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RS 818.101.32 Ordinance of 29 April 2015 on microbiology laboratories

Original Language Title: RS 818.101.32 Ordonnance du 29 avril 2015 sur les laboratoires de microbiologie

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818.101.32

Microbiology Laboratory Ordinance

April 29, 2015 (State 1 Er January 2016)

The Swiss Federal Council,

See art. 16, para. 2, of the Act of 28 September 2012 on Epidemics (LEp) 1 ,

Stops:

Section 1 General provisions

Art. 1 Purpose and scope

1 This order sets out the conditions and procedure for granting the authorisation:

A.
Microbiology laboratories which carry out diagnostic or epidemiological analyses in the field of transmissible diseases;
B.
Microbiology laboratories that analyze blood, blood products or transplants in order to exclude the presence of communicable diseases for the purpose of transfusion, transplantation or preparation;
C.
Laboratories conducting tests to identify a pathogen in samples taken from the environment as a result of an event B; are exempt from the authorization regime laboratories that analyze only Samples of foodstuffs, feedingstuffs or drinking water, other samples in the field of consumer protection and samples taken from the environment in order to detect outbreaks of Foodborne illness.

2 Laboratories that perform only basic care testing under s. 62 of the Medical Insurance Order of June 27, 1995 1 Enter the scope of this order only if they carry out the analyses referred to in para. 1, let. B.

1 RS 832.102

Art. 2 Competent Federal Authority

The granting of authorisation is within the competence of the Swiss Institute for Therapeutic Products.

Art. 3 Definitions

The term is:

A.
Diagnostic analysis: laboratory analysis to detect a communicable disease in a particular patient;
B.
Epidemiological analysis: laboratory analysis for early detection and surveillance of a communicable disease in the population, as well as the prevention and control of this disease;
C.
Analyses to exclude a communicable disease: laboratory analyses to exclude, during screening, the presence of a specific pathogen of a communicable disease in blood, blood products or transplants;
D.
Analysis of environmental samples: Laboratory analysis to identify a human pathogen in environmental samples as a result of a B event;
E.
Event B: Repeated natural occurrence or voluntary, involuntary or presumed release of a pathogen that is likely to cause significant harm.

Section 2 Conditions of authorisation

Art. 4 Laboratory Directorate

1 Any laboratory must be under the direction of a technical officer (head of laboratory).

2 The laboratory leader conducts direct technical monitoring of the laboratory.

3 He is responsible for interpreting the results and advising the prescriber.

Art. 5 Qualifications of laboratory head of a laboratory for diagnostic or epidemiological analysis

1 The head of a laboratory for diagnostic or epidemiological analysis must be able to justify a title conferred by the medical laboratory association of Switzerland (FAMH) of specialist FAMH in laboratory medicine or equivalent qualifications.

2 The laboratory chief can only carry out analyses which the Federal Department of the Interior (DFI) lays down on the basis of art. 52, para. 1, paragraph a, c. 1, Federal Act of 18 March 1994 on Medicare (LAMal) 1 , provided that the required specialization corresponds to its title FAMH.

3 For analyses that are not settled on the basis of s. 52, para. 1, paragraph a, c. 1 LAMal, the Swiss Institute for Therapeutic Products may define the qualifications of the laboratory head and lay down additional requirements.

1 RS 832.10

Art. 6 Qualifications of laboratory head of laboratory conducting analyses to exclude communicable diseases

The head of a laboratory conducting analyses to exclude communicable diseases must be able to justify one of the following:

A.
A FAMH FAMILY specialist in appropriate laboratory medicine for each of the analyses;
B.
A specialist title in haematology according to the Medical Professions Act of 23 June 2006 (LPMed) 1 As well as evidence that it has the professional competence necessary for the conduct and interpretation of the analyses carried out; or
C.
Equivalent qualifications.

1 RS 811.11

Art. 7 Qualifications of laboratory head of a laboratory conducting environmental sampling analyses

The head of a laboratory carrying out analyses of environmental samples must be able to justify one of the following qualifications:

A.
A FAMH FAMILY specialist in appropriate laboratory medicine for each of the analyses;
B.
A diploma in chemistry, biochemistry, biology or microbiology issued by a high school accredited within the meaning of the Law of 30 September 2011 on the encouragement and coordination of high schools (LEHE) 1 Or by a foreign university high school recognized or accredited by the State, as well as proof that it has the professional competence necessary for the conduct and interpretation of the analyses carried out; for graduates in chemistry, Biochemistry or biology, two years of professional experience in microbiology analyses are also required;
C.
A university degree in human medicine, dentistry, veterinary medicine or pharmacy, consistent with the LPMed 2 , and two years of professional experience in the analysis of microbiology, as well as evidence that he has the professional skills necessary to carry out and interpret the analyses carried out; or
D.
Equivalent qualifications.

1 RS 414.20
2 RS 811.11

Art. 8 Qualifications and professional experience of laboratory personnel

1 At least half of the staff of a laboratory performing analyses must be able to justify one of the following degrees:

A.
One of the following diplomas in accordance with the Federal Act of 13 December 2002 on vocational training (LFPr) 1 :
1.
A federal degree in biomedical analysis,
2.
A federal laboratory laboratory capacity certificate and at least two years of professional experience in microbiology analysis,
3.
A foreign degree recognized as equivalent under s. 68 LFPr;
B.
A degree in chemistry, biochemistry, microbiology or biology from a high school accredited high school according to the LEHE 2 Or by a high school recognized or accredited by the Etat;
C.
A degree in chemistry, biochemistry, microbiology or biology delivered by a specialized high school accredited by the LEHE or by an accredited high school accredited or accredited by the Etat; or
D.
A university degree in human medicine, dentistry, veterinary medicine or pharmacy, consistent with the LPMed 3 .

2 At least half of the staff in a laboratory performing analyses must have at least one year of professional experience in the field of microbiology analysis.

1 RS 412.10
2 RS 414.20
3 RS 811.11

Art. Premises and Facilities

The laboratory must have suitable premises and be equipped with the necessary equipment and facilities.

Art. 10 Quality Management System

The laboratory must have a quality management system.

Section 3 Authorization and Control

Art. 11 Request for authorization

1 The application for authorisation to operate a laboratory must be submitted to the Swiss Institute for Therapeutic Products.

2 The application must include the following:

A.
Indications of the legal person and the status of commercial law, including the name, location, address, name and location of the laboratory;
B.
Indications concerning the organisation of the operation of the laboratory;
C.
Indications of the qualifications of the laboratory head within the meaning of s. 5;
D.
Indications of the occupancy rate of the laboratory leader and possible commitments in other laboratories;
E.
Indications of the qualifications of staff performing analyses within the meaning of Art. 8;
F.
Plans for the laboratory and major facilities;
G.
A list of planned analyses and procedures for this purpose;
H.
Indications of the quality management system.

3 The Swiss Institute of Therapeutic Products reviews the application. It may conduct an inspection prior to the granting of the authorization.

4 It may use experts to examine applications and delegate inspection of laboratories to cantons or third parties.

Art. 12 Granting of authorisation and duration of validity

1 If the laboratory meets the conditions set out in s. 4 to 10, the Swiss Institute for Therapeutic Products grants the authorisation.

2 Based on the qualifications of the laboratory head (art. 5 to 7), the authorisation is granted only for certain fields of analysis and analytical procedures.

3 The authorisation shall be valid for up to five years.

4 The renewal of the authorisation must be requested no later than six months before its expiry. The application shall contain or confirm the indications referred to in Art. 11, para. 2.

Art. 13 Control

1 The Swiss Institute of Therapeutic Products shall periodically check whether the laboratory complies with the provisions of this order.

2 It may at any time carry out or order announced or unannounced inspections of the laboratory. It may delegate the inspection to the cantons or to third parties.

3 It may call on external experts to carry out inspections.

4 It shall notify the competent cantonal authority and, in the case of accredited laboratories, the Swiss Accreditation Service (SAS), of inspections and may invite representatives of these authorities to participate in the inspections.

Art. 14 Accredited Laboratories

1 Where a laboratory with an authorization within the meaning of this order is accredited in accordance with the order of 17 June 1996 on accreditation and designation 1 , the Swiss Institute for Therapeutic Products decides whether the SAS controls replace the accredited field with the periodic inspections referred to in Art. 13.

2 If the SAS carries out checks, it checks whether the laboratory complies with the legal provisions and informs the Swiss Institute of Therapeutic Products. The Swiss Institute for Therapeutic Products and the competent cantonal authority can take part in the checks.

3 The SAS informs the Swiss Institute of Therapeutic Products of the renewal, withdrawal or suspension of accreditation, as well as any changes in the accredited field.

4 The laboratory shall make available to the Swiss Institute for Therapeutic Products, at the request of the latter, evidence relating to the accreditation procedure.

1 RS 946.512

Art. 15 Withdrawal, suspension or restriction of the authorisation

The Swiss Institute for Therapeutic Products may withdraw, suspend or restrict authorization where:

A.
The conditions attached to the authorisation are no longer fulfilled;
B.
Obligations under s. 16 to 20 and the requirements of s. 21 are not being met;
C.
The results of external quality control give rise to repeated challenges.

Section 4 Laboratory obligations

Art. 16 1 Good Practices

Laboratories conducting diagnostic or epidemiological analyses and analyses to exclude the presence of a communicable disease must conform to the good practices of the microbiology laboratories set out in Annex 1.

1 Erratum of 9 June 2015 ( RO 2015 1689 ).

Art. 17 Quality Management and External Quality Controls

1 Laboratories conducting diagnostic or epidemiological analyses and analyses to exclude the presence of a communicable disease must establish the quality management system referred to in s. 10 taking into account the standards set out in Annex 2, c. 1.

2 Laboratories conducting environmental sampling analyses shall establish the quality management system referred to in s. 10 taking into account the standard set out in Annex 2, c. 2. The Swiss Institute for Therapeutic Products may publish a guide to this effect.

3 Laboratories must regularly submit to external quality control.

Art. 18 Respect for diagnostic concepts

1 Laboratories acting as reference centres or confirmatory laboratories under s. 17 LEp are required to respect the diagnostic concepts defined by the Federal Office of Public Health (FOPH).

2 Laboratories establishing primary diagnoses are required to comply with the diagnostic concepts defined by the FOPH.

3 The FOPH may declare that the concepts of diagnosis of international institutions are binding.

Art. 19 Retention of Records

1 Documents prepared for internal quality management, laboratory journals and analytical reports shall be kept for at least five years and made available to the Swiss Institute for Therapeutic Products on request.

2 Documents prepared for external quality control shall be kept for at least five years and made available to the Swiss Institute for Therapeutic Products on request.

3 Laboratory journals and analytical reports for analyses to exclude the presence of a communicable disease must be retained for 20 years.

4 The laboratory must take the necessary technical and organizational measures to protect the analytical reports and all other patient data from unauthorized access.

Art. Announcement of Changes and Adaptation of the Authorization

1 The laboratory shall file with the Swiss Institute of Therapeutic Products for any modification of the indications referred to in Art. 11, para. 2, an application accompanied by the necessary documents.

2 The Swiss Institute of Therapeutic Products shall decide within 30 days on applications within the meaning of para. 1 and, where appropriate, adapts the authorization.

Section 5 Conduct of analyses abroad

Art.

Laboratories holding an authorization within the meaning of this order shall not entrust diagnostic or epidemiological analyses, analyses to exclude the presence of a communicable disease or analyses of samples Obtained from the environment at a foreign laboratory only if carried out in accordance with the state of science and technology, comply with the quality requirements of this order, and that data protection is Warranty.

Section 6 Information

Art. Publications

1 The Swiss Institute of Therapeutic Products publishes annually a list of laboratories licensed under this order.

2 This list contains the following information:

A.
The name and address of the laboratory
B.
The name of the laboratory leader;
C.
Areas of analysis.
Art. Information from the authorities

1 The Swiss Institute of Therapeutic Products shall inform the OFSP and the competent cantonal authority of the granting, renewal, withdrawal and suspension of authorisations. It makes available to the FOPH a file containing the addresses of the authorized laboratories.

2 The FOPH shall inform the Swiss Institute of Therapeutic Products of its activities, provided that they are relevant for the granting of authorisations and for the control of laboratories.

Section 7 Fees

Art. 24

The emoluments are calculated according to the order of 2 December 2011 on the emoluments of therapeutic products 1 .

1 RS 812.214.5

Section 8 Amendment of annexes

Art. 25

1 The DFI may amend Annexes 1 and 2 in order to adapt them to international developments or technical developments.

2 It consults with the Federal Department of Economics, Training and Research when an amendment is likely to constitute a technical barrier to trade.

Section 9 Final provisions

Art. 26 Repeal of another act

The Ordinance of 26 June 1996 on microbiology and serology laboratories 1 Is repealed.

1 [RO 1996 2324, 2001 3294 hp. II 11, 2003 4835, 2004 4037 hp. II al. 1]

Art. 27 Change in Other Acts

The following acts are amended as follows:

... 1

1 The mod. Can be viewed at RO 2015 1497 .

Art. 28 Transitional provisions

1 Authorisations granted under the old right shall remain valid until the expiry of their validity.

2 Recognitions referred to in s. 5, para. 1, of the Act of 18 December 1970 on Epidemics 1 Remain valid until the expiry of their validity or, at the latest, five years after the coming into force of this order.

3 The Swiss Institute of Therapeutic Products shall convert the authorisations and recognitions issued under the old right into authorisations in accordance with this order as soon as an amendment is announced.

4 Laboratories that have not so far been subject to the authorisation scheme or who do not have valid recognition and who now need an authorisation are required to file an application within one year of The coming into force of this Order. They may continue to carry out analyses until the Swiss Institute for Therapeutic Products has decided on their request.

5 If the qualifications of the laboratory head do not comply with the requirements of this order, the Swiss Institute for Therapeutic Products may grant a maximum period of three years for them to be.

1 RO 1974 1071

Art. Entry into force

This order shall enter into force on 1 Er January 2016.

Annex 1

(art. 16)

Good microbiological laboratory practices

1 Introduction

1.1
Good microbiological laboratory practices allow laboratories to work according to comparable ground rules and measurable standards.
1.2
Good practice in microbiology laboratories is based on the European standards SN EN ISO/IEC 17025, 2005, "General requirements for the competence of calibration and testing laboratories" and SN EN ISO/IEC 15189, 2012, " Laboratories Medical biology analysis-Specific quality and competency requirements " 1 .

2 Direction

2.1 Direction of more than one laboratory

2.1.1
A laboratory leader who directs more than one laboratory is required to have a principal place of duty. All expenses shall not exceed the equivalent of a full time.
2.1.2
The laboratory leader must be able to demonstrate the responsibility he assumes in each laboratory; he maintains a record of his time and activity in each laboratory.
2.1.3
The back-up shall be settled in each laboratory. The laboratory chief or his/her replacement must be achievable during working hours. In the absence of the first, the presence of the replacement shall be recorded in a register.

2.2. Responsibilities of the Laboratory Leader

2.2.1
The Laboratory Manager is responsible for the personnel, compliance and validity of the analytical procedures, as well as the compliance of equipment, devices and reagents. It responds to the quality and interpretation of the results of the analyses (laboratory results).
2.2.2
It is permissible to delegate the functions of the laboratory head only to persons with the required professional qualifications. The head of laboratory shall exercise supervision over delegated functions. It cannot delegate this task.
2.2.3
The laboratory head shall be bound by professional secrecy for all the information he or she is aware of in the course of his or her profession.

2.3 Continuing Education

The laboratory leader must keep abreast of the current state of science and technology through continuous training. It is supposed to be able to produce proof of such training at all times.

3 Personnel

3.1 Qualifications

The Laboratory Manager is expected to be able to provide evidence at all times that he has sufficient staff and that he has the qualifications and experience required to perform his/her work.

3.2 Responsibilities

3.2.1
Technical personnel are responsible for:
A.
Carrying out analyses according to laboratory instructions and procedures;
B.
Maintenance of equipment, equipment and reagents;
C.
Application of the instructions in the quality assurance manual (c. 4).
3.2.2
Personnel shall be subject to professional secrecy for all the information they are aware of in the performance of their duties.

3.3 Information

3.3.1
Upon entry into office, new employees must be provided with complete information on the quality assurance system.
3.3.2
They must also be given precise specifications and in which they have their responsibilities.
3.3.3
The procedures they will use with or without supervision are set after assessment of their competencies.
3.3.4
Information within the meaning of this figure for new employees must be given to them in an appropriate form.

3.4 Continuing Education

3.4.1
The laboratory manager must regularly check the skills of the staff. It proposes the continuous training necessary for the performance of its tasks.
3.4.2
The Laboratory Leader is responsible for the ongoing training of staff and their written certification.

4 Equipment and Materials

4.1 Premises

4.1.1
The number, size and infrastructure of the premises must correspond to the intended use of the premises. Premises such as offices, health facilities, living rooms, etc., must be separated from the laboratories themselves.
4.1.2
The provision of premises and their equipment must ensure that the work process is carried out in accordance with the state of science and technology.
4.1.3
Premises with specific equipment, behaviour and logistics requirements must be reported and, where appropriate, restricted to specially trained laboratory personnel; these requirements must be met. Be settled in writing.
4.1.4
The reception, the waiting room and the premises where the samples are taken must be hygienic, comfortable, adapted to their intended purpose and designed to preserve an adequate and intimate sphere.
4.1.5
Health facilities for patients should be separated from those of staff.

4.2 Security

4.2.1
Access to premises is restricted to authorized persons. Inputs and exits of unauthorized persons are monitored; the access pattern and time of entry and exit are documented.
4.2.2
Unauthorized persons are educated at the time of entering risks and the rules of conduct to be observed, as well as confidentiality rules.
4.2.3
Materials that pose a risk to the quality of the analyses (the enriched pathogens, the amplified nucleic acids of pathogens, radioactive substances, etc.) must be stored or temporarily stored in premises Separate reserve equipment (culture media, reagents, etc.). Disposal of such materials, reagents or samples shall be resolved in writing.
4.2.4
There shall be sufficient facilities with sufficient capacity for the disposal of such materials, reagents or samples within the meaning of the c. 4.2.3, in particular for the disposal of infectious wastes or materials containing highly enriched nucleic acids of pathogens.
4.2.5
The disposal channels, as well as the cleaning of laboratory facilities and workstations, must be resolved and correspond to the defined processes. In particular, it is necessary to take into account the risk that analytical systems and analysis results may be affected by inappropriate behaviour and such materials.
4.2.6
All employees must be informed and educated about this.

4.3 Methods, Instruments, Reagents and Equipment

4.3.1
The choice of analytical systems and procedures, methods, instruments, reagents and consumable material is determined by the clinical requirements, in particular as regards analytical and diagnostic sensitivity, specificity, Accuracy, repeatability, reproducibility, including known interferences and detection thresholds, and duration of execution.
4.3.2
Compliance with the benefit parameters must be guaranteed at all times. Their suitability must be monitored and they must be in accordance with the state of science and technology.
4.3.3
The instruments must conform to the state of the art. Each instrument must have a standard operating procedure (SOP).

5 Quality Assurance Manual

5.0 Principle

5.0.1
The laboratory has a quality assurance manual and keeps it up to date.
5.0.2
This manual contains a description of all laboratory activities and should be made available to all staff.
5.0.3
Instructions and procedures are recorded and dated.
5.0.4
They are validated by the editor and by the laboratory chief when they are introduced and modified, and communicated to the staff concerned.
5.0.5
A person must be appointed to be responsible for the quality assurance manual. It assists the head of the laboratory in any question relating to quality assurance.
5.0.6
The content of the quality assurance manual is based on the ch. 5.1. To 5.19.

5.1 Quality policy

5.1.1
The laboratory quality policy describes the purpose and scope of the benefits provided.
5.1.2
The quality policy must be regularly monitored.

5.2 Indications on the Laboratory

The indications concern the business reason, the addresses of the company and laboratory headquarters, the benefit catalogue, the structure and the organisation chart, the names of the employees and their responsibilities.

5.3 Records Management

5.3.1
Preparation of the patient, obtaining of the patient's material, collection of samples to be analysed (collection), reception, identification, storage, transport and preparation of samples, as well as the preparation of the report Of analysis, shall be carried out in accordance with written procedures.
5.3.2
Minutes must be kept, and duly signed, for all work performed in the laboratory.

5. Request for Analyses

5.4.1
The request for analysis must include at least the following indications:
A.
The patient's unequivocal identification;
B.
The name, address and telephone number of the prescriber;
C.
Description of the patient's equipment;
D.
The analyses requested;
E.
The date and time of obtaining the patient's equipment;
F.
Data necessary and useful for medical and microbiological interpretation;
G.
Other information required to complete the request.
5.4.2
If analyses are carried out by specialized laboratories, the agent laboratories and the analyses carried out and their results must be documented.

5.5 Equipment to be analyzed

5.5.1
Upon receipt of the application or material, the laboratory shall examine whether the application can be carried out. Before performing the analysis, it ensures compliance of the material to be analyzed. If the analysis is not done immediately, it will take all necessary measures to ensure the integrity of the material.
5.5.2
The primary sample and the secondary samples that come from are identified in such a way that it is possible, at all times (in the preanalytical, analytical or post-analytical phases), to find their origin, the date of collection and Any other important information.
5.5.3
The primary sample and the secondary samples are retained according to written requirements.
5.5.4
Instructions shall be provided for the collection, identification, documentation, storage and transport of samples, as well as for the treatment of samples residues.

5.6 Report

The results are communicated to the prescriber in writing, with specific patient data and an interpretation based on existing data.

5.7 Data Processing

5.7.1
Only authorized persons have access to data and data processing systems. Any program or system changes and failures must be documented.
5.7.2
Data carriers (electronic media, microfilm, etc.) for storage and archiving must be protected from destruction and damage. The laboratory must guarantee the possibility of making paper draws at any time.
5.7.3
Hardware (hardware) and software (software) must be secured in order to avoid data loss.
5.7.4
Systems are validated and monitored to ensure that the specifications and benefits of a given system can be achieved at all times.
5.7.5
When devices and analysis machines are integrated into the laboratory information system, data transfer and processing are validated and monitored.
5.7.6
Systems must be protected from any undesirable mutual or external influence.
5.7.7
Access to data and systems is permitted only to persons authorized and kept in professional secrecy.

5.8 Equipment

5.8.1
Only test kits, apparatus and reagents can be used in accordance with the Medical Devices Ordinance of 17 October 2001 (ODim) 2 This also includes products manufactured in the laboratory.
5.8.2
The quality of the reagents and consumable material must be guaranteed.
5.8.3
Reagents, culture media, quality control equipment, calibrators and consumable equipment must be labelled with the necessary indications, the date of receipt and the expiry date, and kept properly. A protocol of these indications must be maintained for each analytical system.
5.8.4
The following rules apply to the control of culture media, reagents, dyes and solutions, auxiliary devices and diagnostic serums, as well as to the control of antibiotic efficacy:
5.8.4.1
In the case of the use of finished products marketed, the choice must relate to those whose seller can guarantee by a certificate the quality and the irreproachable functioning. Additional quality control is optional and should be done at least in questionable analytical results.
5.8.4.2
For culture media, reagents, dyes, solutions and auxiliary equipment manufactured in the laboratory, each lot must be recorded separately. Possible sources of error, such as water quality, imprecise weighing, volume annotation error, overheating, incorrect pH, soiled receptacles, etc. should be ensured. The documentation includes the following particulars: name, date of manufacture, lot number, results of internal quality control, date of authorization for routine use and expiry date. A protocol is maintained for each system and analysis procedure, with an indication of this data.
5.8.4.3
Containers of dehydrated media bear the date of their first opening.
5.8.4.4
The shelf life of the culture media and the transport media should be specified.
5.8.4.5
The suitability of the transport media must be microbiologically controlled (survival of control strains). This control will also examine sterility, the properties of stimulation, selection, or inhibition of growth, as well as on the differential effect through corresponding control strains.
5.8.4.6
Control is carried out using appropriate test organisms prior to the first use following purchase or production in the laboratory.

5.9 Analytical systems and procedures

5.9.1
The laboratory uses analytical systems for the intended purpose of the manufacturer. It guarantees the support, prior to any treatment of patient samples, that the benefits indicated by the manufacturer may be reproduced in the laboratory.
5.9.2
If an analysis system is modified or the laboratory develops its own procedure, the benefits of the analytical system (analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, Reproducibility, including known interference and detection limit and processing time) are established and documented prior to any treatment of patient samples.
5.9.3
User training is documented.
5.9.4
The laboratory ensures, through regular monitoring, that the specified benefits are met at all times.
5.9.5
The correct use, handling in the rules of art, regular cleaning, maintenance and regular monitoring of benefits and safety shall ensure the proper functioning of the analytical systems, apparatus and means Auxiliary (accessories).
5.9.6
The manufacturer's instructions must be followed when using systems that have been established for compliance. The requirements set by the laboratory apply to systems that it has modified or developed.
5.9.7
Maintenance work undertaken is documented in a protocol and documented. Protocols shall contain the description of the controls carried out, the measured values, the date, the name of the verifier, any measures taken to restore the proper functioning and the monitoring of the effectiveness of those measures.

Calibration and calibration control

5.10.1
Calibration and control shall be carried out according to the manufacturer's instructions or, in the case of clean procedures or procedures modified by the laboratory, according to the instructions of the laboratory.
5.10.2
The type, number, concentration, limits of tolerance and frequency of calibration shall be specified. As far as possible, the calibration is performed in relation to a reference material or method.
5.10.3
A calibration check shall also be carried out if a new batch of reagents is used, if important maintenance work has been carried out or if the quality control so requires, but at least every six months.
5.10.4
A protocol for calibration and control is maintained for each analytical system.
5.10.5
The volume constancy of the dilutors, distributors, pipetters and handles must be monitored regularly.

5.11 Operational problems

5.11.1
For each analytical system, there are instructions for the measures to be taken in the event of malfunction. The problems and corrective measures taken shall be documented in writing.
5.11.2
The criteria for corrective measures should be specified.

5.12 Technical Manual

5.12.1
Staff shall work in accordance with established written methods, which shall be compiled in a technical manual available at all times.
5.12.2
The technical manual shall contain for each analytical technique, if applicable, the following data:
A.
The principle of analysis;
B.
The procedure relating to the obtaining of the patient's equipment and the requirements relating thereto, the processing of the material to be analysed and the sample, the nature and properties of the sample, the storage conditions and the measures to be taken when the Requirements are not met;
C.
Reagents (purity, preparation, preservation, etc.);
D.
Calibrators, calibration, use and handling;
E.
Control equipment and procedures;
F.
Detailed instructions for work, critical manipulations, procedures and framework conditions (y. C. Accommodation requirements, p. Ex. For PCR and cell cultures);
G.
Calculation and interpretation;
H.
The parameters of analytical and diagnostic benefits (specificity, sensitivity, useful domain, grey area, measures to be taken if values are too high or too low);
I.
The limits of biological plausibility, usual values, areas of clinical alert, and measures to be taken in case of exceedance of limit values;
J.
Analytical and biological interference;
K.
The seizure and transmission of the findings and results of the analysis;
L.
The drafting of the report and its contents (outcome of the measures, interpretation, limit values, remarks, subcontractors, etc.);
M.
The step-by-step plan for measures to be taken in the event of malfunctioning of the analytical system;
N.
Own benefits and third-party benefits.
5.12.3
Package inserts, handouts and user manuals for device and reagent manufacturers can be incorporated into the technical manual and replace it in part.
5.12.4
For analyses entrusted to other laboratories, the technical manual also contains instructions for preparation, labelling, packaging and transport.

5.13 Safety and health requirements

5.13.1
Each laboratory must establish safety and hygiene requirements, in order to minimise the risks for the proper functioning of the analytical systems and for the results.
5.13.2
All employees must apply the prescribed measures; these measures form part of their continuing education and training. In particular:
5.13.2.1
Consideration must be given, in the course of the activities carried out by the collaborators, that persons carrying bacteria or, where appropriate, infected, constitute a risk for the identification of the pathogen concerned;
5.13.2.2
Laboratory areas that pose a specific risk of contamination need to be reported;
5.13.2.3
Workstations must be cleaned. Contaminated workstations must be disinfected and decontaminated effectively, according to established standards and procedures;
5.13.2.4
Where necessary, the work must be performed under safety hoods. Containers must be closed.
5.13.2.5
Manipulation must be defined to minimize the production and spread of aerosols, as well as contamination by soiling. Aerosols and contamination by soiling must be minimized, by appropriate measures, and monitored to avoid any loss of quality of the results of the analyses. Measures must be defined to protect against aerosols produced.
5.13.2.6
Centrifuges must be closed during centrifugation;
5.13.2.7
The head of the laboratory must be informed in the event of an accident with a potential risk of contamination, such as broken glass during centrifugation, dispersion of biological material, etc.
5.13.2.8
The wearing and changing of protective clothing, gloves, protective eyewear, etc., is adjusted to meet the requirements of the activity in question.
5.13.2.9
It is forbidden to eat and drink in laboratories, as well as to deposit food and drinks, personal medicines, etc., in the laboratory area.

5.14 Analytical quality control

5.14.1
Tolerance limits are set according to the clinical requirements and technical possibilities of each analytical system.
5.14.2
The laboratory ensures that the limits of tolerance are not crossed.
5.14.3
At each set of patient sample controls are added internal control samples which, at all analytical steps, are treated as patient samples. Periodically, quality control samples (e.g. sensitivity checks) are added to ensure that the values obtained by all system components (reagents, apparatus, internal quality controls and Calibrators) are not less than or greater than the tolerance limits.
5.14.4
The results of the control samples are verified according to the limits set before the results of the patient samples are reported. In addition, a trend analysis of the accuracy and accuracy of testing systems is conducted on a monthly basis.
5.14.5
An analytical quality control protocol is maintained for each analytical system.
5.14.6
In the context of a particularly sensitive molecular diagnosis, periodic checks are carried out to exclude transfer, cross-contamination or contamination with target nucleic acids in the environment.
5.14.7
The laboratory has a collection of strains (references) for virological, bacteriological, mycological, parasitological and immunoserological quality controls.

5.15 Correcting measures

5.15.1
To ensure continuity of benefits, detailed instructions and a list of measures to be taken must be established when:
A.
The analytical system deviates from its specifications;
B.
The results of quality control or calibration verification require the cancellation of the results of a series of analyses;
C.
The laboratory communicated a false result.
5.15.2
If the laboratory has communicated a false result, it shall notify the prescriber and provide it with a corrected report. The original result should not be destroyed.
5.15.3
A protocol of the correction measures shall be maintained for each analytical system.
5.15.4
Criteria for corrective action and proof of effectiveness must be established.

5.16 Collaboration with Prescribers

5.16.1
The laboratory provides the Prescribers with the following information:
A.
A list of benefits, the indication of subcontracting analyses and the name of the sub-contractor;
B.
Instructions for preparing patients, obtaining patient material, identifying, storing, packaging and transporting samples;
C.
Application forms or other appropriate means to request an analysis.
5.16.2
Analysis reports shall be submitted within the agreed time frame, with the technical result or laboratory diagnosis.
5.16.3
The head of the laboratory clarifies, in a telephone conversation with the attending physician, the critical results, which are difficult to interpret, implausible or unusual.
5.16.4
Each written complaint is handled in a pre-defined manner.

5.17 Collaboration with Suppliers

The laboratory receives from its suppliers the description and the manner of use of their products and services. It shall inform them of any irregularities or problems arising during the use.

5.18 Collaboration with other laboratories

5.18.1
When dealing with subcontracting mandates, the laboratory informs the prescriber of the analytical system used, communicates the results of the quality control and allows the prescriber requesting it to carry out an on-the-spot appraisal.
5.18.2
As a prescriber, the laboratory guarantees the quality assurance of the agent, if necessary by technical expertise on site. It indicates in its analysis report the name of the agent and the name of the analytical system used.

5.19 Professional secrecy for subcontractors

When performing subcontracting work such as the maintenance of the computer system or other maintenance work which provides access to confidential data, the laboratory shall indicate in writing to the representative that it is required to Professional secrecy.

6 External Quality Control

6.1
The laboratory is subject to external quality control for its field of activity.
6.2
The analyses of external quality control are carried out in the same way as the analyses of patient samples.

7 Quality Assurance

7.1
The head of the laboratory is responsible for the quality of the benefits.
7.2
The head of the laboratory ensures constant compliance with the instructions of the quality assurance manual and the systematic nature of the controls in this field. It supports staff in the performance of their tasks. It pays particular attention to the adequacy of the corrective measures, to the handling of complaints and complaints, and to the recording, dated and signed, of any event affecting the quality of the benefits.
7.3
Each correction measure is integrated as soon as possible in the quality assurance manual.

1 These standards can be consulted at the Swiss Institute for Therapeutic Products, Hallerstrasse 7, 300 Bern 9 or obtained from the Swiss Swiss Centre for Information on Technical Rules (switec), Bürglistrasse 29, 8400 Winterthur; www.snv.ch
2 RS 812.213

State 1 Er January 2016

Annex 2

(art. 17)

Quality Management Systems in Laboratories

1. When developing quality management systems, laboratories carrying out diagnostic or epidemiological analyses and analyses to exclude communicable diseases take into account ISO standards 1 Following:

A.
SN EN ISO/IEC 17025: 2005 (General requirements for the competence of calibration and testing laboratories);
B.
SN EN ISO/IEC 15189: 2012 (Laboratories for analysis of medical biology-Special requirements concerning quality and competence)

2. When developing quality management systems, laboratories performing environmental sampling analyses take into account the ISO standard. 2 Next:

SN EN ISO/IEC 17025: 2005 (General requirements for the competence of calibration and testing laboratories).

1 These standards can be consulted at the Swiss Institute for Therapeutic Products (Swissmedic), Hallerstrasse 7, 3000 Berne 9; they can also be ordered from the Swiss Association for Standardization (switec), Bürglistrasse 29, 8400 Winterthur; www.snv.ch.
2 This standard can be consulted at the Swiss Institute for Therapeutic Products (Swissmedic), Hallerstrasse 7, 3000 Bern 9; it can also be ordered from the Swiss Association for Standardization (switec), Bürglistrasse 29, 8400 Winterthur; www.snv.ch

State 1 Er January 2016