Part Two Flashcards
1
Q
What is accreditation?
A
The procedure by which an authoritative body gives formal recognition that an organisation is technically competent to carry out specific tasks, and has sound quality systems. Accreditation is done through the application of recognised standards as defined in ISO 15189.
2
Q
What is certification?
A
Procedure by which an independent body gives written assurance that a product, process or service conforms to specific requirements. Look for evidence of compliance with standards, policies, procedures, requirements and regulations.
3
Q
What areas are covered in laboratory accreditation?
A
Follows ISO 15189:
1) Management/ organisation
2) Staff/ personnel
3) Environment/ safety
4) Equipment, reagents and consumables
5) Testing: pre-analytic, analytical and post-analytical
6) Quality management system
7) Records, reports and lab information management system
4
Q
What components of the quality management system are assessed in the accreditation process?
A
- Management and organisation
- Quality policies and manuals
- Quality and technical records (training, competence, calibration, maintenance)
- Document control (policies, SOP)
- Internal QC and EQA
- Identification and control of nonconformities (processes for corrective and preventative actions)
- Advisory services (pathologist available for advice)
- Evaluation and audits
- Complaints handling process
5
Q
How to prepare for an accreditation visit?
A
Preparation:
1) Ensure all the right people are aware of the up coming accreditation and involved in the process: lab director, relevant managers, section heads, quality officer/ quality assurance coordinator for each department, pathologists.
2) Ensure everyone is aware of their roles and responsibilities
3) Ensure that people are familiar with the processes involved in accreditation and revise the standards that need to be met (ISO 15189)
4) Review previous accreditation reports - ensure non-conformities have been addressed.
5) Review documentation
6) Review audit procedures and results
7) Review quality assurance procedures (QC, EQA etc…)
Have meetings:
1) Review supervision procedures in the lab- how is supervision performed? When? How often and by who?
2) Review services available- routine vs after hours
3) Review test range and numbers- which assays are performed inhouse vs send-aways. TAT.
4) Review personnel- numbers, competency, qualifications etc…
5) Review methods and equipment
6) Review reporting/ LIS system
On assessment day:
1) Be there, be involved
2) Offer support
3) Clarify and explain
4) Discuss roles
5) Explain known differences
6
Q
What is the pathologists role in accreditation- on the assessor end?
A
● Conduct ● Confidentiality ● Conflict of interest ● Requirements ● Standards vs guidelines ● Evidence based vs expert opinion ● Acceptable vs ‘best practice’
7
Q
What is an audit?
A
The systematic and critical analysis of the quality of the laboratory service.
8
Q
Discuss your approach to performing an audit
A
1) Identify the issues and goals of the audit
2) Obtain/ define the standards
3) Collect data of current practice
4) Compare to the standards
5) Plan and implement the necessary changes
6) Re-audit
9
Q
What is a horizontal audit? What is a vertical audit?
A
A horizontal audit examines one element in a process on more than one item.
A vertical audit examines more than one element in a process on one item (checks each step of the specimen’s journey through the laboratory from registration to reporting)
10
Q
What is good manufacturing practice (GMP)?
A
Term used to describe the systems manufacturers of medicines are required to have in place to ensure their products are consistently safe, effective and of acceptable quality.
11
Q
What are the components of GMP in blood banking?
A
- Quality management
- Personnel
- Premises and equipment
- Documentation
- Production: activities follow defined procedures, by trained competent staff
- Q C: involved in all decisions; sampling as per written procedures; analytical methods validated
- Complaints and product recall; incident management
- Internal audit: confirm standards are being met, identify problems/ opportunities for continuous improvement
12
Q
What is haemovigilance?
A
- Co-ordinated surveillance of blood and blood products from donors to recipients “vein to vein”.
- Quality activity
- Transfusion community needs data to be able to undertake continuous process improvements and hemovigilance is the way that we get that data
• Comprises surveillance of
1) Donor:
○ Donor demographics
○ Donor viral infections
2) Manufacturing
○ Process control of the manufacturing of components
3) Issuing
○ Sample labelling
○ Component utilisation
4) Recipients
○ Adverse events in recipients
- Monitoring SAE rates with feedback loops to decrease the rate of events/ lead to systems with improved performance.
- Red cell sensitisation rates
○ Recipient demographics
○ Patient haemoglobin levels prior to transfusion
5) Other
○ Audits
13
Q
What do you do when an analyser fails?
A
- Assess the problem
- Consult relevant SOPs
- Inform charge scientist
- If outage is moderate or major then inform duty manager/wards (777 Alert)
- Email to all clinicians
- Important that only critical tests are performed during this time - What should be done in the interim?
- Can test be performed on another machine/analyser - is there a back-up analyser?
- Send all specimens to another laboratory
- Urgent tests - POCT ABG or send to alternate laboratory. - Get the problem fixed
- Technician
- New machine?
- May need to call in additional staff - Inform duty manager when problem is fixed and testing can resume as normal. Expect increased load initially.
- Incident report and review to prevent it happening again - lab meeting discussion.
14
Q
Discuss potential ways in which you can reduce expenditure in the lab
A
1. Staff/Personnel ● Increase automation ● Reduce over-time workers ● Increase part-time workers ● Staff working between sections / cross-disciplines
- Tests / Instruments / Equipment
● Discuss proper laboratory utilization with all staff and laboratory technicians.
● Update all laboratory workers on any changes in standard operating procedures
● Limit the number of revenue negative tests
● Batch tests whenever possible.
● Order supplies in bulk
● Determine which tests to perform in-house and which to send out to a reference laboratory. - Overheads / Indirect costs
● Building - lease, maintenance, upgrades, security, cleaning etc.
● Sustainability - large expense is power (fridges, ventilation, instruments etc). Need to have energy-saving plans
● Lab design - flexible work benches, offices etc. so the spaces can be used for more than one purpose
15
Q
What to do if a histology or blood or bone marrow specimen is not labelled correctly
A
- Irreplaceable vs replaceable
- What is the impact on the patient(s)
- Recollect sample if you can to confirm the diagnosis
- May get staff member to confirm they took the sample
- If unrepeatable specimen then might go as far as genetic testing
- Thorough investigation into what went wrong
- Incident report, review, reduce risk for future
16
Q
List the reasons why a cross match sample may be rejected by blood bank
A
- Patient’s name, hospital number (NHI) or date of birth on the request form and sample differ
- Signature or initials of the collector on the sample are different from those on the Specimen Collector Declaration section of the request form
- Signature of collector missing from both the sample and declaration section of the request form
- Unlabelled form or specimen
- Insufficient sample volume or incorrect sample tube
17
Q
What information do you need to give to potential LIS vendors?
A
- Assess needs and requirements of your lab
- Document workflows and optimise them before selecting LIS
- Develop a comprehensive request for proposal (RFP) - give each vendor the same information and time to respond
- Develop a demonstration script for LIS vendors and evaluate their demonstration objectively.
18
Q
What are the important factors that make a LIS desirable?
A
Rich features while being cost effective, user friendly and intuitive interface and the ability of the system to scale to your growing business.
The ideal LIS will incorporate H&S, machine maintenance, staffing, management, SOPs etc in addition to the test cycle. Everything will be linked together and managed within the one system.
19
Q
How to choose the right LIS for your lab
A
1) Requirements of your lab
- Sample tracking tool/ sample management (pre-analytical, analytical and post analytical)
- Instrument integration
- Inventory and equipment management
- Quality management system
- Administrative and financial requirements
- IT requirements, data management, electronic data exchange
- Security requirements
2) Budget and costs
3) Implementation
4) Ability of the system to evolve based on your future requirements
5) Support service
20
Q
What are the main types of hazards encountered in pathology laboratories?
A
1) Blood and blood products
2) Infectious substances
3) Sharps
4) Chemicals and noxious fumes
5) Physical hazards
6) Ergonomic injury
7) Fire
8) Electrical hazards
21
Q
What are some ways of dealing with hazards in the laboratory?
A
- Hazard identification
- Risk assessment: for recognisable and predictable hazards: risk matrix = likelihood vs consequences
- Risk control: elimination –> substitution –> engineering –> administration –> PPE
22
Q
What information should be present on the material safety data sheet?
A
- Identification of substance/hazard
- Composition information
- First aid measures
- Firefighting measures
- Accidental release measures
- Handling and storage
- Exposure controls/personal protection (eg skin, eye, respiratory)
- Physical and chemical properties
- Stability and reactivity
- Toxicological information
23
Q
What are some of the ways that lab acquired infections can be prevented?
A
- Standard precautions (Handwashing: routine and antiseptic, tying hair back, waterproof coverings over breaks in the skin, remove jewellery, no eating or drinking, PPE)
- Immunisation
- Laboratory design
- Safety cabinets
- Disinfectants
- Waste disposal
24
Q
What is the difference between a biosafety cabinet and a fume hood?
A
In a biological safety cabinet, contaminated air is passed through a high efficiency particulate air (HEPA) filter. Conversely, fume hoods have a strong exhaust pressure and lack filters.
25
What is the blood/ body fluid accident procedure?
1. Clean/irrigate affected area thoroughly with running water
2. Apply antiseptic
3. If still bleeding cover with plaster
4. Inform safety officer / manager / shift supervisor
a. They will do a risk assessment
b. ID team need to be contacted if patient is known to be HIV/HBV/HCV positive or if patient blood is unobtainable
5. Retrieve BBFA pack from laboratory - complete all fields
6. Provide a sample for baseline blood testing
7. Contact OHS - particularly if baseline HBV immune status unknown
8. Incident report - DATIX
9. Contact EAP if you would like supportive counselling.
26
How do you deal with a biological spill?
1. Report spill to supervisor / safety officer
2. Inform other staff in the area - may need to evacuate the area or cordon off the area
3. Always wear PPE - plastic apron, gloves, eye protection and mask if not inside a biological safety cabinet
4. Always treat the spill as if it were infectious
5. Limit / Clean up the spilt material
a. Remove sharp objects with forceps
b. Wipe material towards centre
c. Try to avoid creating aerosols
6. Disinfect all surfaces - Trigene
7. DATIX Incident report
27
How do you decontaminate a centrifuge after a broken tube?
1. Inform safety officer
2. Put a sign on centrifuge to indicate it is out of order/equipment is contaminated.
3. Wait 60 minutes after the centrifuge has stopped operating to initiate clean-up. This allows aerosols to settle.
4. Put on lab coat, gloves and a face shield prior to opening centrifuge. Open carefully to assess the damage.
5. If the spill is contained within a closed cup, bucket or rotor, spray the exterior with disinfectant (Trigene) and allow at least 10 minutes of contact time. Remove the carrier to the nearest biosafety cabinet (BSC).
6. Gather supplies needed, such as a sharps container for broken glass and bins filled with disinfectant and place into the BSC. Use forceps to remove broken glass and place directly into sharps container. Carefully remove any unbroken tubes and place into a bin filled with disinfectant for 20 minutes. Wipe carrier/bucket with disinfectant.
7. Spray the interior of the centrifuge chamber with a disinfectant, let sit for 20 minutes and then wipe down.
8. Dispose of all biological waste appropriately
9. Incident report - DATIX
28
What is the GHS?
Globally harmonised system for the classification and labelling of chemicals.
Developed by the UN to create a single global methodology for chemical classification and hazard communication using labelling and Safety Data Sheets (SDS). It gives users practical, consistent and easy to understand information on chemical hazards and helps them take the appropriate preventive and protective measures for their health and safety.
29
Infectious contamination prevention in the lab?
1. Laboratory Safety Management System
2. Safe system of work - laboratory design, work-space environment
3. Staff training and competency assessments
4. Important that there are laboratory rules and staff obey these.
5. Standard precautions
5. Hand-washing
6. Staff are immunised
7. Biological Safety Cabinets - HEPA filters - should be used for fresh tissue
8. Disinfectants
9. Waste disposal
30
What is containment and how is this applied in the lab?
The term "containment" is used to describe safe methods for managing infectious agents, or hazardous substances, in the laboratory environment where they are being handled or maintained.
The three elements of containment include:
1. Laboratory practice and technique
2. Safety equipment
3. Facility design
The hierarchy of hazard control as per the legislation is:
1. Elimination
2. Isolation
3. Minimisation
Applied in the lab through:
1. Laboratory Safety Management System
2. Safe system of work
3. Staff training and competency assessments
4. Important that there are laboratory rules and staff obey these.
5. Standard precautions
6. Hand-washing
7. Staff are immunised
8. Biological Safety Cabinets - HEPA filters - should be used for fresh tissue
9. Disinfectants
10. Waste disposal
31
List the important safety measures to be taken when handling chemicals
- Exposure should be minimised
- Follow protocols/ SOPs
- Identify hazardous chemicals and know what special warning labels mean.
- Refer to the SDS to learn specific hazards, special handling requirements and emergency and first aid requirements.
- Ensure ventilation is adequate for the chemical being handled and use a fume hood for any procedure which might result in the release of toxic chemical vapours.
- Avoid storing or handling food or beverages in storage areas, refrigerators, glassware or utensils which are used for laboratory operations.
- Use personal protective equipment and know the location of safety showers and eyewash stations.
32
List the important safety measures to be taken when storing chemicals
- Store on low shelves with lips or raised edges to reduce the possibility of a container falling off and to minimise leaks or spills should they occur.
- Storage on bench tops, open shelves or in fume hoods is inadvisable.
- Exposure to heat or direct sunlight should be avoided.
- Stored chemicals should be examined periodically for replacement, deterioration and container integrity.
- Store alcohol and other flammable chemicals in approved safety cans or storage cabinets at least 1.5 metres away from a heat source.
- Separate chemicals that are potentially incompatible
- Secure cylinders of compressed gases to a wall or counter and stored in well-ventilated, dry areas and away from corrosive chemicals, vapours, or sources of ignition.
- The storage of flammable liquids requires special procedures in accordance with SDS.
33
List the important safety measures to be taken when labelling chemicals
When a chemical is transferred from its original container, the new container must be labelled to indicate the identity of the contents and appropriate hazard warnings.
The label must include the following information:
● Name of reagent
● Reagent concentration
● Initials of person who prepared the reagent
● Date of preparation
● Expiration date
● Special storage requirements
34
How would you manage a large chemical spill in the laboratory?
1. Report the incident to the person in charge/lab safety manager
2. Alert others of the spill
3. Assist others who have been contaminated
4. Evacuate and secure the area and isolate individuals if exposed/contaminated.
5. Refer to SDS for chemical involved to guide procedure of clean up, hazards and disposal
6. If major spill and unsure about safety, activate a HAZMAT alert and follow SOP
7. Wait for medical/fire teams to arrive
8. Fill out incident report
35
How would you manage a small chemical spill in the laboratory?
1. Report the incident to the person in charge/lab safety manager
2. Alert others of the spill
3. Assist others who have been contaminated
4. Evacuate and secure the area and isolate individuals if exposed/contaminated.
4. Refer to SDS for chemical involved to guide procedure of clean up, hazards and disposal
5. Arrange for the safe cleanup of the chemical
- Locate spill kit and only use if safe to do so using two people and safety gear (goggles, gown, gloves, respirator)
- Use absorbent pads and socks to contain and mop up the spill
- Make sure the absorbent pad is the right material for the chemical (refer SDS)
- Double bag the material, seal off and label towels and socks while wearing personal protective gear
7. Disposal depends on the chemical involved
8. Fill out incident report
36
What are the advantages of POCT?
Reduced turnaround time ⇒ prompt therapy control
Reduced problems with specimen transport and identification
Testing is usually simple
Small volume
Convenient
37
What are the disadvantages of POCT?
Potential for inaccurate results and over-testing - due to issues with calibration and QC
Documentation of controls often poor
Relies on adequate staff training
Possible medicolegal and safety issues
Flags on benchtop analysers may be limited
38
Considerations when implementing POCT?
1) Pre-acquisition assessment
- Clinical need and alternatives
- Equipment and purchase options
- Staff and facilities
- Cost effectiveness/ cost benefit analysis
2) Performance assessment
- Technical: accuracy, precision, compatibility etc...
- Reagent characteristics and stability
- Health and safety
3) Implementation
- Reference ranges
- Training: manual, operator training/ education/ accreditation
- Documentation, transmission and retention of results
- Quality and backup, audits
39
How can you carry out internal QC on POCT?
a. Parallel testing with POCT and supporting laboratory
b. Electronic device inserted instead of a test strip
c. Manufacturer’s liquid QC materials instead of blood sample
d. If out of range get a second IQC sample. If also out of range, no further testing should be done until the problem is fixed.
40
What should be done if QC results are out of range for POCT?
1) Check the correct control materials.
2) Look at different controls (low, normal and high) ⇒ all out suggests systematic error
3) Re-run using fresh QC material along with existing QC material ⇒ both out suggests systematic error
4) Shut down POCT until fault has been corrected. Make a sign “Out of Order” and inform all staff.
- All tests to be performed in the main laboratory
- Review all tests performed after last normal QC and inform clinicians. May need to arrange repeats.
41
How to implement a new POCT
1. MDT
- POCT coordinator, Key Operator, Clinical nurse manager of ward/department
2. Pre-acquisition assessment - Identify the need for POCT
- New test/new methodology/ replace equipment?
- Screening vs diagnostic vs both
- Benefit analysis
- How many people will use it?
- Anticipated test volumes? (per day, per week etc.)
3. Performance assessment of the device(s).
4. Validation of methodology and test performance
5. Work out the results interpretation
6. Development of all SOPs, manuals, troubleshooting guides
7. Training of all users
8. Develop a monitoring and auditing program
9. Ensure the POCT system has QC and is part of the EQA program
10. Health and safety
42
List the preliminary steps you need to take when considering a new analyser?
1. Cost
2. Environment and physical requirements
3. Operation of the instrument
4. Assessment of safety
5. Staff training
6. IT requirements
7. Maintenance/ repairs
8. QC programme
43
What do you do as part of the technical evaluation/ performance assessment when setting up a new analyser?
1) Calibration
```
2) Validation
• Accuracy
• Precision
• Reference ranges
• Linearity
• Reportable ranges based on linearity
• Sensitivity and specificity
• Establish if there is any carryover
• Measurement of Uncertainty
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3) Physical requirements
4) Develop methods/ SOPs
5) Staff training
6) QC programme
7) Maintenance and servicing records
8) IT requirements
44
What factors should you consider when setting up a satellite lab?
1) Concept development, budget and timeline
2) Identify/define the population that will be served
3) Decide on tests that will be performed on site vs those that will be referred to the main laboratory and how the tests will be performed.
4) Instrument considerations
5) Staffing
6) Establish a quality management system
7) If there is a transfusion service, must have a haemovigilance program
8) Lab computer services
9) Accreditation/certification via external agency such as IANZ.
10) Actual set up
45
What are the important components to consider when trying to improve TATs
1) Test selection and order entry
2) Specimen collection and delivery
3) Accessioning (sample receipt to registration)
4) Testing
5) Reporting
6) Audits
46
What to do if someone complains about the TAT of a test
Involves an audit and investigation
1) Identify the team that needs to be involved in the investigation
2) Identify issues/what needs to be audited?
- How often are the delays happening?
- When? E.g. time of day, specific situations? Specific staff?
3) Identify standards - SOPs/guidelines and international standards
4) Comprehensive investigation/data collection
5) Compare data to standards
6) Identify areas for improvement and implement changes
7) Re-audit
47
What is method validation?
Confirmation by examination and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.
○ Specific intended use= defining an analytical requirement
○ Objective evidence= collecting experimental data
○ Confirmation= comparison of requirement with evidence
48
What is verification?
Provision of objective evidence that a given item fulfils specified requirements
49
What is a lab information management system?
Software system that records, manages and stores data for clinical laboratories
50
What are the key functions of the modern LIS?
1) Test ordering
2) Sample management and tracking
3) Communication with analysers/ automation/ middleware
4) Result entry and validation
5) Result reporting
6) Management and recording of notification
7) Data mining
8) Quality control and assurance
9) Inventory management
10) Administration
11) Billing
51
What are the key connections for the LIS
1) PC clients for staff to interact with the LIS
2) External databases for patient demographic information
3) Analysers
4) Middleware or standalone servers
5) HMS/ EMR
6) Scanners
7) Data backup devices
8) Output devices for result distribution
52
Discuss how you would set up a flow panel?
1) Determine the objective of the panel
2) Determine the antigens that should be targeted to meet the objective
3) Design the panel
○ May involve a literature search- Are there any validated panels/ methods reported?
○ Consider using combinations of fluorochromes that minimise spectral overlap
○ Couple low density or weak antigens with strong fluorochromes and vice versa
4) Validate/ verify assay and refine the assay
○ Develop a validation/ verification protocol
○ Perform compensation experiments
○ Voltage optimisation
○ Antibody titration
○ Defining sensitivity, lower limit of detection, lower limit of quantification, limit of blank, specificity, accuracy, precision, CV, measurement uncertainty
○ Establish the most appropriate denominator to use
○ Test 20- 30 normals
○ Testing often needs to be performed in conjunction with a reference laboratory
5) Ensuring on-going quality of the assay following validation/ verification
○ Standard operating procedures/ guidelines/ troubleshooting documents
○ Staff training and competency
○ Machine and PMT voltage calibration
○ QC (Rainbow beads, internal controls, fluorescence minus one)
○ Participation in external QC where available
○ Ensure minimum number of tests are performed to maintain ongoing proficiency (30- 50 tests per year for MRD assessment.)
○ Certification/ Accreditation
53
How would you go about setting up a new molecular test in your laboratory?
- Quality assurance is paramount when setting up a new diagnostic assay. This requires engagement with/ from your organisation (department/ section heads, quality department)
1) Define the clinical question/ objective
2) Design your test so that it answers the clinical objective
- Literature search- any validated tests in place? recommendations for other groups/ official bodies etc...
- What methodology (will depend on the mutation/ aberration that needs to be detected, sensitivity required)
- If PCR- what method of end point detection is most appropriate. What primers should be used? Are probes necessary?
- What controls are needed?
3) Are systems/ equipment already in place to enable use of your new assay?
- Staff levels/ training/ competency
- Regents and analysers (including availability with other already established testing in your lab)
- Pre- post PCR set-up to minimise contamination
4) Draft a validation protocol
- Outlines objective and analytical method
- Defines pre-acceptance criteria
- Perform validation procedure to determine sensitivity (LLoQ, LLoD), specificity, accuracy, precision, CV, measurement uncertainty
- Ensure pre-acceptance criteria have been met
- Often involves testing 20- 30 normals as well as abnormal samples
- Often requires involvement from a reference laboratory
5) Ensure continued QA of your procedure/ test
- Standard operating procedures/ troubleshooting documents
- Staff training and competency
- Performing minimum number of required tests per year to ensure ongoing competence
- Appropriate QC
- Participation in EQC
- Certification/ accreditation
54
How do you define a simple vs complex spill?
Defined by the nature of the chemical hazard, the volume involved and the environment of the spill.
Spills involving diluted chemicals up to 500mls or chemical spills involving relatively harmless chemicals may be treated as a simple spill.
Small spills up to 250mls of corrosive chemicals may be treated as a simple spill.
55
What are the important things to consider when replacing an analyser?
```
Purpose
Funding source
Tender process and requirements
Technical evaluation
Financial evaluation
Procurament and contract
Technical validation
IT validation
Staff training and documentation
Supervision
```
56
What technical validation is required for your haem analyser?
Throughput/ sample volume/ stability
Correlation/ linearity/flagging/ sensitivity/ specificity
RBC/Hb/Hct/indices
WBC/diff/ NRBC (optical/impedance/other)
Platelet (optical/impedence/fluorescent) and indices
Other – body fluid/ CSF/ precursors
Software and middleware (pt/QC/QA/help files)
Hardware (maintenance/reagents/stores/temp)
Slidemaker/stainer – open/closed
Efficiency
57
What technical validation is required for your coag analyser?
Throughput/ tube type/ sample volume/ dead volume
Linearity/ interferences/ technology/ stability
Clotting tests/chromogenic tests/ immunological tests/ wavelengths
Aggregometry/ derived fibrinogen
Sample handling/ reagent handling/ shelf life
QC – Westgard rules – shift, drift, random error
Alarm and stop criteria – visual/audible/remote
Set QC limits – clinical limit or 2SD
Reagent selection – APTT/INR
Correlation with other tests? (e.g. activated protein C and FVL)
Reference ranges
58
What is clinical governance?
A framework through which organisations are accountable to continue to improve the quality of the service and safeguarding high standards of care by creating an environment in which excellence in clinical care would flourish.
59
How to set up TAT targets?
- The total TAT for laboratory assays includes the entire interval from ordering of the test to the clinician's awareness of the result (ie, “brain-to-brain”).
- Hospital vs community lab???
- Each step has a minimum or fastest time possible
- Look at standards
- Number of samples received/work volume, how many urgent vs routine samples per day
- Take into account clinician expectations
60
How is the tail size defined when measuring TAT?
Tail size can be quantified as the percentage exceeding a defined time (outlier rate) or as the time corresponding to a defined percentile of the distribution (e.g. 90th).
61
What is the pathologists role in managing a lab in times of crisis?
- Part of the leadership team (along with executives, managers, clinical pathologists, technical section heads, clinicians, and safety experts)
- Active role in planning, advising and implementing changes.
- Keeping up to date with the evolving evidence, developments and recommendations that come from multiple difference sources including the WHO, government agencies such as the MoH, authoritative bodies, expert opinions and advice.
- Providing team members with this reliable, evidence-based information in a clear, professional and ethical manner.
- Provide confidence and support in teams.
62
What are some examples of solvents used in the lab?
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Acetone
Formaldehyde
Toluene
Methanol
Ethanol
Phenol
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63
What are some examples of acids used in the lab?
Acetic acid
Carbonic acid
Hydrochloric acid
Sulphuric acid
64
What are some examples of alkalis used in the lab?
```
Ammonia
Potassium hydroxide
Sodium carbonate
Sodium hydroxide
Trisodium phosphate
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65
What is risk management?
| What is the ERM and what areas of medical care does the ERM cover?
Risk management in healthcare comprises the clinical and administrative systems, processes, and reports employed to detect, monitor, assess, mitigate, and prevent risks.
"Enterprise Risk Management" (ERM) assess risk across 8 domains
1) Operational (overall coordination of processes required for the creation and distribution of products and services in healthcare)
2) Clinical & Patient Safety
3) Strategic
4) Financial
5) Human Capital
6) Legal & Regulatory
7) Technological
8) Environmental- and Infrastructure-Based Hazards.
66
What are the Key Components of Performing Risk Management in Healthcare?
1) Identify risk
- Use of data, institutional and industry knowledge, and by engaging everyone can uncover threats and potentially compensatory events that otherwise would be hard to anticipate.
2) Quantify & Prioritize Risk
- Score, rank, and prioritize risks based on their likelihood and impact of occurrence and then allocate resources and assign tasks based on these measures.
- Uses risk matrices and heat maps
3) Invest in a Robust Risk Management Information System (RMIS)
- Provide tools for documenting incidents, tracking risk, reporting trends, benchmarking data points, and making industry comparisons
4) Investigate & Report Sentinel Events
5) Deploy Proven Analysis Models for Incident Investigation such as a RCA
6) Think Beyond the Obvious to Uncover Latent Failures
7) Capture & Learn from Near Misses & Good Catches
8) Perform Compliance Reporting
67
What is benchmarking and what steps are involved?
Benchmarking is when you compare local laboratory quality to an external quality standard drawn from studying many laboratories or a few best performers.
1. Select a process
2. Identify benchmark or reference point
3. Collect and organise available internal data
4. Identify gaps and compare your data to benchmark
5. Develop goal and metrics
6. Engage laboratory staff
7. Take action and manage the project
8. Monitor and share progress both internally and externally.
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What steps should you take when QC is out of range?
• Established policies/ procedures for troubleshooting should be in place.
1) Stop issuing results/ loading new sample
2) Check all components of the test system (QC material, reagents, instrument)
3) Take corrective action
4) Once potential sources of error have been identified and corrections have been made, the control sample should be rechecked.
4) Determine the effect on already issued results
5) Retest as necessary (until a point of agreement between results is reached). The samples should be rerun along with another QC sample.
6) Correct results/ inform appropriate clinician
7) Document what has occurred
