Standard
Track updates
AS ISO 22367:2021
[Current]Medical laboratories — Application of risk management to medical laboratories
Identically adopts ISO 22367:2020, which specifies a process for a medical laboratory to identify and manage the risks associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. KEYWORDS: Risk management; Medical laboratory; Clinical; Patients
Published: 16/04/2021
Pages: 83
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management
4.1 Risk management process
4.2 Management responsibilities
4.3 Qualification of personnel
4.4 Risk management plan
4.4.1 General
4.4.2 Scope of the plan
4.4.3 Contents of the plan
4.4.4 Revisions to the plan
4.4.5 Risk management documentation
5 Risk analysis
5.1 General
5.2 Risk analysis process and documentation
5.3 Intended medical laboratory use and reasonably foreseeable misuses
5.4 Identification of characteristics related to safety
5.5 Identification of hazards
5.6 Identification of potentially hazardous situations
5.7 Identification of foreseeable patient harms
5.8 Estimation of the risk(s) for each hazardous situation
6 Risk evaluation
6.1 Risk acceptability criteria
6.2 Risk evaluation process
7 Risk control
7.1 Risk control options
7.2 Risk control verification
7.3 Role of standards in risk control
7.4 Role of IVD medical devices in risk control
7.5 Risks arising from risk control measures
7.6 Residual risk evaluation
8 Benefit-risk analysis
9 Risk management review
9.1 Completeness of risk control
9.2 Evaluation of overall residual risk
9.3 Risk management report
10 Risk monitoring, analysis and control activities
10.1 Surveillance procedure
10.2 Internal sources of risk information
10.3 External sources of risk information
10.4 Immediate actions to reduce risk
Annex A
A.1 General guidance
A.2 Documents and records control
A.3 Supplier management
A.3.1 General
A.3.2 Purchasing
A.3.3 Acceptance activities
A.3.4 Servicing
A.4 Design and development activities
A.4.1 General
A.4.2 Design and development planning
A.4.3 Design and development input
A.4.4 Design and development outputs
A.4.5 Design and development review
A.4.6 Design and development verification
A.4.7 Design and development validation
A.4.8 Design and development transfer
A.5 Identification and control of nonconformities
A.6 Complaint evaluation and investigation
A.7 Corrective action
A.8 Preventive action
A.9 Continual improvement
A.10 Evaluation and audits
A.11 Accommodation and environmental controls
A.12 Control of laboratory equipment, reagents and consumables
A.13 Control of laboratory information systems
A.14 Quality control of examination processes
A.15 Change management
Annex B
B.1 General
B.2 Scope of the plan
B.3 Assignment of responsibilities and authorities
B.4 Requirements for review of risk management activities
B.5 Criteria for risk acceptability
B.6 Verification activities
B.7 Method or methods of obtaining relevant information for risk monitoring
Annex C
C.1 General
C.2 Methods of determining acceptable risk
C.3 Recommendations
C.4 Risk matrix
Annex D
D.1 General
D.2 Characteristics related to safety for examination procedures, including IVD medical devices
D.2.1 General
D.2.2 Performance characteristics of quantitative examination procedures
D.2.3 Performance characteristics of qualitative examination procedures
D.2.4 Reliability or dependability characteristics
D.2.5 Ancillary patient information
D.3 Generic questions pertaining to IVD medical devices and medical laboratory examinations
D.3.1 What is the intended use and how are the examination results used?
D.3.2 Is the IVD medical device or examination procedure intended for use at the point of care?
D.3.3 What materials or components are utilized to verify, validate or control the equipment used to perform the examination?
D.3.4 Are the reagents stored under special conditions to ensure stability?
D.3.5 Is the equipment or IVD medical device intended to be routinely cleaned and disinfected by the laboratory?
D.3.6 Are measurements correctly performed?
D.3.7 Do the examination results require interpretation by the laboratory or the healthcare provider?
D.3.8 Is the examination procedure intended for use in conjunction with other examinations or IVD medical devices?
D.3.9 Are the examination results intended for use by the healthcare provider in conjunction with other examination results?
D.3.10 Are there unwanted outputs of energy or substances generated by the measurement system or the examination procedure?
D.3.11 Is the instrumentation or IVD medical device susceptible to environmental influences?
D.3.12 Are there essential consumables or accessories associated with the examination procedure or IVD medical device?
D.3.13 Is maintenance or calibration necessary?
D.3.14 Does the examination procedure or IVD medical device contain or use software?
D.3.15 Do the components of the examination procedure or IVD medical device have a restricted shelf-life?
D.3.16 Are there any delayed or long-term use effects?
D.3.17 What determines the lifetime of the examination components or IVD medical device?
D.3.18 What is the intended use and how are the examination results used?
D.3.19 Is the medical device intended for single use or multiple use
D.3.20 Is safe disposal of the consumables or any waste materials necessary?
D.3.21 Is safe decommissioning of the equipment or IVD medical device necessary?
D.3.22 Does installation or use of the equipment or IVD medical device require special training or special skills?
D.3.23 How will information for safe use be provided?
D.3.24 Will new examination processes need to be established, introduced or modified?
D.3.25 Is successful use of the instrumentation or IVD medical device critically dependent on human factors, such as the user interface?
D.3.26 Can the user interface design contribute to use error?
D.3.27 Is the IVD medical device used in an environment where distractions can cause use error?
D.3.28 Does the IVD medical device have connecting parts or accessories?
D.3.29 Does the IVD medical device have a control interface?
D.3.30 Does the examination equipment or IVD medical device display information?
D.3.31 Has the IVD medical device been tested in relation with cybersecurity?
D.3.32 Is the instrument or IVD medical device controlled by a menu?
D.3.33 Can the user interface be used to initiate user actions?
D.3.34 Does the IVD medical device use an alarm system?
D.3.35 In what ways might the IVD medical device be deliberately misused?
D.3.36 Does the IVD medical device or the LIS hold data critical to patient care?
D.3.37 Is the IVD medical device intended to be mobile or portable (e.g., for point of care applications)?
D.3.38 Are specimens adequate for the examination procedure?
D.3.39 Are personnel trained and periodically monitored in the use of equipment?
D.3.40 Are turnaround times (TAT) adequate during operational processes?
D.3.41 Are quality control processes adequate to assure quality of examination results?
Annex E
E.1 General
E.2 Identification of hazards
E.3 Hazards to the patient
E.4 Hazards from fault conditions
E.5 Hazards due to use error
E.6 Hazards in correct use
E.7 Hazardous situations
E.8 Examples of known and foreseeable hazards
E.9 Examples of initiating events and circumstances
E.10 Examples of relationships between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur
Annex F
F.1 General
F.2 Nonconformities associated with the core medical laboratory
F.2.1 Pre-examination phase
F.2.2 Examination phase
F.2.3 Post-examination phase
F.3 Nonconformities associated with the anatomical pathology laboratory
F.3.1 Pre-examination phase
F.3.2 Examination phase
F.3.3 Post-examination phase
F.4 Nonconformities associated with the transfusion medicine laboratory
F.4.1 Pre-examination phase
F.4.2 Examination phase
F.4.3 Post-examination phase
F.5 Nonconformities associated with the microbiology laboratory
F.5.1 Pre-examination phase
F.5.2 Examination phase
F.5.3 Post-examination phase
F.6 Nonconformities associated with the molecular laboratory
F.6.1 Pre-examination phase
F.6.2 Examination phase
F.6.3 Post-examination phase
F.7 Nonconformities associated with chemistry, haematology or haemostaseology laboratory
F.7.1 Pre-examination phase
F.7.2 Examination phase
F.7.3 Post-examination phase
F.8 Nonconformities associated with the pre-analytical phase
F.8.1 Pre-laboratory receipt phase (generally the responsibility of the healthcare provider)
F.8.2 Post-laboratory receipt phase – specimen accessioning
F.8.3 Post-laboratory receipt phase – data entry
F.9 Nonconformities associated with information technology
Annex G
G.1 General
G.2 Preliminary Hazard Analysis (PHA)
G.3 Fault Tree Analysis (FTA)
G.4 Failure Mode and Effects Analysis (FMEA)
G.5 Process FMEA
Annex H
H.1 Categories of user action
H.2 Examples of use errors, abnormal use and possible causes
H.2.1 Examples of use errors
H.2.2 Examples of abnormal use
Annex I
I.1 General guidance
I.2 Estimating the probability of harm
I.3 Estimating risks when the probability cannot be estimated
I.4 Estimating the severity of harm
I.5 Estimating the risk of harm
I.6 Examples
I.6.1 Risk assessment example
I.6.2 Corrective or preventive action decisions
Annex J
J.1 Overview
J.2 Overall residual risk evaluation
Annex K
K.1 General
K.2 Benefit estimation
K.3 Criteria forbenefit-risk judgments
K.4 Benefit-Risk comparison
Annex L
L.1 General
L.2 Disclosure of residual risk
Bibliography
Cited references in this standard