ISO 15189

Question 1

What is the id number for the current version

Answer 1

ISO 15189:2022 Standard

Question 2

what does the ISO 15189 Show? and when was it first published - include revision republishent dates

Answer 2

shows requirements for quality and competence of medical labs
- first published 2003, republished - 2007, 2012, 2022

Question 3

how are irish labs accredited

Answer 3

INAB accredits Irish labs according to ISO 15189

Question 4

What does shall, should and may mean in this document. how many pages are the requirements and total document

Answer 4

it means its a requirement, its a recommendation and its permitted
-requirements = 34 pgs
-total -64

Question 5

what are the subsections of this document

Answer 5

1. SCOPE
   
   2. NORMATIVE REFERENCES
   3. TERMS + DEFINTIONS
   4. GENERAL REQUIREMENTS
   5. STRUCTURAL + GOVERNANCE REQUIREMENTS
   6. RESOURCES REQUIREMENTS
   7. PROCESS REQUIREMENTS
   8. MANAGEMENT SYSTEMS REQUIREMENTS
2. Annexure -A. POCT B. Comparision with ISO 9001: 2015; ISO 17025: 2017 C ISO 15189: 202

Question 6

what is the main objective of the ISO 15189

Answer 6

• Promote welfare of patients + and satisfaction of lab users through confidence in the quality and competence of medical labs

Question 7

the document shows the requirements for the med lab to plan and implement what?

Answer 7

actions to address risks and opportunities for improvement - no more 0 tolerance some things can be tolerated - hence risk assessment must be done on everything

Question 8

what are the benefits of the new some tolerance approach of the new standard

Answer 8

increase effectiveness of the management system, decreasing probability of invalid results, reduce potential harm -> patients, lab personel, the public and the environment

Question 9

medical lab responsibility in relation to the patient

Answer 9

activities should done in timely manner and needs of all patients and personnel responsible for patient should be met

Question 10

what does clause 4 entail and list its first 3 subsections

Answer 10

General requirements
4.1. lab activites undertake impartially
4.2 confidentiality
4.3 requirements regarding patients

Question 11

what does clause 4.1 cover

Answer 11

the lab activites undertaken impartially meaning the lab is structured and managed to safeguard impartiality

Question 12

clause 4.2 entails

Answer 12

confidentiality - 4.2.1. management of info obtained
4.2.2 release of info
4.2.3 personnel responsibility

Question 13

what does clause 4.3 entail

Answer 13

requirements regarding patients
- Lab management shall ensure that patients well-being, safety + rights are the primary consideratiosn
- Lab implement processes a-> I in ISO 15189
- E- treat patients, sample with due care and respect i.e. proper disposal
H- making info available

Question 14

what is a NC and a NCR

Answer 14

non-conformities as defined by ISO standard is the nonfulfillment of requirements and therefore is when a purpose/ activity has not fulfilled it intended use

Question 15

what is the difference between quality policy and quality manual

Answer 15

QP- defines intent use for the QMS and ensures its appropriate for its intended purpose
QM incorporates the QP/references it - it describes the scope, structure and relationship of documents used in QMS

Question 16

Explain difference between Ca and Pa

Answer 16

corrective action- action to eliminate the root cause of the problem causing a Non-conformity. Preventive action- proactive process used -> identify opportunities for improvement

Question 17

CLAUSE 5 OF THE ISO 15189 COVERS? lsit first 4 subsections

Answer 17

Structural and government requirements
5.1 legal entity
5.2 lab director
5.3 General
5.4 Structure and authority

Question 18

describe clause 5.1

Answer 18

Legal entity
- Lab can be held legally responsible

Question 19

explain clause 5.2

Answer 19

Lab director - has ultimate responsibility, they implement the management systems, risk management [patients risk and opportunities -> improve

Question 20

explain 5.3 and all it entail

Answer 20

Lab Activities
5.3.1 General
- Range of lab activitives
- Include activities @ sites other than main location i.e. POCT and sample collection
5.3.3 Advisory Activities
- Appropriate advice + interpretations = available + meet needs of aptients and users
- –Lab establish arrangements for communicating with users e.g.g - choice + use of examinations [sample type, clinical indications, limitation of examinantion methods]
- –advise on failure of samples -> meet acceptability criteria [i.e. tell doctor when look for a next step test how to label bottle to ensure sample doesn’t fail and is rejected

Question 21

explain 5.4 and all it entails?

Answer 21

General
Organisation and management structure should be defined in a lab
Should define place in any parent organisation
Defien relationships between management, technical operations and support services
Specify respon. Authority, lines of communication + interrelations of all personnel

Question 22

effective leadership and management on practice results in what?

Answer 22

success is achieved and better patient care

Question 23

the organisation structure must ?

Answer 23

assure quality goals

Question 24

list 4 benefits of leadership and management on practice

Answer 24

1. improve staff morale 2. increase productivity 3. promotes quality care 4. improves financial performance

Question 25

what is clinical government and what is there importance

Answer 25

is a framework through which healthcare teams are accountable for quality, safety and satisfaction of patients they deliver care to. helps ensure people receive care they need in a safe, nurturing and open + just environment which arises from corporate accountability for clinical performance

Question 26

what is the role of clinical

Answer 26

ensures a culture + commitment to agreed service levels and quality of care to be provided

Question 27

benefits of clinicial governance

Answer 27

improved patient experiences + better health outcomes in terms of quality and safety

Question 28

what role do lab results play in clinical decision making

Answer 28

diagnosis, prognosis and monitoring

Question 29

what are the principles of conflict management - CARE

Answer 29

C- Communicate A- actively listen R- review options E- end with a win-win sitch

Question 30

What does clause 5.5 cover

Answer 30

objectives and policies ---- policies are established and maintained to: 1. Meet needs + requirements of its patients + users 2. Commit -> good profess 3. provisional practice 4. Provide examinations that fufill their intended use 5. Conform -> ISO 15189:2022 - Shall be measurable [i.e. rejected samples -. Those received TAT - Establish quality indicators to evaluate performance [pre-examination, examination and post examination processes

Question 31

what does clause 5.6 entail and how is its titled achieved

Answer 31

risk management maintain processes - Identify risks of harm to patients - Opportunities for improved patient care

Question 32

what does ISO 22367 detail and what does ISO 35001 entail

Answer 32

provide details for managing risk to med labs 35001 gives details for lab biorisk management

Question 33

CLAUSE 8 covers ? name first 5

Answer 33

managment system requirements 8.1 general 8.2 management system documentation 8.2 control of management system documents 8.3 control of records 8.5 actions to address risks and opportunities for improvement

Question 34

describe clause 8.2 and what it does

Answer 34

MANAGEMENT SYSTEM DOCUMENTATION - Establish document, implement and maintain a management system [QMS] - Persons doing work under lab control = aware of : 1. Relevant objectives and policies 2. Their contribution -> effectiveness pf QMS including benefits of improved performance Consequences of not conforming with QMS requirements

Question 35

describe clause 8.3 and what it entails

Answer 35

CONTROL OF MANAGEMENT SYSTEM DOCUMENTS Document: is editable and communicates info Policy statements, procedures + related job aids, flow charts, instructions for use, specification, manufacturer's instructions, calibration tables,

Question 36

HOW ARE INTERNAL AND EXTERNAL DOCUMENTS CONTROLED

Answer 36

- uniquely identified -documents = approved for adequacy by expertise, authorized and competent personnel - documents = periodically updated and reviews - relevant versions = available @ points of use [distribution control = put in place when necessary -changes + current revision status = identified -documents = protected from unauthorized access -unintended use of out of date documents = prevented + suitable id = put on them if they are retained for any reason - @ least 1 paper/electronic copy of each out of date/obsolete of document = retained for specified time period

Question 37

control of records facts x6

Answer 37

- Are created @ time of activity. - Uneditable - Retained - retention times specified# - Establish and retain legible records - Records must be accessible, legible or available for review - In any form or type of Medium

Question 38

procedures are implemented for? records

Answer 38

- ID - storage - protection form unauthorised use - back-up -archive -retrieval - Tr disposal of records

Question 39

management reviews occurs when

Answer 39

@ planned intervals- it reviews the management system

Question 40

list review inputs

Answer 40

- meeting minutes actions - objective + suitability of policy and procedures -inspections i.e. trend analysis -user feedback -complaints -risk and opportunities for improvement -vendor review -external quality assurance -departmental statistics

Question 41

how are the outputs reviews

Answer 41

a record of the decisions / actions are made - check and ensure actions = completed within specified time frame -communicate actions and decisions to all lab personnel