its laboratory activities or examination results do not conform to its own procedures, quality specifications, or the user requirements (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The process will ensure that: Documentary Procedure for Identification and Control of Non-Conformities
a) The responsibilities and authorities for the management of nonconforming work are specified;
b) Immediate and long-term actions are specified and based upon the risk analysis process established by the laboratory;
c) Examinations are halted, and reports withheld when there is a risk of harm to patients;
d) An evaluation is made of the clinical significance of the nonconforming work, including an impact analysis on examination results which were or could have been released prior to identification of the nonconformance;
e) A decision is made on the acceptability of the nonconforming work;
f) When necessary, examination results are revised, and the user is notified;
g) The responsibility for authorizing the resumption of work is specified.
The laboratory will implement corrective action commensurate with the risk of recurrence of the nonconforming work.The laboratory will retain records of nonconforming work and actions.
The laboratory will have access to the data and information needed to perform laboratory activities.
NOTE 1: In this document, “laboratory information systems” includes the management of data and information contained in both computer and non-computerized systems. Some of the requirements can be more applicable to computer systems than to non-computerized systems.
NOTE 2: Risks associated with computerized laboratory information systems are discussed in ISO 22367:2020, A.13.
NOTE 3: The information security controls, strategies and best practices to ensure the preservation of confidentiality, integrity and availability of information, are listed in ISO/IEC 27001:2022, Annex A Information security controls reference.
The laboratory will ensure that the authorities and responsibilities for the management of the information systems are specified, including the maintenance and modification to the information systems that can affect patient care. The laboratory is ultimately responsible for the laboratory information systems.
The system(s) used for the collection, processing, recording, reporting, storage or retrieval of examination data and information will be:
a) Validated by the supplier and verified for functionality by the laboratory before introduction. Any changes to the system, including laboratory software configuration or modifications to commercial off-the-shelf software,will be authorized, documented and validated before implementation;
NOTE 1: Validation and verification include, where applicable, the proper functioning of interfaces between the laboratory information system and other systems such as laboratory equipment, hospital patient administration systems and systems in primary care.
NOTE 2: Commercial off-the-shelf software used within its designed application range can be considered sufficiently validated (e.g. word processing and spreadsheet software, and quality management software programs).
b) Documented, and the documentation readily available to authorized users , including that for day to day functioning of the system;
c) Implemented taking cybersecurity into account, to protect the system from unauthorized access and safeguard data against tampering or loss;
d) Operated in an environment that complies with supplier specifications or, in the case of noncomputerized systems, provides conditions which safeguard the accuracy of manual recording and transcription;
e) Maintained in a manner that ensures the integrity of the data and information and includes the recording of system failures and the appropriate immediate and corrective actions.
Calculations and data transfers will be checked in an appropriate and systematic manner.
The laboratory will have planned processes to maintain operations in the event of failure or during downtime in information systems that affects the laboratory's activities. This includes automated selection and reporting of results.
When the laboratory information system(s) are managed and maintained off-site or through an external provider, the laboratory will ensure that the provider or operator of the system complies with all applicable requirements of this document.
The laboratory will have a processProcess for Complaint, Evaluation & Resolution handling complaints that will include at least the following:
a) A description of the process for receiving, substantiating and investigating the complaint, and deciding what actions will be taken in response; NOTE: The resolution of complaints can lead to implementation of corrective actions or be used as input into the improvement process.
b) Tracking and recording the complaint, including the actions undertaken to resolve it.
c) Ensuring appropriate action is taken. A description of the process for handling complaints will be publicly available.
a) Upon receipt of a complaint, the laboratory will confirm whether the complaint relates to laboratory activities that the laboratory is responsible for and, if so, will resolve the complaint.
b) The laboratory receiving the complaint will be responsible for gathering all necessary information to determine whether the complaint is substantiated.
c) Whenever possible the laboratory will acknowledge receipt of the complaint, and provide the complainant with the outcome and, if applicable, progress reports.
Investigation and resolution of complaints will not result in any discriminatory actions. The resolution of complaints will be made by, or reviewed and approved by, persons not involved in the subject of the complaint in question. Where resources do not permit this, any alternative approach will not compromise impartiality.
The laboratory will ensure that risks associated with emergency situations or other conditions when laboratory activities are limited, or unavailable, have been identified, and a coordinated strategy exists that involves plans, procedures, and technical measures to enable continued operations after a disruption.
Plans will be periodically tested and the planned response capability exercised, where practicable.
The laboratory will:
a) establish a planned response to emergency situations, taking into account the needs and capabilities of all relevant laboratory personnel
b) provide information and training as appropriate to relevant laboratory personnel
c) respond to actual emergency situations
d) take action to prevent or mitigate the consequences of emergency situations, appropriate to the magnitude of the emergency and the potential impact.
NOTE: CLSI GP36-A [35] provides more details.
The laboratory will establish, document, implement and maintain a management system to support and demonstrate the consistent fulfilment of the requirements of this document.
As a minimum, the management system of the laboratory shall include the following:
The laboratory may meet 8.1.1 by establishing, implementing, and maintaining a quality management system (e.g. in accordance with the requirements of ISO 9001). This quality management system will support and demonstrate the consistent fulfilment of the requirements of Clauses 4 to 7 and the requirements specified in 8.2 to 8.9.
The laboratory will ensure that persons doing work under the laboratory’s control are aware of:
Laboratory management will establish, document, and maintain objectives and policies for the fulfilment of the purposes of this document and will ensure that the objectives and policies are acknowledged and implemented at all levels of the laboratory organization. --------QM pdf
NOTE: The management system documents can, but are not required to, be contained in a quality manual.
The objectives and policies will address the competence, quality and consistent operation of the laboratory.
Laboratory management will provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.
All documentation, processes, systems, and records, related to the fulfilment of the requirements of this document will be included in, referenced from, or linked to the management system.
All personnel involved in laboratory activities will have access to the parts of the management system documentation and related information that are applicable to their responsibilities.
The laboratory will control the documents (internal and external) that relate to the fulfilment of this document.
NOTE: In this context, “document” can be policy statements, procedures and related job aids, flow charts, instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and documents of external origin such as laws, regulations, standards and textbooks from which examination methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form or type of medium, such as hard copy or digital.
The laboratory will ensure that: Master list of documents Documentary Procedure for Control of Documents
The laboratory will establish and retain legible records to demonstrate fulfilment of the requirements of this document. Records will be created at the time each activity that affects the quality of an examination is performed.
NOTE: Records can be in any form or type of medium.
The laboratory will ensure that amendments to records can be traced to previous versions or to original observations. Both the original and amended data and files will be kept, including the date and where relevant, the time, of alteration, an indication of the altered aspects and the personnel making the alterations.
1) The laboratory will implement the procedures needed for the identification, storage, protection from unauthorized access and changes, back-up, archive, retrieval, retention time, and disposal of its records.
2) The retention times for records shall be specified.
NOTE 1: In addition to requirements, retention times can be chosen based on identified risks.
3) Reported examination results will be retrievable for as long as necessary or as required.
4) All records will be accessible throughout the entire retention period, legible in whichever medium the laboratory keeps records, and available for laboratory management review (see 8.9).
NOTE 2: Legal liability concerns regarding certain types of procedures (e.g. histology examinations, genetic examinations, pediatric examinations) can require the retention of certain records for much longer times than for other records.
The laboratory will identify risks and opportunities for improvement associated with the laboratory activities to:
NOTE 1: Options to address risks can include identifying and avoiding threats, eliminating a risk source, reducing the likelihood or consequences of a risk, transferring a risk, taking a risk in order to pursue an opportunity for improvement, or accepting risk by informed decision.
NOTE 2: Although this document requires that the laboratory identifies and addresses risks, there is no requirement for any particular risk management method. Laboratories can use ISO 22367 and ISO 35001 for guidance.
NOTE 3: Opportunities for improvement can lead to expanding the scope of the laboratory activities, applying new technology, or creating other possibilities to fulfil patient and user needs.
1) The laboratory will continually improve the effectiveness of the management system, including the pre examination, examination and post-examination processes as stated in the objectives and policies.
2) The laboratory will identify and select opportunities for improvement and develop, document, and implement any necessary actions. Improvement activities shall be directed at areas of highest priority based on risk assessments and the opportunities identified (see 8.5).
NOTE: Opportunities for improvement can be identified through risk assessment, use of the policies, review of the operational procedures, overall objectives, external evaluation reports, internal audit findings, complaints, corrective actions, management reviews, suggestions from personnel, suggestions or feedback from patients and users, analysis of data and EQA results.
3) The laboratory will evaluate the effectiveness of the actions taken.
4) Laboratory management will ensure that the laboratory participates in continual improvement activities that encompass relevant areas and outcomes of patient care.
5) Laboratory management will communicate to personnel its improvement plans and related goals.
The laboratory will seek feedback from its patients, users, and personnel. The feedback will be analyzed and used to improve the management system, laboratory activities and services to users.
Records of feedback will be maintained including the actions taken. Communication will be provided to personnel on actions taken arising from their feedback.
When a nonconformity occurs, the laboratory will:
a) Respond to the nonconformity and, as applicable: 1) take immediate action to control and correct the nonconformity; 2) address the consequences, with a particular focus on patient safety including escalation to the appropriate person.
b) Determine the cause(s) of the nonconformity.
c) Evaluate the need for corrective action to eliminate the cause(s) of the nonconformity, in order to reduce the likelihood of recurrence or occurrence elsewhere, by: 1) reviewing and analyzing the nonconformity; 2) determining whether similar nonconformities exist, or could potentially occur; 3) assessing the potential risk(s) and effect(s) if the nonconformity recurs.
d) Implement any action needed.
e) Review and evaluate the effectiveness of any corrective action taken.
f) Update risks and opportunities for improvement, as needed.
g) Make changes to the management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered and shall mitigate the identified cause(s).
The laboratory will retain records as evidence of the
a) nature of the nonconformities, cause(s) and any subsequent actions taken, and
b) evaluation of the effectiveness of any corrective action.
The laboratory will conduct evaluations at planned intervals to demonstrate that the management, support, and pre-examination, examination, and post-examination processes meet the needs and requirements of patients and laboratory users, and to ensure conformity to the requirements of this document.
The process of monitoring quality indicators will be planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of monitoring. The indicators will be periodically reviewed, to ensure continued appropriateness.
a) conforms to the laboratory’s own requirements for its management system, including the laboratory activities,
b) conforms to the requirements of this document, and
c) is effectively implemented and maintained.
a) priority given to risk to patients from laboratory activities;
b) a schedule which takes into consideration identified risks; the outcomes of both external evaluations and previous internal audits; the occurrence of nonconformities, incidents, and complaints; and changes affecting the laboratory activities;
c) specified audit objectives, criteria and scope for each audit;
d) selection of auditors who are trained, qualified and authorized to assess the performance of the laboratory's management system, and, whenever resources permit, are independent of the activity to be audited;
e) ensuring objectivity and impartiality of the audit process;
f) ensuring that the results of the audits are reported to relevant personnel;
g) implementation of appropriate correction and corrective actions without undue delay;
h) retention of records as evidence of the implementation of the audit programme and audit results.
NOTE: ISO 19011 provides guidance for auditing management systems. —
Laboratory management shall review its management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfilment of this document.
The inputs to management review shall be recorded and shall include evaluations of at least the following: Documentary procedure for management review
The output from the management review shall be a record of decisions and actions related to at least:
Laboratory management shall ensure that actions arising from management review are completed within a specified time frame. Conclusions and actions arising from management reviews shall be communicated to laboratory personnel.