Gap Analysis of ISO 15189 - KENASkenas.go.ke/wp-content/uploads/2013/12/GapAnalysisofISO15189.pdf · Gap Analysis of ISO 15189:2012 and ISO 15189:2007 in the ... Gap analysis of general

KENYA ACCREDITATION SERVICE

P. O. Box 47400-00100, TEL. 254-020-607380, NAIROBI Email: [email protected] Web: www.kenas.go.ke

Gap Analysis of ISO 15189:2012 and ISO 15189:2007 in the field of Medical Laboratories Background Kenya Accreditation Service (KENAS) currently uses the International Standards Organization ISO 15189:2007 as generic accreditation criteria for all medical laboratories. The International Standard ISO 15189:2007 has been undergoing a periodic review and as such ISO has published, in November 2012, the 2012 (3rd edition) of ISO 15189 Medical Laboratories – Requirements for Quality and Competence. The following summarizes the changes and up-dates in the new edition and details the transition requirements for accredited medical laboratories to implement the new standard. New Requirements ISO 15189 Clauses have been expanded to include additional detail and has sort to clarify to ensure effective compliance. In many cases this has not resulted in a change of intent to the requirements. All the new/updated requirements are included in the attached ISO 15189:2012 Transition Table, which has been prepared to highlight the differences between ISO 15189:2007 and ISO 15189:2012. It details the changes and gives guidance from KENAS on the expectations on laboratories in terms of implementation of these requirements. This document may be used by laboratory personnel to assist in the preparation for an external assessment. Summary of changes The most notable differences between ISO 15189:2007 and ISO 15189:2012 include:

Improved layout and expanded listing of sub-clauses, including a general requirements sub-clause, to make it easier to identify specific sub-clauses within the document.

A more logical ordering of sub-clauses, wherever possible, to reflect the expected flow of activities in a laboratory setting. Clause 5.8 of ISO 15189:2007 has been split into the requirements for reporting (5.8) and release of results (5.9). Clause 5.10 is a new section in relation to Laboratory Information Management, aspects extracted from Annex B (previously informative of the previous

edition).



Transitional guidelines to ISO 15189:2012 On 1st November 2012 the standard ISO 15189:2012 Medical Laboratories- Requirements for Quality and Competence was published by ISO. International Laboratory Accreditation Co-Operation (ILAC), published their resolution on the transition period (for ISO 15189:2012) of three (3) years with the final date of transition as 1 March 2016, please see ILAC Secretariat communication below. 1 March 2016, all references to ISO 15189 in accreditation certificates shall be to the new version ILAC General Assembly, RIO DE JANEIRO, BRAZIL 26 OCTOBER 2012 ILAC Resolution GA 16.21 Noting the results of the ISO ballot completed for ISO FDIS 15189 on 11 October 2012, the General Assembly agrees that by 1 March 2016, all references to ISO 15189 in accreditation certificates (as defined and described in ISO/IEC 17011), shall refer to the latest edition of ISO 15189. Compliance will be determined during normal surveillance or reassessment activities or as a separate activity. At the end of the transition period, accreditation of a laboratory to ISO 15189:2007 will not be recognized under the ILAC Arrangement. It is expected that explanatory documents related to ISO 15189 shall be revised more frequently than other KENAS explanatory documents. Medical laboratories accredited against the

Acquiring the new ISO 15189;2012 Copies of this new accreditation standard (ISO 15189:2012) will not be free of charge to all applicant and accredited medical laboratories, therefore copies will need to be sought from the Kenya bureau of standards - or from ISO directly. KENAS will commence assessment of medical laboratories against the requirements of the new standard from 1 October 2013. However, any non-compliance to additional clauses or significant amendments compared to the previous standard will only result in strong recommendations during the initial visit. Corrective Action Requests (CARs) will be raised for any such non-compliances during subsequent visits. This applies to both applicant laboratories at their initial assessment and currently accredited laboratories at their next scheduled annual surveillance visit or routine reassessment after 1 October 2014. KENAS shall not take application to ISO 15189:2007 after 1 October 2014. KENAS, however, shall welcome any application to ISO 15189:2012 after 1August 2013. KENAS assessors will discuss any significant amendments with you at this assessment and, provided your laboratory has demonstrated an appreciation of the subtle changes, will issue you with an up-dated Certificate of Accreditation upon the granting or formal continuation of accreditation following the assessment.



All accredited medical laboratories will be expected to up-date (to the 2012 version) any references to ISO15189:2007 in their management system documentation at the next scheduled review of these policies and procedures. Further Information If you have any queries regarding the implementation of ISO 15189:2012 please do not hesitate to contact the KENAS assistant director – health and safety or the case officer assigned for your next assessment. Gap analysis of general information sections/ transition guidelines Title The name of the standard has been amended to Medical laboratories - Requirements for quality and competence Foreword ISO 15189:2012 now includes a foreword describing the ISO process. Introduction When considering an accreditation body, ISO 15189:2012 includes reference to ISO/IEC 17011 rather than “appropriate International Standards”. The management system requirements in Clause 4 meet the principles of ISO 9001:2008 and are aligned with its pertinent requirements. Specific reference to clauses 5.2.2, 5.2.6, 5.3, 5.4, 5.5.1.4 and 5.7 to address environmental issues has been made. 1. Scope The scope has been expanded to include that, in addition to the Standard being used by accreditation bodies, it may also be used by laboratory customers and regulatory authorities to confirm or recognize the competence of medical laboratories. 2. Normative references The following changes have been made to the normative references: ISO 31, ISO 9000:2005 and ISO 9001:2000, ISO/IEC Guide 43-1 have all been removed; and ISO/IEC 17000, ISO/IEC Guide 2 and ISO/IEC Guide 99 have been included. 3. Terms and definitions The terms and definitions now reference ISO/IEC 17000, ISO/IEC Guide 2 and ISO/IEC Guide 99.

Definitions appearing in ISO 15189:2007 which have been removed from ISO 15189:2012 3.2 Accuracy of measurement 3.5 Laboratory capability



3.8 Measurement 3.13 Quantity 3.17 Traceability 3.18 Trueness of measurement 3.19 Uncertainty of measurement

Definitions appearing in ISO 15189:2007 which have been renumbered and/or amended in ISO 15189:2012

3.3 biological reference interval is now 3.4 This has been amended and further notes have been included.

3.4 Examination is now 3.7 Additional notes have been included.

3.6 Laboratory director is now 3.9 3.7 Laboratory management is now 3.10

This has been amended, with „headed by a laboratory director‟ removed.

3.9 Medical laboratory / clinical laboratory is now 3.11 Genetic facilities and the management of patients have been included.

3.10 post-examination processes / post-analytical phase is now 3.14 This has been amended slightly and includes “retention and storage of clinical material, sample (and waste) disposal”.

3.11 pre-examination processes / pre-analytical phase is now 3.15 3.12 primary sample / specimen is now 3.16

This has been amended and includes samples of body fluid, breath, hair or tissue. Additional notes have also been included.

3.14 quality management system definition is now 3.20 3.15 referral laboratory definition is now 3.23

This has been amended slightly and a note has been added.

3.16 sample definition is now 3.24 This has been amended slightly. Definitions appearing in ISO 15189:2012 only



3.2 Alert interval/critical interval 3.3 Automated selection and reporting of results 3.5 Competence 3.6 Documented procedure 3.8 Interlaboratory comparison

Reference is made to ISO/IEC 17043:2010.

3.12 Nonconformity 3.13 Point-of-care testing / POCT / near patient testing 3.17 Process 3.18 Quality 3.19 Quality indicator 3.21 Quality policy 3.22 Quality objective 3.25 Turnaround time 3.26 Validation 3.27 Verification

ISO 15189:2012 Transition Table ISO 15189:2012 has undergone a major editorial rewrite. Due to the number of editorial changes included in this latest version, only those of significance will be listed in the below table. The onus is on facility staff to become familiar with ISO 15189:2012 in its entirety and ensure compliance with the requirements detailed in the Standard 15189:2012 Clause No.

& Title

15189:2007 Clause No. &

Title

Change Extract of ISO 15189:2012 KENAS Comment

Section 4: Management Requirements

4.1 Organisation and Management Responsibility 4.1.1 Organisation and 4.1.2 Management Responsibility



4.1.1.1 General

4.1.3 Amended Addition of mobile facilities where laboratory work is performed which are to be covered by this International Standard.

4.1.1.2 Legal entity

4.1.1 Amended Change from being legally identifiable to an entity that can be held legally responsible for its activities.

4.1.1.3 Ethical conduct

4.1.5d), 4.1.5b), 4.1.4, , 4.1.5c),

Editorial Amended New

d) there are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements.

Several sub clauses have been consolidated and clauses amended. There is to be no involvement in activities that would diminish confidence in the laboratory’s services rather than avoiding involvement. Conflicts of interest to be declared rather than just defined in the quality management system. Relevant health and safety requirements for transporting, handling and disposal. Awareness and respect for cultural requirements.

4.1.4 Laboratory Director

4.1.5, 4.1.6, 5.1.3, 5.1.4, 5.1.5

Editorial/New New

The laboratory director shall: d) ensure the implementation of the quality policy h) select and monitor laboratory supplies n) design and implement a contingency plan to ensure that essential services are available during emergency situations or other conditions when laboratory services are limited or unavailable

New sections and additional sub clauses from 4.1, 4.2 and 5.1. Some additional responsibilities for the laboratory director.



Amended Deleted

m) Address any complaint, request or suggestion from staff and/or users of laboratory services.

The responsibility for the laboratory director to ensure staff morale has been removed.

4.1.2.1 Management commitment

4.1.5, 4.2.3 Amended Some additional responsibilities for laboratory management, however no significant changes from the current management systems already established. Management commitment to establishing the quality policy and conducting management review is now specified.

4.1.2.2 Needs of the user

New Laboratory management shall ensure that laboratory services, including appropriate advisory and interpretative services, meet the needs of patients and those using the laboratory services.

4.1.2.3 Quality policy

4.2.3 Amended The intent of the laboratory’s quality management system is to be defined in a quality policy.



4.1.2.4 Quality objectives and planning

New Laboratory management shall establish quality objectives, including those to meet the needs and requirements of the users, at relevant functions and levels within the organisation. The quality objectives shall be measurable and consistent with the quality policy. Laboratory management shall ensure the planning of the quality management system is carried out to meet the requirements and the quality objectives.

Laboratory management shall ensure that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

4.1.2.5 Responsibility, authority and interrelationships

4.1.5 a), e), f), j)

Amended The laboratory is now required to ensure that responsibilities, authorities and interrelationships are all defined, documented and communicated.

4.1.2.6 Communication

4.1.6 Amended New

Records shall be kept of items discussed in communications and meetings.

Effective communication must be established both within the laboratory and with its stakeholders.

4.1.2.7 Quality manager

4.1.5 i) Amended The quality manager’s responsibilities have been expanded to include ensuring the promotion of the awareness of users‟ needs and requirements throughout the laboratory organisation.

4.2 Quality Management System



4.2 4.2.1 General requirements 4.2.2 Documentation requirements

4.2 Significant editorial This clause has been substantially rearranged and rewritten. The general intent, however, remains the same.

4.2.2.2 Quality manual

4.2.4 Significant editorial The quality manual needs to include descriptions of integral elements of the quality management system, laboratory management and a number of documented policies. ISO 15189:2007 included an indication of what may be included in the table of contents of a quality manual. This has been removed from ISO 15189:2012.

4.3 Document control 4.3 4.3 Amended

New Deleted

b) All documents are identified to include: - a unique identifier on each page

- page number to total number of pages f) Changes to documents are identified. g) Documents remain legible. From ISO 15189:2007: “procedures are established to describe how changes to documents maintained in computerised systems are to be made and controlled.

This clause has been substantially rearranged and rewritten.

4.4 Service agreements



4.4 4.4.1 Establishment of service agreements 4.4.2 Review of service agreements

4.4 Significant editorial There has been a change to clause name. The clause has been substantially rewritten and rearranged. The general intent, however, remains.

4.5 Examination by referral laboratories

4.5.1 Selecting and evaluating referral laboratories and consultants

4.5.1, 4.5.2, 4.5.3

Amended Amended Deleted

A register of all referral laboratories, and consultants from whom opinions are sought, is maintained. 4.5.2 a) to d) in ISO 15189:2007

The requirements have been expanded to ensure that the documented procedures for selecting and evaluating consultants who provide opinions and interpretation for complex testing relates to consultants in any discipline and not just for cytology, histopathology and related disciplines. Details of what is required to be reviewed has been removed.



Amended Deleted

Requests and results of all samples referred are kept for a pre-defined period. A duplicate of the laboratory report shall be retained in both the patient record and in the permanent file of the laboratory.

4.5.2 Provision of examination results

4.5.4 Amended New

The report shall indicate which examinations were performed by a referral laboratory or consultant.

The laboratory now has the option to specify in an agreement if the referral laboratory will be responsible for providing results directly to the requester.

4.6 External services and supplies 4.6 4.6 Significant editorial Requirements for receipt and storage, acceptance

testing, inventory management, instructions for use, adverse incident reporting and records have been included under 4.13 and 5.3.2

4.7 Advisory services



4.7 4.7 Amended New

b)advising on individual clinical cases; c)professional judgments on the interpretation of the results of examinations; d) promoting the effective utilization of laboratory services; e) consulting on scientific and logistic matters such as instances of failure of sample(s) to meet acceptance criteria.

Additional services have been defined.

Deleted

From ISO 15189:2007: “There should be regular documented meetings of professional staff with the clinical staff regarding the use of the laboratory services and for the purpose of consultation on scientific matters. The professional staff should participate in clinical rounds, enabling advice on effectiveness in general as well as in individual cases.”

4.8 Resolution of complaints 4.8 4.8 no significant changes

4.9 Identification and control of nonconformities



4.9 4.9.1, 4.9.2, 4.9.3

Amended “…to identify and manage nonconformities in any aspect of the quality management system, including pre-examination, examination or post- examination processes.” “…and, where appropriate, requesting clinician or authorised individual responsible for using the results is informed.”

4.10 Corrective action 4.10 4.10.1,4.10.2,

4.10.3 4.10.4

Editorial Deleted

The laboratory shall take corrective action to eliminate the cause(s) of nonconformities.

The requirement to audit areas where doubt is cast on the compliance with policies and procedures has been removed.

4.11 Preventive action 4.11 4.11.1, 4.11.2 Amended Documented procedures for preventive action need to

include a number of additional criteria.

4.12 Continual improvement



4.12 4.12.1, 4.12.2, 4.12.3 4.12.4 4.12.5

New Amended Deleted

Improvement activities shall be directed at areas of highest priority based on risk assessments From ISO 15189:2007: “Laboratory management shall provide access to suitable educational and training opportunities for all laboratory personnel and relevant users of laboratory services not specifically mentioned.”

Laboratory management shall communicate to staff improvement plans and related goals.

4.13 Control of records 4.13 4.13.1, 4.13.2,

4.13.3, 4.6.3, 4.6.4

Editorial New Amended

Records shall be created concurrently with performance of each activity that affects the quality of the examination. The date and, where relevant, the time of amendments to records shall be captured along with the identity of personnel making the amendments. All of these quality and technical records shall be available for laboratory management review

There has been a change to clause name and all previous sub clauses have been combined under one clause and 4.6.3 and 4.6.4 have been moved to this clause. The list of records to be controlled is now a „must‟ rather than a „may‟ The list also includes additional quality related records (e.g supplier selection and performance, minutes of meetings that record decisions etc)



4.14 Evaluation and audits 4.14 4.14.1 General

4.14 Significant editorial There has been a change to the clause name. Substantially rewritten and expanded to now include other areas of evaluation not just internal audits.

4.14.2 Periodic review of requests, and suitability of procedures and sample requirements

Amended New

The laboratory shall periodically review its sample volume, collection device and preservative requirements for blood, urine, other body fluids, tissue and other sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected and the sample is properly collected to preserve the measurand.

The examinations provided by the laboratory are to be reviewed periodically to ensure they are clinically appropriate.

4.14.3 Assessment of user feedback

4.8 Note New The laboratory shall seek information relating to user perception as to whether the service has met the needs and requirements of users. The methods for obtaining and using this information shall include cooperation with users or their representatives in monitoring the laboratory‟s performance, provided that the laboratory ensures confidentiality to other users. Records shall be kept of information collected and actions taken.

Previously laboratories were encouraged to seek both positive and negative feedback from the users of their services.



4.14.4 Staff suggestions

New Laboratory management shall encourage staff to make suggestions for the improvement of any aspect of the laboratory service. Suggestions shall be evaluated, implemented as appropriate and feedback provided to the staff. Records of suggestions and action taken by the management shall be maintained.

4.14.5 Internal audit

4.14.1, 4.14.2, 4.14.3

Amended There is now a greater focus on the audit programme taking into account the importance of the processes and technical and management areas to be audited, as well as the results of previous audits.



New

Personnel responsible for the area being audited shall ensure that appropriate action is promptly undertaken when nonconformities are identified. Corrective action shall be taken without undue delay to eliminate the causes of the detected nonconformities.

Reference: to quality manager or designated qualified personnel to carry out internal audits has been replaced with personnel trained to assess the performance of managerial and technical processes of the quality management system. Rather than the prescriptive requirement of personnel not auditing their own activities, the laboratory must ensure that the conduct of audits is objective and impartial and wherever resources permit, auditors are to be independent of the activity to be audited. The expected cycle of internal auditing activities is now contained in a Note.

4.14.6 Risk management

New The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken.



4.14.7 Quality Indicators

4.12.4, 5.8.11 Amended New

The process of monitoring quality indicators shall be planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement.

Quality indicators are required to be established to monitor and evaluate performance throughout critical aspects of all stages of examination processes.

5.8.2, 5.8.11 Significant editorial Turnaround times for each examination has been moved from “Reporting” to “Evaluation”. The laboratory must periodically evaluate whether or not it is meeting the established turnaround times.

4.14.8 Reviews by external organisations

New When reviews by external organisations indicate the laboratory has nonconformities or potential nonconformities, the laboratory shall take appropriate immediate actions and, as appropriate, corrective action or preventive action to ensure continuing compliance with the requirements of this International Standard. Records shall be kept of the reviews and of the corrective actions taken.

4.15 Management review 4.15 4.15.1 General

Significant editorial This clause has been reworded and separated into review input, activities and output. The expected period of conducting management review has been moved to a Note.



4.15.2 Review input

4.15.2 Amended The number of inputs into management review has been expanded to encompass Section 4 activities.

4.15.3 Review activities

4.15.1, 4.15.3 Amended Management review must analyse the input information for causes of nonconformities, trends and patterns that indicate process problems. There is also the need to assess opportunities for improvement.

4.15.4 Review output

4.15.4 Amended Records of management review are to include any decisions made and actions taken which relate to the improvement of the effectiveness of the quality management system and its processes; improvement of services to users; and resource needs.

Section 5: Technical Requirements

5.1 Personnel 5.1 5.1.1 General

5.1 Significant editorial The clause has been substantially rewritten to divide personnel requirements into different sections. The requirement outlining the responsibilities of the laboratory director has been moved to sub clause 4.1.1.4.



5.1.2 Personnel Qualifications 5.1.3 Job Descriptions

5.1.1, 5.1.2 New Laboratory management shall document personnel qualifications for each position.

5.1.4 Personnel introduction to the organisational environment

New The laboratory shall have a programme to introduce new staff to the organisation, the department or area in which the person will work, the terms and conditions of employment, staff facilities, health and safety requirements (including fire and emergency), and occupational health services.

5.1.5 Training

5.1.6, 5.1.10

Amended New

Personnel that are undergoing training shall be supervised at all times. The effectiveness of the training programme shall be periodically reviewed.

There has been expansion of the training requirements, detailing what areas must be covered in a training programme including health and safety and ethics.

5.1.6 Competence assessment

5.1.11 Significant editorial The Note included under this sub-clause provides examples of approaches to competency assessments.



5.1.7 Review of staff performance

In addition to the assessment of technical competence, the laboratory shall ensure that reviews of staff performance consider the needs of the laboratory and the individual in order to maintain or improve the quality of service given to the users and encourage productive working relationships.

There is a Note included that staff performing reviews should receive appropriate training.

5.1.8 Continuing education and professional development

5.1.9, 5.1.12 Amended New

The effectiveness of the continuing education programme shall be periodically reviewed.

A continuing education programme is required to be available to all personnel who participate in managerial and technical processes and participation is mandatory.

5.1.9 Personnel records

5.1.2 Amended There has been an expansion of the records required to be maintained. This is now a „shall‟ as opposed to a ‟may‟ in ISO 15189:2007.

5.2 Accommodation and environmental conditions 5.2 5.2 Significant editorial This clause has been restructured into designated

accommodation areas, including laboratory and office facilities, storage facilities, staff facilities and patient sample collection facilities. Facility maintenance and environmental conditions are also clearly defined.

5.2.1 General

5.2.1 Amended Sufficiency and adequacy of allocated space for point-of- care testing under the laboratory’s management has been included.



5.2.2 Laboratory and office facilities

5.2.4, 5.2.7,5.2.8

Amended There is an additional requirement for safety facilities and devices to be provided and their functioning regularly verified.

5.2.3 Storage facilities

5.2.9, 5.2.10 Amended Included is the requirement for clinical samples and materials used in examination processes to be stored in a manner which prevents cross contamination.

5.2.4 Staff facilities

New There shall be adequate access to washrooms, to a supply of drinking water and to facilities for storage of personal protective equipment and clothing.

When possible laboratories should also provide space for staff activities such as meetings and quiet study and a rest area.

5.2.5 Patient sample collection facilities

5.2.2, 5.2.3, 5.2.4

Amended/New Patient sample collection facilities shall have a separate reception/waiting and collection areas. Sample collection facilities shall have and maintain appropriate first aid material for both patient and staff needs.

5.2.6 Facility maintenance and environmental conditions

5.2.1, 5.2.5, 5.2.6, 5.2.10

Amended The monitoring of environmental conditions has been extended to also include where they may influence the health of staff.

5.3 Laboratory equipment, reagents, and consumables 5.3.1 Equipment and 5.3.2 Reagents and consumables



5.3 4.6, 5.3 Significant editorial Parts of 4.6 from the 2007 version have been incorporated into 5.3 in the 2012 version. Requirements for laboratory equipment have been divided into general, acceptance testing, instructions for use, calibration and metrological traceability, equipment maintenance and repair, adverse incident reporting and records. Requirements for reagents and consumables have been divided into general, reception and storage), acceptance testing, inventory management), instructions for use, adverse incident reporting and records.

5.3.1.1 General

4.6.1, 5.3.1 Editorial New

The laboratory shall replace equipment as needed to ensure the quality of examination results.

Documented procedures are required for the selection, purchasing and management of equipment.

Deleted

From ISO 15189:2007: “When selecting equipment account should be taken of the use of energy and future disposal (care of the environment).”

5.3.1.2 Equipment acceptance testing

5.3.2, 5.3.3 Editorial A note has been included specifying that the requirement applies to equipment used in the laboratory, on loan or used in associated or mobile facilities by others authorised by the laboratory.

5.3.1.3 Equipment instructions for use

5.3.5, 5.3.12 Amended Expanded to require personnel operating equipment to be trained and authorised.



5.3.1.4 Equipment calibration and metrological traceability

5.3.2, 5.3.9, 5.3.13, 5.3.14

New New

The laboratory shall have a documented procedure for the calibration of equipment that directly or indirectly affects examination results. Metrological traceability shall be to a reference material or reference procedure of the higher metrological order available.

5.3.1.5 Equipment maintenance and repair

5.3.2, 5.3.6, 5.3.7, 5.3.8, 5.3.9, 4.6.2 5.6.3

Significant editorial A number of clauses from the 2007 version have been combined in a single clause.

5.3.1.6 Equipment adverse incident reporting

New Adverse incidents and accidents that can be attributed directly to specific equipment shall be investigated and reported to the manufacturer and appropriate authorities, as required.

5.3.1.7 Equipment records

5.3.3, 5.3.4 Editorial/Amended Deleted

The performance records that confirm the equipment’s ongoing acceptability for use now must include copies of reports/certificates of all calibrations and/or verifications, where this was a „should‟ in the 2007 version. Equipment records are no longer required to include the predicted replacement date if possible.

5.3.2.1 General

4.6.1 Editorial Documented procedures are required for the reception, storage, acceptance testing and inventory management of reagents and consumables.



5.3.2.2 Reagents and consumables – Reception and storage

New Where the laboratory is not the receiving facility, it shall verify that the receiving location has adequate storage and handling capabilities to maintain purchased items in a manner that prevents damage or deterioration. The laboratory shall store received reagents and consumables according to manufacturer‟s specifications.

5.3.2.3 Reagents and consumables – Acceptance testing

4.6.2 Amended/New Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, shall be verified for performance before use in examinations.

5.3.2.4 Reagents and consumables – Inventory management

4.6.3 New The system for inventory control shall segregate uninspected and unacceptable reagents and consumables from those that have been accepted for use.

5.3.2.5 Reagents and consumables – Instructions for use

New Instructions for use of reagents and consumables, including those provided by the manufacturers, shall be readily available.

5.3.2.6 Reagents and consumables – Adverse incident recording

New Adverse incidents and accidents that can be attributed directly to specific reagents or consumables shall be investigated and reported to the manufacturer and appropriate authorities, as required.



5.3.2.7 Reagents and consumables – Records

4.6.3 Amended New

Where the laboratory uses reagents prepared or completed in-house, the records shall include, in addition to the relevant information above, reference to the person or persons undertaking the preparation and the date of preparation.

There has been an expansion of the records required to be retained relating to reagents and consumables.

5.4 Pre-examination processes 5.4 5.4 Significant editorial This clause has been substantially rewritten and

restructured.

5.4.1 General

New The laboratory shall have documented procedures and information for pre-examination activities to ensure the validity of the results of examinations.

5.4.2 Information for patients and users

5.4.3 Amended/New Some additions have been made to the information which is required to be available to patients and users of the laboratory services. The source of the information is no longer restricted to the primary collection manual. New requirements include opening hours of the laboratory, types of clinical services offered by the laboratory including examinations referred to other laboratories and a list of factors known to significantly affect the performance of the examination or the interpretation of the results.



5.4.3 Request form information


The laboratory shall be willing to cooperate with users or their representatives in clarifying the user’s request.

A number of additional details are to be included on the request form (or electronic equivalent) in relation to patient information. The inclusion of the specified details is now a “shall” where it was a „should‟ in the 2007 version. The date of sample collection is a requirement, however the time of collection is only required where relevant.

5.4.4 Primary sample collection and handling

5.4.2, 5.4.3 Significant editorial The requirements for primary collection and handling have been split into general, pre-collection activities and collection activities.

5.4.4.1 General

5.4.2 New Where the user requires deviations and exclusions from, or additions to, the documented collection procedure, these shall be recorded and included in all documents containing examination results and shall be communicated to the appropriate personnel. Special procedures, including more invasive procedures, or those with an increased risk of complications to the procedure, will need a more detailed explanation and, in some cases, written consent. In emergency situations, consent might not be possible; under these circumstances it is acceptable to carry out necessary procedures, provided they are in the patient’s best interest.



5.4.4.2 Instructions for pre-collection activities

5.4.3 Editorial/Amended The requirement to include instructions on any necessary additives to primary sample containers has been added.

5.4.4.3 Instructions for collection activities

5.4.3 Editorial New

d) in situations where the primary sample is collected as part of clinical practice, information and instructions regarding primary sample containers, any necessary additives and any necessary processing and sample transport conditions shall be determined and communicated to the appropriate clinical staff.

5.4.5 Sample transportation

5.4.6 New The laboratory’s instructions for post-collection activities shall include packaging of samples for transportation.

5.4.6 Sample reception

5.4.7, 5.4.8, 5.4.10, 5.4.11, 5.4.12 5.4.9

Editorial/Amended Deleted

The date and time of receipt and/or registration of samples shall be recorded. Wherever possible, the identity of the person receiving the sample shall also be recorded The requirement for a laboratory to periodically review its sample volume requirements has been removed.

5.4.7 Pre-examination handling, preparation and storage

5.4.14 Amended Laboratory procedures need to specify time limits for requesting additional or further examinations on the same primary sample.

5.5 Examination processes



5.5 5.5 Significant editorial This clause has been rewritten and restructured and clearly divided into three sub-clauses

5.5.1 Selection, verification and validation of examination procedures 5.5.1.1 General

5.5.2, 5.5.4 Amended The identity or persons performing activities in examination processes must be recorded.

5.5.1.2 Verification of examination procedures

5.5.2 Amended New

The laboratory shall obtain information from the manufacturer/method developer for confirming the performance characteristics of the procedure.

Validated examination procedures used without modification must be subject to independent verification by the laboratory prior to use. The laboratory is required to have verification results reviewed by staff with appropriate authority. There is no longer a specific requirement to annually review methods and procedures used in the laboratory.



5.5.1.3 Validation of examination procedures


When changes are made to a validated examination procedure, the influence of such changes shall be documented and, when appropriate, a new validation shall be carried out.

Greater detail regarding the situations when validation of examination procedures is required has been included in this clause. Validation must be performed for non-standard methods, laboratory developed methods, standard methods used outside their intended scope and validated methods subsequently modified. The laboratory is required to have validation results reviewed by staff with appropriate authority.



5.5.1.4 Measurement uncertainty of measured quantity values

5.6.2 Amended New

The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty. The laboratory shall consider measurement uncertainty when interpreting measured quantity values. Upon request, the laboratory shall make estimates of uncertainty available to laboratory users. Where examinations include a measurement step but do not report a measured quantity value, the laboratory should calculate the uncertainty of the measurement step where it has utility in assessing the reliability of the examination procedure or has influence on the reported result.

Previously the laboratory was required to determine the uncertainty of results, where relevant and possible. Now the laboratory must determine measurement uncertainty (MU) for each measurement procedure in the examination phase used to report measured quantity values on patients‟ samples.

5.5.2 Biological reference intervals or clinical decision limits

5.5.5 Amended The basis for the biological reference intervals or clinical decision values must be documented and communicated to users of the laboratory service.



5.5.3 Documentation of examination procedures

5.5.3, 5.5.7

Amended Deleted

From ISO 15189:2007: “Each new version of examination kits with major changes in reagents or procedure shall be checked for performance and suitability for intended use. Any procedural changes shall be dated and authorised as for other procedures.”

The information to be included in the documentation of examination procedures is now a „shall‟ where it was a “should” in the 2007 version. Additional items for procedures include: patient preparation; instructions for determining the quantitative results where the result is not within the measurement interval; and references. The requirement for the laboratory to make its list of

5.6 Ensuring quality of examination results 5.6 5.6 Significant editorial There has been a change to the clause name and major

rewording of the clause, with sub-clauses created to separate quality control (5.6.2) and inter-laboratory comparisons (5.6.3).

5.6.1 General

New The laboratory shall ensure the quality of examinations by performing them under defined conditions. Appropriate pre and post- examination processes shall be implemented. The laboratory shall not fabricate any results.

5.6.2 Quality Control

5.6.2.1 General

5.6.1



5.6.2.2 Quality control materials

5.6.1 New The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples. Quality control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result.

5.6.2.3 Quality control data

New The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the quality control rules are violated and indicate that examination results are likely to contain clinically significant errors, the results shall be rejected and relevant patient samples re-examined after the error condition has been corrected and within-specification performance is verified. The laboratory shall also evaluate the results from patient samples that were examined after the last successful quality control event. Quality control data shall be reviewed at regular intervals to detect trends in examination performance that may indicate problems in the examination system. When such trends are noted, preventive actions shall be taken and recorded.



5.6.3 Interlaboratory comparisons

5.6.3.1 Participation

5.6.4 Amended The requirement for interlaboratory comparison programmes to be in substantial agreement with ISO/IEC Guide 43-1 has been replaced with a note that they should substantially fulfill the relevant requirements of ISO/IEC 17043.

New The laboratory shall establish a documented procedure for interlaboratory comparison participation that includes defined responsibilities and instructions for participation, and any performance criteria that differ from the criteria used in the laboratory comparison programme.

5.6.3 Deleted Some of the content of this clause from ISO 15189:2007 relating to calibration for measuring systems is now included in 5.3.1.4.

5.6.3.2 Alternative approaches

5.6.5 Amended Some additional examples of alternative approaches have been included for when there is no interlaboratory comparison programme available.



5.6.3.3 Analysis of interlaboratory comparison samples

New The laboratory shall integrate interlaboratory comparison samples into the routine workflow in a manner that follows, as much as possible, the handling of patient samples. Interlaboratory comparison samples shall be examined by personnel who routinely examine patient samples using the same procedures as those used for patient samples. The laboratory shall not communicate with other participants in the interlaboratory comparison programme about sample data until after the date for submission of the data. The laboratory shall not refer interlaboratory comparison samples for confirmatory examinations before submission of the data, although this would routinely be done with patient samples.

5.6.3.4 Evaluation of laboratory performance

5.6.5 Amended When predetermined performance criteria are not fulfilled relevant staff, and not specifically laboratory management, are required to implement corrective actions and monitor the effectiveness of the actions taken.



Page 36 of 42 Medical Laboratory Accreditation Scheme- KENAS

New The performance in interlaboratory comparisons shall be reviewed and discussed with relevant staff.

5.6.4 Comparability of examination results

5.6.6, 5.6.7 New The laboratory shall notify users of any differences in comparability of results and discuss any implications for clinical practice when measuring systems provide different measurement intervals for the same measurand (e.g. glucose) and when examination methods are changed.

5.7 Post-examination processes 5.7.1 Review of results

5.7.1 Amended New

When the procedure for reviewing results involves automatic selection and reporting, review criteria shall be established, approved and documented.

The procedures for the review of examination results prior to release must also include evaluation of the results against internal quality control and previous examination results as appropriate.




5.7.2 Storage, retention and disposal of clinical samples

5.7.2, 5.7.3 New The laboratory shall have a documented procedure for identification, collection, retention, indexing, access, storage, maintenance and safe disposal of clinical samples. The laboratory shall define the length of time clinical samples are to be retained. Retention time shall be defined by the nature of the sample, the examination and any applicable requirements.

5.8 Reporting of results 5.8 5.8 Significant editorial Clause 5.8 in ISO 15189:2007 had

been separated into two clauses in the 2012 version, one covering the reporting of results and one covering the release of results.




5.8.1 General

5.8.1, 5.8.11, 5.8.12

Amended New

The results of each examination shall be reported accurately, clearly, unambiguously and in accordance with any specific instructions in the examination procedures. Reports shall include the information

The format, medium and the manner in which it is to be communicated is the responsibility of the laboratory. It is no longer specified that that it is the responsibility of laboratory management in discussion with the users of laboratory services. The laboratory is required to have a procedure to ensure correctness of any transcribed results, not just those from examinations performed by referral laboratories. The emphasis for notifying requesters when an examination result will be delayed is when the delay could compromise patient care.

5.8.2 Report attributes

5.8.3 k), 5.8.5 Significant editorial There is increased emphasis on ensuring report attributes effectively communicate laboratory results and meet the users‟ needs. The inclusion of detection limits and uncertainty




5.8.3 Report content

5.8.3 Amended It is now a requirement for any examinations that have been performed by a referral laboratory to be identified. Patient identification and location is to be included on each page. The date of sample collection is required on the report but the time is only required when available and relevant to patient care. The time of receipt into the laboratory is no longer a requirement. The identification of the person(s) New

Deleted

m) identification of examinations undertaken as part of a research or development programme and for which no claims on measurement performance are available. p) page number to total number of pages.

The signature or authorisation of the person checking or releasing the report, where possible, is no longer included as a requirement.




5.8.2 Deleted The shared responsibility of laboratory management with the requester to ensure reports are received by the appropriate individuals within an agreed-upon time interval is not 5.8.4 Deleted The recommendation to follow the vocabulary and syntax of listed organisations has been removed.

5.9 Release of results 5.9 Additional clause which

incorporates some clauses from 5.8 in the 2007 version and some additional requirements.

5.9.1 General

5.8.3, 5.8.5, 5.8.7, 5.8.9, 5.8.10, 5.8.13, 5.8.14

A number of sub-clauses have been consolidated into one clause.

5.9.2 Automated selection and reporting of results

New If the laboratory implements a system for automated selection and reporting of results, it shall establish a documented procedure to ensure that: a) - f)

A new clause covering requirements and criteria for automated selection and reporting of results.




5.9.3 Revised reports

5.8.15, 5.8.16 Amended A revised report must be clearly identified as such and must include reference to the date and patient‟s identity in the original report. In addition the user must be made aware of the revised report.

5.10 Laboratory information management 5.10 Annex B New Previously included as Annex B in

ISO 15189:2007 which was informative.

5.10.1 General

5.1.13 New The laboratory shall have access to the data and information needed to provide a service which meets the needs and requirements of the user.

5.10.2 Authorities and responsibilities

B.4 Editorial




5.10.3 Information system management

5.3.11, B2, B3, B5, B6, B7, B8

Amended New

When the information system(s) are managed and maintained off-site or subcontracted to an alternative provider, laboratory management shall be responsible for ensuring that the provider or operator of the system complies with all applicable requirements of this International Standard.

The laboratory is required to verify that all examinations results received into external information systems can be accurately reproduced. When a new examination or automated comment is implemented the laboratory is also required to verify that the changes are accurately reproduced.