This quality manual is prepared for New Civil Hospital Surat Laboratory Services, New Civil Hospital Surat as a compliance statement to NABL, India with reference to IS/ISO: 15189:2012 and NABL 112. The quality management system described in this quality manual applies to New Civil Hospital Surat Laboratory Services provided by Pathology, Microbiology and Biochemistry departments of New Civil Hospital Surat. This quality manual does not apply to laboratory services provided by other departments of New Civil Hospital Surat or examinations not under the scope of NABL, Gujarat India.

The following referenced documents are indispensable for the application of this document.

• ISO 15189:2012 part 1, IS/ISO, India
• ISO 15189:2012 part 2, IS/ISO, India
• ISO 15189:2012 part 3, IS/ISO, India
• ISO 15189:2012 part 4, IS/ISO, India
• 201905031045-nabl-112-effective-from-01.06.2019-doc.pdf
• 4161.pdf-clinical establisment act pdf file
• nabl-133.pdf Use of NABL Logo

3.1
accreditation
procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks

3.2
alert interval
critical interval
interval of examination results for an alert (critical) test that indicates an immediate risk to the patient of injury or death

NOTE 1 The interval may be open ended, where only a threshold is defined.
NOTE 2 The laboratory determines the appropriate list of alert tests for its patients and users.

3.3
automated selection and reporting of results
process by which patient examination results are sent to the laboratory information system and compared with laboratory-defined acceptance criteria, and in which results that fall within the defined criteria are automatically included in patient report formats without any additional intervention

3.4
biological reference interval
reference interval
specified interval of the distribution of values taken from a biological reference population

EXAMPLE
The central 95 % biological reference interval for sodium ion concentration values in serum from a population of presumed healthy male and female adults is 135 mmol/l to 145 mmol/l.
NOTE 1 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 A reference interval can depend upon the type of primary samples and the examination procedure used.
NOTE 3 In some cases, only one biological reference limit is important, for example, an upper limit, x, so that the corresponding biological reference interval would be less than or equal to x.
NOTE 4 Terms such as ‘normal range’, ‘normal values’, and ‘clinical range’ are ambiguous and therefore discouraged..

3.5
competence
demonstrated ability to apply knowledge and skills

NOTE The concept of competence is defined in a generic sense in this International Standard. The word usage can be more specific in other ISO documents.

3.6
documented procedure
specified way to carry out an activity or a process that is documented, implemented and maintained

NOTE 1 The requirement for a documented procedure may be addressed in a single document or by more than one document.
NOTE 2 Adapted from ISO 9000:2005, definition 3.4.5.

3.7
examination
set of operations having the object of determining the value or characteristics of a property

NOTE 1 In some disciplines (e.g. microbiology) an examination is the total activity of a number of tests, observations or measurements.
NOTE 2 Laboratory examinations that determine a value of a property are called quantitative examinations; those that determine the characteristics of a property are called qualitative examinations.
NOTE 3 Laboratory examinations are also often called assays or tests.

3.8
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions

3.9
laboratory director
person(s) with responsibility for, and authority over, a laboratory

NOTE 1 For the purposes of this International Standard, the person or persons referred to are designated collectively as laboratory director
NOTE 2 National, regional and local regulations may apply with regard to qualifications and training.
 3.10
laboratory management
person(s) who direct and manage the activities of a laboratory

NOTE The term ‘laboratory management’ is synonymous with the term ‘top management’ in ISO 9000:2005.

3.11
medical laboratory
clinical laboratory
laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological, biophysical, cytological, pathological, genetic or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, management, prevention and treatment of disease in, or assessment of the health of, human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation

NOTE These examinations also include procedures for determining, measuring or otherwise describing the presence or absence of various substances or microorganisms.

3.12
nonconformity
nonfulfillment of a requirement
[ISO 9000:2005, definition 3.6.2].

NOTE Other terms frequently used include: accident, adverse event, error, event, incident, and occurrence.

3.13
point-of-care testing
POCT
near-patient testing
testing performed near or at the site of a patient, with the result leading to possible change in the care of the patient [ISO 22870:2006, definition 3.1]

3.14
post-examination processes
postanalytical phase
processes following the examination including review of results, retention and storage of clinical material, sample (and waste) disposal, and formatting, releasing, reporting and retention of examination results

3.15
pre-examination processes
preanalytical phase
processes that start, in chronological order, from the clinician’s request and include the examination request, preparation and identification of the patient, collection of the primary sample(s), and transportation to and within the laboratory, and end when the analytical examination begins

3.16
primary sample
specimen
discrete portion of a body fluid, breath, hair or tissue taken for examination, study or analysis of one or more quantities or properties assumed to apply for the whole

NOTE 1 Global Harmonisation Task Force (GHTF) uses the term specimen in its harmonized guidance documents to mean a sample of biological origin intended for examination by a medical laboratory.
NOTE 2 In some ISO and CEN documents, a specimen is defined as “a biological sample derived from the human body”.
NOTE 3 In some countries, the term “specimen” is used instead of primary sample (or a subsample of it), which is the sample prepared for sending to, or as received by, the laboratory and which is intended for examination.

3.17
process
set of interrelated or interacting activities which transform inputs into outputs

NOTE 1 Inputs to a process are generally outputs of other processes.
NOTE 2 Adapted from ISO 9000:2005, definition 3.4.1.

3.18
quality
degree to which a set of inherent characteristics fulfills requirements

NOTE 1 The term “quality” can be used with adjectives such as poor, good or excellent.
NOTE 2 “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.
[ISO 9000:2005, definition 3.1.1]

3.19
quality indicator
measure of the degree to which a set of inherent characteristics fulfills requirements
NOTE 1 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 Quality indicators can measure how well an organization meets the needs and requirements of users and the quality of all operational processes.

EXAMPLE
If the requirement is to receive all urine samples in the laboratory uncontaminated, the number of contaminated urine samples received as a % of all urine samples received (the inherent characteristic of the process) is a measure of the quality of the process.

3.20
quality management system
management system to direct and control an organization with regard to quality

NOTE 1 The term “quality management system” referred to in this definition relates to general management activities, the provision and management of resources, the pre-examination, examination and post-examination processes and evaluation and continual improvement.
NOTE 2 Adapted from ISO 9000:2005, definition 3.2.3.

3.21
quality policy
overall intentions and direction of a laboratory related to quality as formally expressed by laboratory management

NOTE 1 Generally the quality policy is consistent with the overall policy of an organization and provides a framework for setting quality objectives.
NOTE 2 Adapted from ISO 9000:2005, definition 3.2.4

3.22
quality objective
something sought, or aimed for, related to quality

NOTE 1 Quality objectives are generally based on the laboratory’s quality policy.
NOTE 2 Quality objectives are generally specified for relevant functions and levels in the organization.
NOTE 3 Adapted from ISO 9000:2005, definition 3.2.5.

3.23
referral laboratory
external laboratory to which a sample is submitted for examination

NOTE A referral laboratory is one to which laboratory management chooses to submit a sample or sub-sample for examination or when routine examinations cannot be carried out. This differs from a laboratory that may include public health, forensics, tumour registry, or a central (parent) facility to which submission of samples is required by structure or regulation.

3.24
sample
one or more parts taken from a primary sample

EXAMPLE
A volume of serum taken from a larger volume of serum.

3.25
turnaround time
elapsed time between two specified points through pre-examination, examination and post-examination processes

3.26
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

NOTE 1 The term “validated” is used to designate the corresponding status.
NOTE 2 Adapted from ISO 9000:2005, definition 3.8.5.

3.27
verification
confirmation, through provision of objective evidence, that specified requirements have been fulfilled
NOTE 1 The term “verified” is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as

• performing alternative calculations,
• comparing a new design specification with a similar proven design specification,
• undertaking tests and demonstrations, and
• reviewing documents prior to issue.

The New Civil Hospital Surat Laboratory Services (hereinafter referred to as ‘the laboratory’) meets the requirements of ISO 15189:2012 when carrying out work at its permanent facilities, or in associated or mobile facilities.

The New Civil Hospital Surat of which the laboratory is part,is under administration of department of Health and Family welfare, Government of Gujarat.

The laboratory management ensures that the laboratory have procedure for personnel management which includes training of the personnel such that

1. personnel is not nvolved in any activities that would diminish confidence in the laboratory’s competence, impartiality, judgement or operational integrity.
2. personnel do not pressurize and influence anybody unduely commercially, financially, or otherwise that may adversely affect the quality of their work.
3. personnel openly and appropriately declare potential conflicts in competing interests that may exist.
4. personnel take appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements.
5. personnnel maintain confidentiality of information wherever relevent.

The Dean of the parent institute, also called chairman of the laboratory management committee, has delegated responsibility for the services provided by the laboratory to the laboratory director who is one of the teaching personnel of the department of pathology,microbiology and biochemistry. The laboratory director have the necessary competence, authority and resources in order to fulfil the requirements of ISO 15189 and NABL-112.
The responsibilities of the laboratory director includes professional, scientific, consultative or advisory, organizational, administrative and educational matters relevant to the services offered by the laboratory. The laboratory director delegates selected duties and/or responsibilities to qualified personnel from time to time; however, the laboratory director maintains the ultimate responsibility for the overall operation and administration of the laboratory.
The detailed duties and responsibilities of the laboratory director(and designate/s) includes

1. providing effective leadership of the medical laboratory service, including budget planning and financial management, in accordance with institutional assignment of such responsibilities.
2. relating and functioning effectively with applicable accrediting and regulatory agencies, appropriate administrative officials, the healthcare community, and the patient population served, and providers of formal agreements, when required.
3. ensuring that there are appropriate numbers of staff with the required education, training and competence to provide medical laboratory services that meet the needs and requirements of the users
4. ensureing the implementation of the quality policy.
5. implementing a safe laboratory environment in compliance with good practice and applicable requirements.
6. serving as a contributing member of the medical staff for those facilities served, if applicable and appropriate.
7. ensuring the provision of clinical advice with respect to the choice of examinations, use of the service and interpretation of examination results.
8. selecting and monitoring laboratory suppliers.
9. selecting referral laboratories and monitor the quality of their service.
10. providing professional development programmes for laboratory staff and opportunities to participate in
11. participating in scientific and other activities of professional laboratory organizations.
12. defining, implementing and monitoring standards of performance and quality improvement of the medical laboratory services. by participating in various quality improvement committees of the parent organization, as appropriate, where applicable.
13. monitoring all work performed in the laboratory to determine that clinically relevant information is being generated.
14. addressing any complaint, request or suggestion from staff and/or users of laboratory services.
15. designing and implementing a contingency plan to ensure that essential services are available during emergency situations or other conditions when laboratory services are limited or unavailable and periodically testing such plans.
16. planning and directing research and development, where appropriate.

Laboratory management is committed to the development and implementation of the quality management system and continually improves its effectiveness as evidenced by

1. Procedure for personnel management which includes training laboratory personnel to understand the importance of meeting the needs and requirements of users and the regulatory and accreditation requirements
2. established quality policy
3. established quality objectives
4. defined responsibilities, authorities and interrelationships of all personnel(see 4.1.2.5)
5. established communication processes(see 4.1.2.6)
6. appointment of quality manager(see 4.1.2.7)
7. conducted management review(see 4.15)
8. personnel competent to perform their assigned activities.(see 5.1.6)
9. adequate personnel(see 5.1) to enable the proper conduct of pre-examination, examination and post-examination activities
10. adequate Accommodation and environmental conditions(see 5.2) to enable the proper conduct of pre-examination, examination and post-examination activities
11. adequate Laboratory equipment, reagents, and consumables(see 5.3) to enable the proper conduct of pre-examination, examination and post-examination activities

Laboratory management ensures that laboratory services, including appropriate advisory and interpretative services, meet the needs of patients and those using the laboratory services as described at 4.4 of this manual and 4.14.3 of this manual

Laboratory management have define the intent of its quality management system in a quality policy. The management have ensured that the quality policy

1. is appropriate to the purpose of the organization
2. includes a commitment to good professional practice, examinations that are fit for intended use
3. compliance with the requirements of this International Standard, and continual improvement of the quality of laboratory services
4. provides a framework for establishing and reviewing quality objectives
5. is communicated and understood within the organization (see 5.1 Personnel)
6. is reviewed for continuing suitability



Laboratory management have establish quality objectives, including those needed to meet the needs and requirements of the users, at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy. Laboratory management has ensured that planning of the quality management system is carried out to meet the requirements of ISO 15189:2012 NABL-112 and the quality objectives. Laboratory management have ensured that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Laboratory management have ensured that responsibilities, authorities and interrelationships are defined, documented and communicated within the laboratory organization. This includes the appointment of person(s) responsible for each laboratory function and appointment of deputies for key managerial and technical personnel. One individual is given more than one function if it is found that it is impractical to appoint deputies for every function.

1. Laboratory Management Committee:The parent institute of the laboratory is a state government teaching college and hospital. Laboratory Management Comittee is formed by head of the institute for integreting laboratory service wide letter from office of the Dean GMC Surat
2. Chairman:The dean, head of the institute is also called chairman of the Laboratory Management Committee.
3. Co-chairman:The medical superintendent of the hospital is also called Co-chairman of the Laboratory Management Committee.
4. Laboratory Director:Responsibility and authority of laboratory director are described in section 4.1.1.4 Laboratory director of this manual.
5. Quality Manager:Responsibility and authority of quality manager are described in section 4.1.2.7 Quality manager of this manual.
6. Technical Manager:Technical manager is authorized and responsible for integrating day-to-day laboratory examination services across patholgoy, microbiology and biochemistry laboratory.Technical manager is also authorized and responsible for integrating day-to-day laboratory examination services with clinical departments of the parent institute.
7. Other responsibility and authority of all personnel are defined by the parent organization during recruitment.

Procedure for laboratory information management ensures that laboratory management have effective means for communicating with its personnel using various modes of communication which includes, but not limited to, verbal communications(e.g meetings), written communications (e.g circulars,letters) and electronic communications. Laboratory management ensures that appropriate communication processes are established between the laboratory and its stakeholders and that communication takes place regarding the effectiveness of the laboratory’s pre-examination, examination and post-examination processes and quality management system. Records of such communications are kept as required by rules and regulations of parent organization.

Laboratory management appoints one of the teaching personnel of department of pathology,microbiology and biochemistry as quality manager. Quality manager have, irrespective of other responsibilities, delegated responsibility and authority that includes:

1. ensuring that processes needed for the quality management system are established, implemented, and maintained
2. reporting to laboratory management, at the level at which decisions are made on laboratory policy, objectives, and resources, on the performance of the quality management system and any need for improvement
3. ensuring the promotion of awareness of users’ needs and requirements throughout the laboratory organization.

The laboratory establishes, documents, implements and maintains a quality management system and continually improve its effectiveness in accordance with the requirements of ISO 15189:2012 and NABL 112. The quality management system provides for the integration of all processes required to fulfill its quality policy and objectives and meet the needs and requirements of the users.

The resources necessary to support the operation and monitoring of these processes are described in figure-3. The quality management system ensures their availability by monitoring processes for their management.

Quality control process have three subprocesses

1. monitoring quality of other processes,
2. evaluating quality of other processes
3. implementing actions necessary to improve other processes.

In order to determine weather the operation and control of these processes are effective, the laboratory have developed various quality indicators. See 4.14.7 Quality indicators of this manual
In order to make sure that the operation and control of these processes are effective, the laboratory have developed procedures listed in section 6 of this manual and crossreferenced therein.

Following describe relationship of various procedures and processes requiring them. Each of the procedure may have subprocedures.

1. Pre-examination process
   1. Procedure for informing patients and users about the laboratory services
   2. Procedure for receiving examination request
   3. Procedure for primary sample collection and handling
   4. Procedure for sample transportation
   5. Procedure for receiving sample
   6. Procedure for pre-examination handling, preparation and storage
2. Examination process
   1. Procedure for selection, verification and validation of examination procedures
   2. Procedure for examination
3. Postexamination process
   1. Procedure for review of results
   2. Procedure for storage, retention and disposal of clinical samples
   3. Procedure for reporting of results
   4. Procedure for release of results
4. Human resource management process
   1. Procedure for personnel management
   2. Procedure for selecting and evaluating referral laboratories and consultants
5. Material resource management process
   1. Procedure for management of accommodation and environmental conditions
   2. Procedure for management of equipments
   3. Procedure for management of reagents and consumables
   4. Procedure for selecting and evaluating referral laboratories and consultants
6. Information resource management process
   1. Procedure for laboratory information management
7. Quality control process
   1. Document control procedure
   2. Procedure for control of records
   3. Procedure for evaluation, audits and resolution of complaints
   4. Procedure for identification, control, correction and prevention of nonconformities
   5. Procedure for management review
   6. Procedure for ensuring quality of examination results

The quality management system documentation includes at least following

1. quality policy and quality objectives
2. quality manual
3. procedures and documents and records required by ISO 15189:2012 and NABL-112 and and determined by the laboratory to ensure the effective planning, operation and control of its processes
4. Documents listed at section 2 Normative references of this manual.

1. Quality Manual (Top level document)
2. Quality Policy
3. Quality Objectives
4. c (C level documents)
   1. general (relevent to all department/section of the laboratory)
      1. documents
      2. records
   2. section/department XYZ (relevent to XYZ department/section of the laboratory)
      1. documents
      2. records

The laboratory have a quality manual that includes

1. reference to quality policy. Quality policy is made a saparate document for displaying it at various places of the laboratory with adequate document control. See 4.1.2.3 Quality policy
2. a description of the scope of the quality management system;See 1 Scope
3. a presentation of the organization and management structure of the laboratory and its place in any parent organization and a description of the roles and responsibilities of laboratory management (including the laboratory director and quality manager) for ensuring compliance with ISO 15189:2012 and NABL-112. See 4.1.2.5 Responsibility, authority and interrelationships
4. a description of the structure and relationships of the documentation used in the quality management system; see 4.2.2.1 Documentation requirements(General)
5. the documented policies established for the quality management system and reference to the managerial and technical activities that support them.(See all of section 4 and 5)
   

All laboratory staff have access to quality manual electronically at the NCHSLS server. Procedure for personnel management ensures that personnel are trained for the use and application of the quality manual and the referenced documents.

The laboratory controls documents required by the quality management system and ensures that unintended use of any obsolete document is prevented. The laboratory have document control procedure to ensure that the following conditions are met.

1. All documents, including those maintained in a computerized system, issued as part of the quality management system are reviewed and approved by authorized personnel before issue.
2. All documents are identified to include
   1. a title;
   2. a unique identifier on each page;
   3. the date of the current edition and/or edition number;
   4. page number to total number of pages (e.g. “Page 1 of 5,” “Page 2 of 5,”);
   5. authority for issue.
3. Current authorized editions and their distribution are identified by means of a list (e.g. document register, log or master index).
4. Only current, authorized editions of applicable documents are available at points of use.
5. Where a laboratory’s document control system allows for the amendment of documents by hand, pending the re-issue of documents, the procedures and authorities for such amendments are defined, amendments are clearly marked, initialled and dated, and a revised document is issued within a specified time period.
6. Changes to documents are identified.
7. Documents remain legible.
8. Documents are periodically reviewed and updated at a frequency that ensures that they remain fit for purpose.
9. Obsolete controlled documents are dated and marked as obsolete.
10. At least one copy of an obsolete controlled document is retained for a specified time period or in accordance with applicable specified requirements.

The laboratory have a documented Procedure for establishment and review of service agreements for providing medical laboratory services. Each request accepted by the laboratory for examination(s) is considered an agreement. Agreements to provide medical laboratory services takes into account the request, the examination and the report. The following conditions are met when the laboratory enters into an agreement to provide medical laboratory services.

1. The requirements of the customers and users, and of the provider of the laboratory services, including the examination processes to be used, are defined, documented and understood. see 5.4.2 Information for patients and users and 5.5 Examination processes of this manual
2. The agreement specifies the information needed on the request to ensure appropriate examination and result interpretation. see 5.4.3 Request form information of this manual.
3. The laboratory have the capability and resources to meet the requirements. see 5.1 Personnel, 5.2 Accommodation and environmental conditions, 5.3 Laboratory equipment, reagents, and consumables and 5.10 Laboratory information management of this manual.
4. Laboratory personnel have the skills and expertise necessary for the performance of the intended examinations see 5.1 Personnel of this manual.
5. Examination procedures selected are appropriate and able to meet the customers’ needs. See 5.5.1 Selection, verification and validation of examination procedures.
6. Customers and users are informed of deviations from the agreement that impact upon the examination results. See 5.8 Reporting of results of this manual.
7. Reference is made to any work referred by the laboratory to a referral laboratory or consultant. See 5.8 Reporting of results of this manual.

NOTE 1 Customers and users may include clinicians, health care organizations, third party payment organizations or agencies, pharmaceutical companies, and patients.
NOTE 2 Where patients are customers (e.g. when patients have the ability to directly request examinations), changes in service is reflected in explanatory information and laboratory reports.
NOTE 3 The Laboratory do not not enter into financial arrangements with referring practitioners or funding agencies where those arrangements act as an inducement for the referral of examinations or patients or interfere with the practitioner’s independent assessment of what is best for the patient.

Reviews of agreements to provide medical laboratory services includes all aspects of the agreement. Records of these reviews includes any changes to the agreement and any pertinent discussions. When an agreement needs to be amended after laboratory services have commenced, the same agreement review process is repeated and any amendments is communicated to all affected parties. Records of these reviews are included as special remarks in examination reports. See 5.8 Reporting of results of this manual.

The laboratory have a documented procedure for selecting and evaluating referral laboratories and consultants who provide opinions as well as interpretation for complex testing in any discipline. The procedure ensures that the following conditions are met.

1. The laboratory, with the advice of users of laboratory services where appropriate, is responsible for selecting the referral laboratory and referral consultants, monitoring the quality of performance and ensuring that the referral laboratories or referral consultants are competent to perform the requested examinations.
2. Arrangements with referral laboratories and consultants are reviewed and evaluated periodically to ensure that the relevant parts of ISO 15189:2013 and NABL-112 are met.
3. Records of such periodic reviews are maintained.
4. A register of all referral laboratories, and consultants from whom opinions are sought, is maintained.
5. Requests and results of all samples referred are kept for a pre-defined period.

Procedure for reporting of results ensures following.

1. Unless otherwise specified in the agreement, the referring laboratory (and not the referral laboratory) is responsible for ensuring that examination results of the referral laboratory are provided to the person making the request.
2. When the referring laboratory prepares the report, it includes all essential elements of the results reported by the referral laboratory or consultant, without alterations that could affect clinical interpretation.
3. The report indicates which examinations were performed by a referral laboratory or consultant.
4. The author of any additional remarks is clearly identified. Laboratories adopts the most appropriate means of reporting referral laboratory results, taking into account turnaround times, measurement accuracy, transcription processes and interpretative skill requirements.
5. In cases where the correct interpretation and application of examination results needs collaboration between clinicians and specialists from both referring and referral laboratories, this process is not hindered by commercial or financial considerations.

Procedure for management of accommodation and environmental conditions, Procedure for management of equipments and Procedure for management of reagents and consumables ensures that

1. the laboratory selects and approves suppliers based on their ability to supply external services, equipment, reagents and consumable supplies in accordance with the laboratory’s requirements.
2. it collaborates with parent organization to fulfill this requirement.
3. criteria for selection are established.
4. A list of selected and approved suppliers of equipment, reagents and consumables is maintained.
5. Purchasing information describes the requirements for the product or service to be purchased.
6. The laboratory monitors the performance of suppliers to ensure that purchased services or items consistently meet the stated criteria.

Procedure for informing patients and users about the laboratory services ensures

1. advise on choice of examinations and use of the services, including required type of sample
2. clinical indications and limitations of examination procedures and the frequency of requesting the examination
3. promoting the effective utilization of laboratory services

Procedure for reporting of results ensures

1. advising on individual clinical cases
2. generalized professional judgments on the interpretation of the results of examinations
3. consulting on scientific and logistic matters such as instances of failure of sample(s) to meet acceptance criteria

Procedure for evaluation, audits and resolution of complaints ensures that complains and feedback received from clinicians, patients, laboratory staff or other parties are investigated, action taken and recorded.

The laboratory have Procedure for identification, control, correction and prevention of nonconformities to identify and manage nonconformities in any aspect of the quality management system, including pre-examination, examination or post-examination processes. The procedure ensures that:

1. the responsibilities and authorities for handling nonconformities are designated;
2. the immediate actions to be taken are defined;
3. the extent of the nonconformity is determined;
4. examinations are halted and reports withheld as necessary;
5. the medical significance of any nonconforming examinations is considered and, where appropriate, the requesting clinician or authorized individual responsible for using the results is informed;
6. the results of any nonconforming or potentially nonconforming examinations already released are recalled or appropriately identified, as necessary;
7. the responsibility for authorization of the resumption of examinations is defined;
8. each episode of nonconformity is documented and recorded, with these records being reviewed at regular specified intervals to detect trends and initiate corrective action.
   

NOTE: Nonconforming examinations or activities occur in many different areas and can be identified in many different ways, including clinician complaints, internal quality control indications, instrument calibrations, checking of consumable materials, interlaboratory comparisons, staff comments, reporting and certificate checking, laboratory management reviews, and internal and external audits.
When it is determined that nonconformities in pre-examination, examination and post-examination processes could recur or that there is doubt about the laboratory’s compliance with its own procedures, the laboratory takes action to identify, document and eliminate the cause(s). Corrective action to be taken is determined and recorded as explained in next section

The laboratory have Procedure for identification, control, correction and prevention of nonconformities to take corrective action to eliminate the cause(s) of nonconformities. Corrective actions are appropriate to the effects of the nonconformities encountered. The procedure

1. reviews nonconformities;
2. determines the root causes of nonconformities;
3. evaluates the need for corrective action to ensure that nonconformities do not recur;
4. determine and implement corrective action needed;
5. record the results of corrective action taken
6. reviews the effectiveness of the corrective action taken

NOTE: Action taken at the time of the nonconformity to mitigate its immediate effects is considered “immediate” action. Only action taken to remove the root cause of the problem that is causing the conconformities is considered “corrective” action.

The laboratory have Procedure for identification, control, correction and prevention of nonconformities to determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. The procedure

1. reviews laboratory data and information to determine where potential nonconformities exist;
2. determine the root cause(s) of potential nonconformities;
3. evaluate the need for preventive action to prevent the occurrence of nonconformities;
4. determine and implement preventive action needed;
5. record the results of preventive action taken
6. review the effectiveness of the preventive action taken.

NOTE: Preventive action is a proactive process for identifying opportunities for improvement rather than a reaction to the identification of problems or complaints (i.e. nonconformities). In addition to review of the operational procedures, preventive action might involve analysis of data, including trend and risk analyses and external quality assessment (proficiency testing).

The laboratory continually improves the effectiveness of the quality management system, including the pre-examination, examination and post-examination processes, through the use of Procedure for management review which

1. compares the laboratory’s actual performance in its evaluation activities
2. compares corrective actions and preventive actions with its intentions, as stated in the quality policy and quality objectives.
3. directs improvement activities at areas of highest priority based on risk assessments.
4. develops,documents and implements action plans for improvement, as appropriate.
5. monitors the effectiveness of the actions taken through a focused review or audit of the area concerned determined. see also 4.14.5 Internal audit.
6. ensures that the laboratory participates in continual improvement activities that encompass relevant areas and outcomes of patient care.
7. identifies opportunities for improvement, regardless of where the occur.
8. communicates to staff improvement plans and related goals.

Procedure for control of records ensures that identification, collection, indexing, access, storage, maintenance, amendment and safe disposal of quality and technical records occure in such a way that

1. They are created concurrently with performance of each activity that affects the quality of the examination.
2. The date and, where relevant, the time of amendments to records is captured along with the identity of personnel making the amendments (see 5.8.6)
3. Records pertaining to the quality management system, including pre-examination, examination and post-examination processes, are retained as long as medically relevant or as required by regulation. Legal liability concerns regarding certain types of procedures (e.g. histology examinations, genetic examinations, paediatric examinations) may require the retention of certain records for much longer periods than for other records.
4. They are readily accessible and protected from unauthorized alterations
5. They are stored in ways that prevent damage, deterioration, loss or unauthorized access (see 5.2.6). For some records, especially those stored electronically, the safest storage is on secure media and an offsite location (see 5.9.4).
6. All of these quality and technical records are available for laboratory management review (see 4.15).

Records include, at least, the following:

1. Pre-examination process
   1. request for examination
   2. records of receipt of samples in the laboratory
2. Examination process
   1. laboratory work books or work sheets
   2. instrument printouts and retained data and information
   3. calibration functions and conversion factors
3. Postexamination process
   1. examination results and reports
4. Human resource management process
   1. staff qualifications, training and competency records;
5. Material resource management process
   1. supplier selection and performance, and changes to the approved supplier list
   2. information on reagents and materials used for examinations (e.g. lot documentation, certificates of supplies, package inserts)
   3. instrument maintenance records, including internal and external calibration records
6. Quality control process
   1. quality control records
   2. incident records and action taken
   3. accident records and action taken
   4. risk management records
   5. nonconformities identified and immediate or corrective action taken
   6. preventive action taken
   7. complaints and action taken
   8. records of internal and external audits
   9. interlaboratory comparisons of examination results
   10. records of quality improvement activities
   11. minutes of meetings that record decisions made about the laboratory’s quality management activities
   12. records of management reviews

Procedure for evaluation, audits and resolution of complaints ensures that the laboratory plan and implement the evaluation and internal audit processes needed to:

1. demonstrate that the pre-examination, examination and post-examination and supporting processes are being conducted in a manner that meets the needs and requirements of users
2. ensure conformity to the quality management system
3. continually improve the effectiveness of the quality management system.

The results of evaluation and improvement activities are included in the input to the management review (see 4.15 Management review).
NOTE For improvement activities, see 4.10 Corrective action, 4.11 Preventive action, 4.12 Continual improvement

Procedure for receiving examination request ensures that authorized personnel periodically reviews the examinations provided by the laboratory so that they are clinically appropriate for the requests received.
Procedure for primary sample collection and handling ensures that the laboratory periodically reviews 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.

Procedure for evaluation, audits and resolution of complaints ensures that

1. the laboratory seeks 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 includes cooperation with users or their representatives in monitoring the laboratory’s performance, provided that the laboratory ensures confidentiality to other users.
2. records are kept of information collected and actions taken.

Procedure for evaluation, audits and resolution of complaints ensures that

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

Procedure for evaluation, audits and resolution of complaints ensures that the laboratory conducts internal audits at planned intervals to determine whether all activities in the quality management system, including pre-examination, examination, and post-examination:

1. conform to the requirements of ISO 15189:2012, NABL-112 and to requirements established by the laboratory, and
2. are implemented, effective, and maintained.

NOTE 1 The cycle for internal auditing should normally be completed in one year. It is not necessary that internal audits cover each year, in depth, all elements of the quality management system. The laboratory may decide to focus on a particular activity without completely neglecting the others. Audits are conducted by personnel trained to assess the performance of managerial and technical processes of the quality management system. The audit programme takes into account the status and importance of the processes and technical and management areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined and documented. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors are, wherever resources permit, independent of the activity to be audited.
NOTE 2 See ISO 19011 for guidance. The procedure ensures that the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined . Personnel responsible for the area being audited ensures that appropriate action is promptly undertaken when nonconformities are identified. Corrective action re taken without undue delay to eliminate the causes of the detected nonconformities.

Procedure for identification, control, correction and prevention of nonconformities ensures that the laboratory evaluates 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.

Procedure for monitoring quality indicators developed by the laboratory identifies quality indicators to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes.EXAMPLE:Number of unacceptable samples, number of errors at registration and/or accession, number of corrected reports. The process of monitoring quality indicators is planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement. The indicators are periodically reviewed, to ensure their continued appropriateness.
NOTE 1 Quality indicators to monitor non-examination procedures, such as laboratory safety and environment, completeness of equipment and personnel records, and effectiveness of the document control system may provide valuable management insights.
NOTE 2 The laboratory establishes quality indicators for systematically monitoring and evaluating the laboratory’s contribution to patient care (see 4.12). The laboratory, in consultation with the users, establishes turnaround times for each of its examinations that reflect clinical needs. The laboratory periodically evaluates whether or not it is meeting the established turnaround times.

Procedure for evaluation, audits and resolution of complaints ensures that when reviews by external organizations indicate the laboratory has nonconformities or potential nonconformities, the laboratory take appropriate immediate actions and, as appropriate, corrective action or preventive action to ensure continuing compliance with the requirements of ISO 15189:2012 and NABL-112. Records are kept of the reviews and of the corrective actions and preventive actions taken.
NOTE Examples of reviews by external accreditation organizations include: accreditation assessments, regulatory agencies’ inspections, and health and safety inspections.

Procedure for management review ensures that the management is involved in maintaining laboratory's continuing suitability, adequacy and effectiveness and in giving appropriate support of patient care.

The input to management review includes information from the results of evaluations of at least the following:

1. the periodic review of requests, and suitability of procedures and sample requirements
2. assessment of user feedback
3. staff suggestions
4. internal audits
5. risk management
6. use of quality indicators
7. reviews by external organizations
8. results of participation in interlaboratory comparison programmes (PT/EQA)
9. monitoring and resolution of complaints
10. performance of suppliers
11. identification and control of nonconformities
12. results of continual improvement including current status of corrective actions and preventive actions
13. follow-up actions from previous management reviews
14. changes in the volume and scope of work, personnel, and premises that could affect the quality management system
15. recommendations for improvement, including technical requirements.

The review analyses the input information for causes of nonconformities, trends and patterns that indicate process problems. This review includes assessing these opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. The quality and appropriateness of the laboratory’s contribution to patient care , to the extent possible, also is objectively evaluated.

The output from the management review is incorporated into a record that documents any decisions made and actions taken during management review related to:

1. improvement of the effectiveness of the quality management system and its processes
2. improvement of services to users
3. resource needs

NOTE: The interval between management reviews is no greater than 12 months; however, shorter intervals is adopted when a quality management system is being established. Findings and actions arising from management reviews are recorded and reported to laboratory staff. Laboratory management ensures that actions arising from management review are completed within a defined timeframe.

Procedure for personnel management ensures that personnel management and its records comply with the requirements of ISO 15189:2012 and NABL-112.

Laboratory management documents personnel qualifications for each position. The qualifications reflects the appropriate education, training, experience and demonstrated skills needed, and be appropriate to the tasks performed. The personnel making judgments with reference to examinations have the applicable theoretical and practical background and experience.
NOTE: Professional judgements can be expressed as opinions, interpretations, predictions, simulations and models and values, and should be in accordance with national, regional and local regulations and professional guidelines.

The laboratory have job descriptions that describe responsibilities, authorities and tasks for all personnel.

The laboratory have a programme to introduce new staff 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 (including fire and emergency), and occupational health services.

The laboratory provides training for all personnel which includes the following areas:

1. the quality management system;
2. assigned work processes and procedures;
3. the applicable laboratory information system;
4. health and safety, including the prevention or containment of the effects of adverse incidents;
5. ethics;
6. confidentiality of patient information.

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

Following appropriate training, the laboratory assesses the competence of each person to perform assigned managerial or technical tasks according to established criteria. Reassessment takes place at regular intervals. Retraining occurs when necessary.
NOTE 1: Competence of laboratory staff is assessed by using any combination or all of the following approaches under the same conditions as the general working environment:

1. direct observation of routine work processes and procedures, including all applicable safety practices;
2. direct observation of equipment maintenance and function checks;
3. monitoring the recording and reporting of examination results;
4. review of work records;
5. assessment of problem solving skills;
6. examination of specially provided samples, such as previously examined samples, interlaboratory comparison materials, or split samples.

NOTE 2: Competency assessment for professional judgment is designed as specific and fit for purpose.

In addition to the assessment of technical competence, the laboratory ensures that reviews of staff performance consider the needs of the laboratory and of the individual in order to maintain or improve the quality of service given to the users and encourage productive working relationships. NOTE: Staff performing reviews receives appropriate training.

A continuing education programme is available to personnel who participate in managerial and technical processes. Personnel takes part in continuing education. The effectiveness of the continuing education programme is periodically reviewed. Personnel takes part in regular professional development or other professional liaison activities.

Records of the relevant educational and professional qualifications, training and experience, and assessments of competence of all personnel are maintained. These records are readily available to relevant personnel and includes but not be limited to:

1. educational and professional qualifications;
2. copy of certification or license, when applicable;
3. previous work experience;
4. job descriptions;
5. introduction of new staff to the laboratory environment;
6. training in current job tasks;
7. competency assessments;
8. records of continuing education and achievements;
9. reviews of staff performance;
10. reports of accidents and exposure to occupational hazards;
11. immunisation status, when relevant to assigned duties.

NOTE: The records listed above are not required to be stored in the laboratory, but can be maintained in other specified locations, providing they remain accessible as needed.

Procedure for management of accommodation and environmental conditions ensures following.

The laboratory have space allocated for the performance of its work that is designed to ensure the quality, safety and efficacy of the service provided to the users and the health and safety of laboratory personnel, patients and visitors. The laboratory evaluates and determines the sufficiency and adequacy of the space allocated for the performance of the work. Where applicable, similar provisions is made for primary sample collection and examinations at sites other than the main laboratory premises, for example point-of-care testing (POCT) under the management of the laboratory.

The laboratory and associated office facilities provides an environment suitable for the tasks to be undertaken, to ensure the following conditions are met.

1. Access to areas affecting the quality of examinations is controlled.NOTE: Access control takes into consideration safety, confidentiality, quality and prevailing practices.
2. Medical information, patient samples, and laboratory resources are safeguarded from unauthorized access.
3. Facilities for examination allow for correct performance of examinations. These include, for example, energy sources, lighting, ventilation, noise, water, waste disposal and environmental conditions.
4. Communication systems within the laboratory are appropriate to the size and complexity of the facility to ensure the efficient transfer of information.
5. Safety facilities and devices are provided and their functioning regularly verified.EXAMPLE: Operation of emergency release, intercom and alarm systems for cold rooms and walk-in freezers; accessibility of emergency showers and eyewash, etc.
6. clinical_lab_maintenece_sheet.ods

Storage space and conditions are provided that ensure the continuing integrity of sample materials, documents, equipment, reagents, consumables, records, results and any other items that could affect the quality of examination results. Clinical samples and materials used in examination processes are stored in a manner to prevent cross contamination. Storage and disposal facilities for dangerous materials is appropriate to the hazards of the materials and as specified by applicable requirements.

There is adequate access to washrooms, to a supply of drinking water and to facilities for storage of personal protective equipment and clothing.NOTE: When possible, the laboratory provides space for staff activities such as meetings and quiet study and a rest area.

Patient sample collection facilities have separate reception/waiting and collection areas. Consideration is given to the accommodation of patient privacy, comfort and needs (e.g. disabled access, toilet facility) and accommodation of appropriate accompanying person (e.g. guardian or interpreter) during collection. Facilities at which patient sample collection procedures are performed (e.g. phlebotomy) enables the sample collection to be undertaken in a manner that does not invalidate the results or adversely affect the quality of the examination. Sample collection facilities have and maintain appropriate first aid materials for both patient and staff needs.NOTE: Some facilities may need equipment appropriate for resuscitation; local regulations may apply.

Laboratory premises are maintained in a functional and reliable condition. Work areas are clean and well maintained. The laboratory monitors, controls and records environmental conditions, as required by relevant specifications or where they may influence the quality of the sample, results, and/or the health of staff. Attention is paid to factors such as light, sterility, dust, noxious or hazardous fumes, electromagnetic interference, radiation, humidity, electrical supply, temperature, sound and vibration levels and workflow logistics, as appropriate to the activities concerned so that these do not invalidate the results or adversely affect the required quality of any examination. There is effective separation between laboratory sections in which there are incompatible activities. Procedures are in place to prevent cross-contamination where examination procedures pose a hazard or where work could be affected or influenced by not being separated. The laboratory provides a quiet and uninterrupted work environment where it is needed.NOTE: Examples of a quiet and uninterrupted work area include cytopathology screening, microscopic differentiation of blood cells and microorganisms, data analysis from sequencing reactions and review of molecular mutations results.

NOTE 1: For the purposes of this International Standard, laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems.
NOTE 2: Reagents include reference materials, calibrators and quality control materials; consumables include culture media, pipette tips, glass slides, etc.
NOTE 3: See 4.6 External services and supplies for information concerning the selection and purchasing of external services, equipment, reagents and consumables.

Procedure for management of equipments ensures selection, purchasing and management of equipment appropriate to the quality policy and objectives. The laboratory is furnished with all equipment needed for the provision of services (including primary sample collection, sample preparation, sample processing, examination and storage). In those cases where the laboratory needs to use equipment outside its permanent control, laboratory management ensures that the requirements of ISO 15189:2012 and NABL-112 are met. The laboratory replaces equipment as needed to ensure the quality of examination results.

The laboratory verifies upon installation and before use that the equipment is capable of achieving the necessary performance and that it complies with requirements relevant to any examinations concerned (see also 5.5.1 Selection, verification and validation of examination procedures).NOTE: This requirement applies to: equipment used in the laboratory, equipment on loan or equipment used in associated or mobile facilities by others authorized by the laboratory. Each item of equipment is uniquely labelled, marked or otherwise identified.

Equipment is operated at all times by trained and authorized personnel. Current instructions on the use, safety and maintenance of equipment, including any relevant manuals and directions for use provided by the manufacturer of the equipment, is readily available. The laboratory have procedures for safe handling, transport, storage and use of equipment to prevent its contamination or deterioration.

The laboratory have a documented procedure for the calibration of equipment that directly or indirectly affects examination results. This procedure includes:

1. taking into account conditions of use and the manufacturer’s instructions;
2. recording the metrological traceability of the calibration standard and the traceable calibration of the item of equipment;
3. verifying the required measurement accuracy and the functioning of the measuring system at defined intervals;
4. recording the calibration status and date of recalibration;
5. ensuring that, where calibration gives rise to a set of correction factors, the previous calibration factors are correctly updated;
6. safeguards to prevent adjustments or tampering that might invalidate examination results.
7. Metrological traceability is to a reference material or reference procedure of the higher metrological order available.NOTE: Documentation of calibration traceability to a higher order reference material or reference procedure may be provided by an examination system manufacturer. Such documentation is acceptable as long as the manufacturer’s examination system and calibration procedures are used without modification. Where this is not possible or relevant, other means for providing confidence in the results shall be applied, including but not limited to the following:
   1. use of certified reference materials;
   2. examination or calibration by another procedure;
   3. mutual consent standards or methods which are clearly established, specified, characterized and mutually agreed upon by all parties concerned.

The laboratory have a documented programme of preventive maintenance which, at a minimum, follows the manufacturer’s instructions. Equipment is maintained in a safe working condition and in working order. This includes examination of electrical safety, emergency stop devices where they exist and the safe handling and disposal of chemical, radioactive and biological materials by authorized persons. At a minimum, manufacturer’s schedules or instructions, or both, shall be used. Whenever equipment is found to be defective, it is taken out of service and clearly labelled. The laboratory ensures that defective equipment is not used until it has been repaired and shown by verification to meet specified acceptance criteria. The laboratory examines the effect of any defects on previous examinations and institute immediate action or corrective action. The laboratory takes reasonable measures to decontaminate equipment before service, repair or decommissioning, provide suitable space for repairs and provide appropriate personal protective equipment. When equipment is removed from the direct control of the laboratory, the laboratory ensures that its performance is verified before being returned to laboratory use.

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

Records are maintained for each item of equipment that contributes to the performance of examinations. These equipment records includes, but not be limited to, the following:

1. identity of the equipment;
2. manufacturer’s name, model and serial number or other unique identification;
3. contact information for the supplier or the manufacturer;
4. date of receiving and date of entering into service;
5. location;
6. condition when received (e.g. new, used or reconditioned);
7. manufacturer’s instructions;
8. records that confirmed the equipment’s initial acceptability for use when equipment is incorporated in the laboratory;
9. maintenance carried out and the schedule for preventive maintenance;
10. equipment performance records that confirm the equipment’s ongoing acceptability for use;Such records include copies of reports/certificates of all calibrations and/or verifications including dates, times and results, adjustments, the acceptance criteria and due date of the next calibration and/or verification, to fulfil part or all of ISO 15189:2012 and NABL-112.
11. damage to, or malfunction, modification, or repair of the equipment.

These records are maintained and are readily available for the lifespan of the equipment or longer, as specified in the laboratory’s Procedure for control of records.

The laboratory have procedure for management of reagents and consumables for the reception, storage, acceptance testing and inventory management of reagents and consumables.

The receiving location of the laboratory has adequate storage and handling capabilities to maintain purchased items in a manner that prevents damage or deterioration. The laboratory stores received reagents and consumables according to manufacturer’s specifications.

Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, is verified for performance before use in examinations. Consumables that can affect the quality of examinations are verified for performance before use in examinations.

The laboratory has established an inventory control system for reagents and consumables. The system for inventory control segregates uninspected and unacceptable reagents and consumables from those that have been accepted for use.

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

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

Records are maintained for each reagent and consumable that contributes to the performance of examinations. These records includes but not be limited to the following:

1. identity of the reagent or consumable;
2. manufacturer’s name and batch code or lot number;
3. contact information for the supplier or the manufacturer;
4. date of receiving, the expiry date, date of entering into service and, where applicable, the date the material was taken out of service;
5. condition when received (e.g. acceptable or damaged);
6. manufacturer’s instructions;
7. records that confirmed the reagent’s or consumable’s initial acceptance for use;
8. performance records that confirm the reagent’s or consumable’s ongoing acceptance for use. Where the laboratory uses reagents prepared or completed in-house, the records includes, in addition to the relevant information above, reference to the person or persons undertaking their preparation and the date of preparation.

The laboratory have documented procedures and information for pre-examination activities to ensure the validity of the results of examinations. The pre-examination process of the laboratory is explained below.

Note:Only processes carried out by NCHSLS is controlled. For processes done by non-NCHSLS personnel,only end result of process is monitored when their output is received by NCHSLS.

Procedure for informing patients and users about the laboratory services ensures that the laboratory have information available for patients and users of the laboratory services. The information includes as appropriate:

1. the location of the laboratory;
2. types of clinical services offered by the laboratory including examinations referred to other laboratories;
3. opening hours of the laboratory;
4. the examinations offered by the laboratory including, as appropriate, information concerning samples required, primary sample volumes, special precautions, turnaround time, (which may also be provided in general categories or for groups of examinations), biological reference intervals, and clinical decision values;
5. instructions for completion of the request form;
6. instruction for preparation of the patient;
7. instructions for patient-collected samples;
8. instructions for transportation of samples, including any special handling needs;
9. any requirements for patient consent (e.g. consent to disclose clinical information and family history to relevant healthcare professionals, where referral is needed);
10. the laboratory’s criteria for accepting and rejecting samples;
11. a list of factors known to significantly affect the performance of the examination or the interpretation of the results;
12. availability of clinical advice on ordering of examinations and on interpretation of examination results;
13. the laboratory’s policy on protection of personal information;
14. the laboratory’s complaint procedure.
15. information for patients and users that includes an explanation of the clinical procedure to be performed to enable informed consent. Importance of provision of patient and family information, where relevant (e.g. for interpreting genetic examination results), shall be explained to the patient and user.

Procedure for receiving examination request ensures that the request form or an electronic equivalent allows space for the inclusion of, but not be limited to, the following:

1. patient identification, including gender, date of birth, and the location/contact details of the patient, and a unique identifier;NOTE: Unique identification includes an alpha and/or numerical identifier such as a hospital number, or personal health number.
2. name or other unique identifier of clinician, healthcare provider, or other person legally authorized to request examinations or use medical information, together with the destination for the report and contact details;
3. type of primary sample and, where relevant, the anatomic site of origin;
4. examinations requested;
5. clinically relevant information about the patient and the request, for examination performance and result interpretation purposes;NOTE: Information needed for examination performance and results interpretation may include the patient’s ancestry, family history, travel and exposure history, communicable diseases and other clinically relevant information. Financial information for billing purposes, financial audit, resource management and utilization reviews may also be collected. The patient is made aware of the information collected and the purpose for which it is collected.
6. date and, where relevant, time of primary sample collection;
7. date and time of sample receipt.

NOTE: The format of the request form (e.g. electronic or paper) and the manner in which requests are to be communicated to the laboratory are determined in discussion with the users of laboratory services.The procedure also includes method for verbal requests for examinations that includes providing confirmation by request form or electronic equivalent within a given time. The laboratory is willing to cooperate with users or their representatives in clarifying the user’s request.

Procedure for primary sample collection and handling ensures proper collection and handling of primary samples. Required instructions for primary sample collection and handling are made available to those responsible for primary sample collection whether or not the collectors are laboratory staff. Where the user requires deviations and exclusions from, or additions to, the documented collection procedure, these are recorded and included in all documents containing examination results and is communicated to the appropriate personnel.
NOTE 1: All procedures carried out on a patient after taking the informed consent of the patient. For most routine laboratory procedures, consent is inferred when the patient presents himself or herself at a laboratory with a request form and willingly submits to the usual collecting procedure, for example, venipuncture. Patients in a hospital bed is normally given the opportunity to refuse. Special procedures, including more invasive procedures, or those with an increased risk of complications to the procedure, is explained in detail, and in some cases, written consent is taken. In emergency situations, consent might not be possible; under these circumstances necessary procedures are carried out, provided they are in the patient’s best interest.
NOTE 2: Adequate privacy during reception and sampling is available and appropriate to the type of information being requested and primary sample being collected.

Procedure for primary sample collection and handling ensures that the laboratory prepares instructions for pre-collection activities which includes the following:

1. completion of request form or electronic request;
2. preparation of the patient (e.g. instructions to caregivers, phlebotomists, sample collectors and patients);
3. type and amount of the primary sample to be collected with descriptions of the primary sample containers and any necessary additives;
4. special timing of collection, where needed;
5. clinical information relevant to or affecting sample collection, examination performance or result interpretation (e.g. history of administration of drugs).

Procedure for primary sample collection and handling ensures that the laboratory prepares instructions for collection activities which includes the following:

1. determination of the identity of the patient from whom a primary sample is collected;
2. verification that the patient meets pre-examination requirements [e.g. fasting status, medication status (time of last dose, cessation), sample collection at predetermined time or time intervals, etc.];
3. instructions for collection of primary blood and non-blood samples, with descriptions of the primary sample containers and any necessary additives;
4. 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 is determined and communicated to the appropriate clinical staff;
5. instructions for labelling of primary samples in a manner that provides an unequivocal link with the patients from whom they are collected;
6. recording of the identity of the person collecting the primary sample and the collection date, and, when needed, recording of the collection time;
7. instructions for proper storage conditions before collected samples are delivered to the laboratory;
8. safe disposal of materials used in the collection.

Procedure for sample transportation ensures that the laboratory provides instructions for post-collection activities includes packaging of samples for transportation. The procedure also monitors the transportations of samples to ensure they are transported:

1. within a time frame appropriate to the nature of the requested examinations and the laboratory discipline concerned;
2. within a temperature interval specified for sample collection and handling and with the designated preservatives to ensure the integrity of samples;
3. in a manner that ensures the integrity of the sample and the safety for the carrier, the general public and the receiving laboratory, in compliance with established requirements.
   

NOTE: The laboratory is not involved in primary sample collection and transportation of sample received from all places other than OPD. Upon receipt of such samples whose integrity was compromised or which could have jeopardized the safety of the carrier or the general public, the sender is contacted immediately and informed about measures to be taken to eliminate recurrence.

The laboratory’s procedure for sample reception ensures that the following conditions are met.

1. Samples are unequivocally traceable, by request and labelling, to an identified patient or site.
2. Laboratory-developed and documented criteria for acceptance or rejection of samples are applied.
3. Where there are problems with patient or sample identification, sample instability due to delay in transport or inappropriate container(s), insufficient sample volume, or when the sample is clinically critical or irreplaceable and the laboratory chooses to process the sample, the final report indicates the nature of the problem and, where applicable, that caution is required when interpreting the result.
4. All samples received are recorded in an accession book, worksheet, computer or other comparable system. The date and time of receipt and/or registration of samples is recorded. Whenever possible, the identity of the person receiving the sample is also recorded.
5. Authorized personnel evaluates received samples to ensure that they meet the acceptance criteria relevant for the requested examination(s).
6. Where relevant, there are instructions for the receipt, labelling, processing and reporting of samples specifically marked as urgent. The instructions includes details of any special labelling of the request form and sample, the mechanism of transfer of the sample to the examination area of the laboratory, any rapid processing mode to be used, and any special reporting criteria to be followed.
7. All portions of the primary sample are unequivocally traceable to the original primary sample.

Procedure for pre-examination handling, preparation and storage for securing patient samples and avoiding deterioration, loss or damage during pre-examination activities and during handling, preparation and storage.Various procedures for Material resource management process(see 4.2 Quality management system) of material resources ensures that the laboratory facilities are adequate for securing patient samples and avoiding deterioration, loss or damage during pre-examination activities and during handling, preparation and storage. Procedures for examination includes time limits for requesting additional examinations or further examinations on the same primary sample.

Procedure for selection, verification and validation of examination procedures ensures following.

The laboratory selects examination procedures which have been validated for their intended use. The identity of persons performing activities in examination processes is recorded. The specified requirements (performance specifications) for each examination procedure relates to the intended use of that examination.NOTE: Preferred procedures are those specified in the instructions for use of in vitro medical devices or those that have been published in established/authoritative textbooks, peer-reviewed texts or journals, or in international consensus standards or guidelines, or national or regional regulations.

Validated examination procedures used without modification are subject to independent verification by the laboratory before being introduced into routine use. The laboratory obtains information from the manufacturer/method developer for confirming the performance characteristics of the procedure. The independent verification by the laboratory confirms, through obtaining objective evidence (in the form of performance characteristics) that the performance claims for the examination procedure have been met. The performance claims for the examination procedure confirmed during the verification process are those relevant to the intended use of the examination results. The laboratory documents the procedure used for the verification and record the results obtained. Staff with the appropriate authority reviews the verification results and record the review.

The laboratory validates examination procedures derived from the following sources:

1. non-standard methods;
2. laboratory designed or developed methods;
3. standard methods used outside their intended scope;
4. validated methods subsequently modified.

The validation is as extensive as is necessary and confirm, through the provision of objective evidence (in the form of performance characteristics), that the specific requirements for the intended use of the examination have been fulfilled.NOTE: Performance characteristics of an examination procedure includes consideration of: measurement trueness, measurement accuracy, measurement precision including measurement repeatability and measurement intermediate precision; measurement uncertainty, analytical specificity, including interfering substances, analytical sensitivity, detection limit and quantitation limit, measuring interval, diagnostic specificity and diagnostic sensitivity. The laboratory documents the procedure used for the validation and record the results obtained. Staff with the authority reviews the validation results and record the review. When changes are made to a validated examination procedure, the influence of such changes are documented and, when appropriate, a new validation is carried out.

The laboratory determines measurement uncertainty for each measurement procedure in the examination phase used to report measured quantity values on patients’ samples. The laboratory defines the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.
NOTE 1: The relevant uncertainty components are those associated with the actual measurement process, commencing with the presentation of the sample to the measurement procedure and ending with the output of the measured value.
NOTE 2: Measurement uncertainties may be calculated using quantity values obtained by the measurement of quality control materials under intermediate precision conditions that include as many routine changes as reasonably possible in the standard operation of a measurement procedure, e.g. changes of reagent and calibrator batches, different operators, scheduled instrument maintenance.
NOTE 3: Examples of the practical utility of measurement uncertainty estimates might include confirmation that patients’ values meet quality goals set by the laboratory and meaningful comparison of a patient value with a previous value of the same type or with a clinical decision value.
The laboratory considers measurement uncertainty when interpreting measured quantity values. Upon request, the laboratory makes its estimates of measurement uncertainty available to laboratory users. Where examinations include a measurement step but do not report a measured quantity value, the laboratory calculates 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.

bipm-jcgm-100-2008-e-gum-evaluation-of-measurement-data-guide-to-the-expression-of-uncertainty-in-measurement.pdf

• TRUENESS, ACCURACY AND PRECISION

Procedures for examination ensures that the biological reference intervals or clinical decision values, are defined, documents the basis for the reference intervals or decision values and communicate this information to users. When a particular biological reference interval or decision value is no longer relevant for the population served, appropriate changes are made and communicated to the users. When the laboratory changes an examination procedure or pre-examination procedure, the laboratory reviews associated reference intervals and clinical decision values, as applicable.

Procedures for examination are written in a language commonly understood by the staff in the laboratory and are available in appropriate locations. Any condensed document format (e.g. card files or similarly used systems) correspond to the documented procedure.
NOTE 1: Working instructions, card files or similar systems that summarize key information are acceptable for use as a quick reference at the workbench, provided that a full documented procedure is available for reference. NOTE 2: Information from product instructions for use is incorporated into examination procedures by reference. All documents that are associated with the performance of examinations, including procedures, summary documents, condensed document format and product instructions for use, are subject to document control. In addition to document control identifiers, documentation includes, when applicable to the examination procedure, the following:

1. purpose of the examination;
2. principle and method of the procedure used for examinations;
3. performance characteristics (see 5.5.1.2 and 5.5.1.3);
4. type of sample (e.g. plasma, serum, urine);
5. patient preparation;
6. type of container and additives;
7. required equipment and reagents;
8. environmental and safety controls;
9. calibration procedures (metrological traceability);
10. procedural steps;
11. quality control procedures;
12. interferences (e.g. lipaemia, haemolysis, bilirubinemia, drugs) and cross reactions;
13. principle of procedure for calculating results including, where relevant, the measurement uncertainty of measured quantity values;
14. biological reference intervals or clinical decision values;
15. reportable interval of examination results;
16. instructions for determining quantitative results when a result is not within the measurement interval;
17. alert/critical values, where appropriate;
18. laboratory clinical interpretation;
19. potential sources of variation;
20. references.

If the laboratory intends to change an existing examination procedure such that results or their interpretations could be significantly different, the implications are explained to users of the laboratory services after validating the procedure. NOTE 3: This requirement can be accomplished in different ways, depending on local circumstances. Some methods include directed mailings, laboratory newsletters or part of the examination report itself.

Procedure for ensuring quality of examination results confirms to following.

The laboratory ensures the quality of examinations by performing them under defined conditions. Appropriate pre and post-examination processes are implemented (see 4.14.7 Quality indicators , 5.4 Pre-examination processes, 5.7 Post-examination processes, 5.8 Reporting of results). The laboratory do not fabricate any results.

The laboratory designs quality control procedures that verify the attainment of the intended quality of results. NOTE: quality control, as referred to in this subclause, is also named “internal quality control.”

The laboratory uses quality control materials that react to the examining system in a manner as close as possible to patient samples. Quality control materials are 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.
NOTE 1: The laboratory chooses concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made.
NOTE 2: Use of independent third party control materials are considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.

The procedure ensures that the release of patient results do not occur 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 are rejected and relevant patient samples re-examined after the error condition has been corrected and within-specification performance is verified. The laboratory also also evaluates the results from patient samples that were examined after the last successful quality control event. Quality control data are 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 are taken and recorded.NOTE: Statistical and non-statistical techniques for process control are used wherever possible to continuously monitor examination system performance.

The laboratory participates in an interlaboratory comparison programme(s) (such as an external quality assessment programme or proficiency testing programme) appropriate to the examination and interpretations of examination results. The laboratory monitors the results of the interlaboratory comparison programme(s) and participate in the implementation of corrective actions when predetermined performance criteria are not fulfilled. NOTE: The laboratory participates in interlaboratory comparison programmes that substantially fulfil the relevant requirements of ISO/IEC 17043. The procedure ensures that interlaboratory comparison participation includes defined responsibilities and instructions for participation, and any performance criteria that differ from the criteria used in the interlaboratory comparison programme.
Interlaboratory comparison programme(s) chosen by the laboratory , as far as possible, provides clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre-examination procedures, and post-examination procedures, where possible.

Whenever an interlaboratory comparison is not available, the laboratory develops other approaches and provides objective evidence for determining the acceptability of examination results. Whenever possible, this mechanism utilizes appropriate materials.
NOTE: Examples of such materials may include:

1. certified reference materials;
2. samples previously examined;
3. material from cell or tissue repositories;
4. exchange of samples with other laboratories;
5. control materials that are tested daily in interlaboratory comparison programmes.

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

The performance in interlaboratory comparisons are reviewed and discussed with relevant staff. When predetermined performance criteria are not fulfilled (i.e. nonconformities are present), staff participates in the implementation and recording of corrective action. The effectiveness of corrective action is monitored. The returned results are evaluated for trends that indicate potential nonconformities and preventive action are taken.

The procedure defines means of comparing examination procedures, equipment and methods used and establishing the comparability of results for patient samples throughout the clinically appropriate intervals. This is applicable to the same or different procedures, equipment, different sites, or all of these.NOTE: In the particular case of measurement results that are metrologically traceable to the same reference, the results are described as having metrological comparability providing that calibrators are commutable. The laboratory notifies 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. The laboratory documents, records and, as appropriate, expeditiously acts upon results from the comparisons performed. Problems or deficiencies identified are acted upon and records of actions retained.

Procedure for review of results ensures that authorized personnel review the results of examinations before release and evaluate them against internal quality control and, as appropriate, available clinical information and previous examination results. When the procedure for reviewing results involves automatic selection and reporting, review criteria are established, approved and documented (see 5.9 Release of results, General).

Procedure for storage, retention and disposal of clinical samples ensures identification, collection, retention, indexing, access, storage, maintenance and safe disposal of clinical samples. The laboratory defines the length of time clinical samples are to be retained. Retention time is defined by the nature of the sample, the examination and any applicable requirements.NOTE: Legal liability concerns regarding certain types of procedures (e.g. histology examinations, genetic examinations, paediatric examinations) may require the retention of certain samples for much longer periods than for other samples.
Safe disposal of samples is carried out in accordance with local regulations or recommendations for waste management.

Procedure for reporting of results ensures following.

The results of each examination are reported accurately, clearly, unambiguously and in accordance with any specific instructions in the examination procedures. The laboratory defines the format and medium of the report (i.e. electronic or paper) and the manner in which it is to be communicated from the laboratory. The procedure ensures the correctness of transcription of laboratory results. Reports includes the information necessary for the interpretation of the examination results. The laboratory have a process for notifying the requester when an examination is delayed that could compromise patient care.

The laboratory ensure that the following report attributes effectively communicate laboratory results and meet the users’ needs:

1. comments on sample quality that might compromise examination results;
2. comments regarding sample suitability with respect to acceptance/rejection criteria;
3. critical results, where applicable;
4. interpretive comments on results, where applicable, which may include the verification of the interpretation of automatically selected and reported results (see 5.9.1 Release of results, general) in the final report.

The report includes, but not be limited to, the following:

1. a clear, unambiguous identification of the examination including, where appropriate, the examination procedure;
2. the identification of the laboratory that issued the report;
3. identification of all examinations that have been performed by a referral laboratory;
4. patient identification and patient location on each page;
5. name or other unique identifier of the requester and the requester’s contact details;
6. date of primary sample collection (and time, when available and relevant to patient care);
7. type of primary sample;
8. measurement procedure, where appropriate;
9. examination results reported in SI units, units traceable to SI units, or other applicable units;
10. biological reference intervals, clinical decision values, or diagrams/nomograms supporting clinical decision values, where applicable;NOTE: Under some circumstances, it might be appropriate to distribute lists or tables of biological reference intervals to all users of laboratory services at sites where reports are received.
11. interpretation of results, where appropriate;NOTE: Complete interpretation of results requires the context of clinical information that may not be available to the laboratory.
12. other comments such as cautionary or explanatory notes (e.g. quality or adequacy of the primary sample which may have compromised the result, results/interpretations from referral laboratories, use of developmental procedure);
13. identification of examinations undertaken as part of a research or development programme and for which no specific claims on measurement performance are available;
14. 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);
15. date of the report, and time of release (if not contained in the report, readily available when needed);
16. page number to total number of pages (e.g. “Page 1 of 5”, “Page 2 of 5”, etc.).

Procedure for release of results ensures that

1. Laboratory personnel who may release results are defined
2. Person who may receive results are defined.
3. When the quality of the primary sample received is unsuitable for examination, or could have compromised the result, this is indicated in the report.
4. When examination results fall within established “alert” or “critical” intervals:
   1. a physician (or other authorized health professional) is notified immediately [this includes results received on samples sent to referral laboratories for examination;
5. records are maintained of actions taken that document date, time, responsible laboratory staff member, person notified and examination results conveyed, and any difficulties encountered in notifications.
6. Results are legible, without mistakes in transcription, and reported to persons authorized to receive and use the information.
7. When results are transmitted as an interim report, the final report is always forwarded to the requester.
8. There are processes for ensuring that results distributed by telephone or electronic means reach only authorized recipients. Results provided orally are followed by a written report. There is a record of all oral results provided.
   

NOTE 1: For the results of some examinations (e.g. certain genetic or infectious disease examinations) special counselling may be needed. The laboratory should endeavour to see that results with serious implications are not communicated directly to the patient without the opportunity for adequate counselling.
NOTE 2: Results of laboratory examinations that have been separated from all patient identification may be used for such purposes as epidemiology, demography or other statistical analyses.

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

1. the criteria for automated selection and reporting are defined, approved, readily available and understood by the staff;NOTE: Items for consideration when implementing automated selection and reporting include changes from previous patient values that require review and values that require intervention by laboratory personnel, such as absurd, unlikely or critical values.
2. the criteria are validated for proper functioning before use and verified after changes to the system that might affect their functioning;
3. there is a process for indicating the presence of sample interferences (e.g. haemolysis, icterus, lipaemia) that may alter the results of the examination;
4. there is a process for incorporating analytical warning messages from the instruments into the automated selection and reporting criteria, when appropriate;
5. results selected for automated reporting are identifiable at the time of review before release and include date and time of selection;
6. there is a process for rapid suspension of automated selection and reporting.

When an original report is revised there are written instructions regarding the revision so that:

1. the revised report is clearly identified as a revision and includes reference to the date and patient’s identity in the original report;
2. the user is made aware of the revision;
3. the revised record shows the time and date of the change and the name of the person responsible for the change;
4. the original report entries remain in the record when revisions are made. Results that have been made available for clinical decision making and revised are retained in subsequent cumulative reports and clearly identified as having been revised. When the reporting system cannot capture amendments, changes or alterations, a record of such is kept.

Procedure for laboratory information management ensures following.

The laboratory have access to the data and information needed to provide a service which meets the needs and requirements of the user. The procedure ensures that the confidentiality of patient information is maintained at all times.NOTE In this International Standard, “information systems” includes the management of data and information contained in both computer and non-computerized systems. Some of the requirements may be more applicable to computer systems than to non-computerized systems. Computerized systems can include those integral to the functioning of laboratory equipment and stand alone systems using generic software, such as word processing, spreadsheet and database applications that generate, collate, report and archive patient information and reports.

The laboratory ensures that the authorities and responsibilities for the management of the information system are defined, including the maintenance and modification to the information system(s) that may affect patient care. The laboratory defines the authorities and responsibilities of all personnel who use the system, in particular those who:

1. access patient data and information;
2. enter patient data and examination results;
3. change patient data or examination results;
4. authorize the release of examination results and reports.

The system(s) used for the collection, processing, recording, reporting, storage or retrieval of examination data and information are:

1. validated by the supplier and verified for functioning by the laboratory before introduction, with any changes to the system authorized, documented and verified before implementation;NOTE: Validation and verification include, where applicable, the proper functioning of interfaces between the laboratory information system and other systems such as with laboratory instrumentation, hospital patient administration systems and systems in primary care.
2. documented, and the documentation, including that for day to day functioning of the system, readily available to authorized users;
3. protected from unauthorized access;
4. safeguarded against tampering or loss;
5. operated in an environment that complies with supplier specifications or, in the case of non-computerized systems, provides conditions which safeguard the accuracy of manual recording and transcription;
6. 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;
7. in compliance with national or international requirements regarding data protection.
   

The laboratory verifies that the results of examinations, associated information and comments are accurately reproduced, electronically and in hard copy where relevant, by the information systems external to the laboratory intended to directly receive the information (e.g. computer systems, fax machines, e-mail, website, personal web devices). When a new examination or automated comments are implemented, the laboratory verifies that the changes are accurately reproduced by the information systems external to the laboratory intended to directly receive information from the laboratory. The laboratory have contingency plans to maintain services in the event of failure or downtime in information systems that affects the laboratory’s ability to provide service. When the information system(s) are managed and maintained off-site or subcontracted to an alternative provider, laboratory management is responsible for ensuring that the provider or operator of the system complies with all applicable requirements of this International Standard.