Answers for Common Part 2 Questions Flashcards
How would you choose a new FBC analyser?
1) Review relevant SOPs, policies and institutional guidelines for procurement of a new FBC analyser
2) Form an MDT with the relevant and interested stakeholders: for a FBC analyser this would include clinical and laboratory Haematologists, managers, sections heads, laboratory technical staff.
3) Establish your budget
4) Develop a business case
- Why do you need a new analyser (old/ out of date machine, increased throughput required, new technology, safer technology (i.e. cyanide free Hb measurement) etc….
5) Assess different machines looking specifically at:
i) Cost
- Capital cost over life of the instrument
- Purchase outright vs loan
- Operational costs for consumables and reagents
- Maintenance contracts
- Labour costs
- Cost per test vs cost per test reported
ii) Operation of the instrument
- How is haemoglobin, Hct, NRBCs measured? How is the WCC diff performed? What options are there to measure platelet count (optical vs impedance)?
Which parameters are measured directly vs which are calculated?
- CSF/ body fluid mode?
- Machine specs (accuracy, precision, reportable range, linearity etc..)
- How simple/ difficult to run
- Automated vs manual
- Throughput
- Ease of in-house maintenance
iii) Physical requirements
- Size, power/ voltage requirements, water, compressed air
iv) Environmental concerns
- Waste and waste disposal
iv) Assessment of safety
- Closed analytical system? Cap piercing technology?
v) Staff training
vi) IT requirements
- Compatible with LIS and current middleware? Need for additional middleware?
- Flags, critical alert settings, rules for blood films to be made
- Compatible with cellavision?
vii) Maintenance/ repairs/ servicing/ support
viii) Validation/ verification
ix) QC programme/ EQA
x) Accreditation/ compliance
How to choose a new LIS
1) Review relevant SOPs, policies and institutional guidelines
2) Form an MDT with the relevant and interested stakeholders
3) Establish your budget
4) Establish your timeline
5) Develop a business case
- Why do you need a new LIS?
- What do you need your new LIS to do?
( Sample tracking tool/ sample management (pre-analytical, analytical and post analytical), instrument and middleware integration, inventory and equipment management, quality management system)
- Haematology specific: reflex testing, expert systems for automatic comments, rules for referral to Haematologist/ film to be made
- What are your administrative and financial requirements
- What are your IT requirements (data management, electronic data exchange)
- What are your security requirements?
6) Assess different LIS systems
- 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 proposal objectively.
7) Choose the best LIS for your lab by assessing:
i) Budget/ costs
ii) Rich features that meet your specified requirements for your LIS while being cost effective, user friendly and having an intuitive interface
iii) Implementation
iv) Ability of the system to evolve based on your future requirements
v) Support service
vii) Accreditation/ compliance
How would you go about setting up POCT?
1) Review relevant SOPs, policies and institutional guidelines
2) Form an MDT with the relevant and interested stakeholders (POCT coordinator, Key Operator, Clinical nurse manager of ward/department)
3) Establish your budget/ funding
4) Pre-acquisition assessment
- Clinical need and alternatives (new test/new methodology/ replace equipment)
- Screening vs diagnostic vs both
- Equipment and purchase options
- Staff and facilities
- Cost effectiveness/ cost benefit analysis
- How many people will use it?
- Anticipated test volumes? (per day, per week etc.)
2) Performance assessment
- Technical: accuracy, precision, compatibility etc…
- Reagent characteristics and stability
- Health and safety
3) Implementation
- Validation of methodology and test performance
- Work out the results interpretation
- Development of all SOPs, manuals, troubleshooting guides
- Training of all users
- Develop a monitoring and auditing program
4) Ensure the POCT system has QC and is part of the EQA program
6) Accreditation/ compliance
5) Health and safety
How do you manage complaints regarding turn around time?
The first step is to determine the scale and seriousness of the complaint. This often requires a discussion with the complainant and reviewing whether there have been additional complaints or incident forms filled regarding the issue:
- How often are the delays happening? Single event vs a widespread issue?
- Which tests are affected?
- When? E.g. time of day? specific situations? Staff?
- Have patients been adversely affected?
- What does the complainant consider the appropriate TAT to be for this test? Is this realistic? Is it in keeping with the lab determined TAT?
It also involves looking at objective evidence regarding TAT of the test in question:
- What have been the results of our internal audits regarding TAT (mean, median, tail size/ outliers)
- Have we had documented issues with overdue tests?
Answers to the above questions will determine the appropriate course of action. Any significant complaints regarding TAT requires an audit and investigation.
1) Determine the appropriate MDT to investigate the problem and be involved in the audit (pathologist, section head, scientists, quality)
2) Identify issues/what needs to be audited?
- What definition of TAT will we use?
- Ideally we want to measure both extra-laboratory and intra-laboratory factors that determine the TAT. This involves assessing the process from test ordering right through to the point in which the clinician accesses the result. (i.e a complete vertical audit)
- How is this best assessed: ideally prospective as extra-laboratory factors affecting TAT are often not accurately documented/ can be difficult to determine in retrospect.
3) . Identify standards
- Determine the ideal TAT for the test/ procedure
- Lab website, national or international standards, determine in conjunction with ordering clinicians
- Comprehensive investigation/data collection:
- How will data be collected? By whom?
- What data needs to be collected?
- Need for institutional sign off? Ethics (usually not necessary for an audit)? - Compare data to standards
- Identify areas for improvement and implement changes
- Pre analytic, analytic, post analytic - Discuss results of audits and recommendations with key stakeholders/ interested parties
- Re-audit
Blood and body fluid- what do you do?
- Clean/irrigate affected area thoroughly with running water
- Apply antiseptic
- If still bleeding cover with plaster
- 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 - Retrieve BBFA pack from laboratory - complete all fields
- Provide a sample for baseline blood testing
- Contact OHS - particularly if baseline HBV immune status unknown
- Incident report - DATIX
- Contact EAP if you would like supportive counselling.
- Clean any associated spill as per biohazard procedures
- If sample unusable- contact clinical team
The director of anaesthetics wants to buy a TEG for use in cardiac surgery. They want to know whether this can be operated and serviced by a blood bank scientists as blood bank is next to theatres. How would you advise?
- TEG is a point of care device: that is a device used outside of the main laboratory at or near the site of the patient.
- One of the main aims of POCT is to reduce turn around time to rapidly provide results that can immediately inform patient management.
- TEG is commonly used in cardiac surgery and there is an increasing literature base to support its use.
- I would advise the director of anaesthetics that:
1) There is a process to obtaining POCT within our hospital and that it is important that we understand and follow the SOP, policies and guidelines in place regarding acquisition of POCT
2) Pre-acquisition assessment is necessary in order to be able to draft a business case for a new POCT device. This involves setting up an MDT with stakeholders and interested parties.
- Why do we need POCT?
- What is the evidence base for POCT in this setting?
- Are there reasonable alternatives? What are our current practices?
- Has a cost benefit analysis been performed?
- What costs are involved (staff, machine, reagents)?
- Which department will pay/ where are the funds coming from?
- How will we define thresholds for transfusion?
- Practicalities of running POCT
The issue here is the request for a blood bank scientist to run the tests
- Will require additional training- is this feasible?
- What are the anticipated test volumes- do we have adequate staffing available at all shifts to perform?
- Can we guarantee that the requirement for POCT will not get in the way of safe and timely delivery of blood products?
- Are there any alternative staff from within anaesthetics/ theatres who could perform the TEG?
Once these issues are sorted, draft a business proposal. Once approved, can start choosing the appropriate analyser and implementing it.
How are TAT targets set and measured?
- Clear definition of what TAT means in your laboratory in terms of start and end points.
- Time points measured are largely dependent upon the LIS used and its interface with the HIS: extra-laboratory factors affecting the TAT are often not easily available. Using an “intra-laboratory” definition of TAT (receipt of sample to release of report) enables data to be collected easily, reliably and importantly- on an ongoing basis through the LIS (i.e. with data mining) and through audits.
- TAT target depends on setting (inpatient vs outpatient, ED/ ICU vs general ward), clinical urgency and the test ordered.
- Each test has a minimum or fastest time possible but this can be longer if there are delays.
- TAT targets are often set by looking at international consensus and guidelines set by reference laboratories
- These guidelines can also be assessed in the context of the individual laboratory and the needs of the clinicians requesting the tests and acting on the information (How often are tests performed? What is the throughput? Are the tests batched? How manual or automated is the test? What is a clinically acceptable TAT?)
- TATs in our lab are audited on a monthly basis through data mining performed on the LIS. We audit the median TAT, mean TAT and outliers/ exceptions (tail size). Lotus notes (our reporting system) flags the overdue samples. We also do at least one vertical audit a month where a test is picked at random and everything is checked including the TAT.
How to manage the laboratory during a pandemic
1) Specific role of the pathologist
- 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.
2) Risk analysis/ management
- Leadership team to perform extensive “what if” evaluations of laboratory operations, safety, IT, specimen handling and transportation, human resources, business development, and regulatory compliance to identify areas of potential risk and propose solutions or alternative options.
3) Plan
a) Reduce the risk of the infection spreading through the lab
i. Standard precautions, handwashing, PPE, social distancing, WFH options
b) How to manage staffing levels in the event of staff illness
c) Changes to laboratory operations
i. Routine workload may decrease if elective procedures etc are cancelled.
ii. May need to stop performing certain tests within the laboratory during the pandemic to allow concentration of resources to where they are required in the short term
iii. Increased workload is likely to be expected in some areas (i.e. molecular, microbiology)
iv. Upskilling of certain staff may be necessary
vi. Need for new analysers/ reagents etc…
- Particularly relevant to Haematology with the Covid-19 pandemic due to the requirement for staff with molecular training to be involved in Covid-19 testing
d) Changes in the supply chain
e) Changes in revenue/ finances
4) Stakeholder engagement and communications strategy
5) Staff welfare
What is a chemical hazard?
What are some examples?
A chemical hazard is a (non-biological) substance that has the potential to cause harm to life or health
Examples include:
- Solvents (ethanol, acetone, formaldehyde)
- Acids (Acetic acid, hydrochloric acid, sulphuric acid)
- Alkalis (Ammonia, potassium hydroxide, sodium hydroxide)
What are the procedures in the lab to reduce the risk of flammable chemicals?
- Flammable and combustible chemicals are distinguished on the basis of their flash points: flammable chemicals have a flash point below 37.8 °C, combustible between 37.8 and 93 °C.
- Always review the hazard labels on the product and the SDS.
- Always follow SOP, policies and guidelines within the lab
Storage:
- The quantity of flammable chemicals should be kept at an absolute minimum. Flammable chemicals should only be ordered in quantities that can be used within a few months.
- Must be stored in approved safety cans. Keep container tightly closed in a cool, dry, well ventilated place out of direct sunlight and away from heat and ignition sources: ideally in a flammable storage cabinet.
- Storage on bench top, open shelves or within a fume hood is inadvisable
- Separate chemicals that are potentially incompatible and that might react with one another to produce an explosive, toxic, or flammable product
- Stored chemicals should be examined periodically for replacement, deterioration and container integrity.
Handling:
- Minimize the release of flammable vapours
- Eliminate or control other sources of ignition and heat in the laboratory
- Never use open flames in the same area where flammables are being used
- Minimize the amount of combustible materials (e.g. paper) in the vicinity
- Use fume hoods whenever possible, particularly when transferring or heating flammable liquids always for flammable gases.
- Only use non-sparking tools
- Use only electrical, ventilation and light equipment that is labelled as explosion proof
- Wear appropriate PPE: gloves, protective clothing, eye protection, face protection
- Make sure you have the proper extinguishing media in the vicinity of the operation
- Know what to do in the event of a spill or other adverse event such as a fire
- Know the location of safety equipment (eye wash stations etc…) and spill kits
- Know procedure for cleaning up a chemical spill
What does biohazard mean?
What procedures are in the lab to reduce risk to health and safety from biological samples?
The term biohazard refers to any biological materials that pose a threat to the health of living organisms.
- Laboratory Quality and Safety Management Systems
- Safe system of work/ culture within the lab that sees H&S as a priority and an important part of laboratory work
- Staff training and competency assessments
- Know and obey rules of the lab (i.e. no food or drink except for in designated areas)
- Always follow SOP, guidelines and documentation when performing procedures
- Hand washing (aseptic vs routine)
- Standard precautions (tie long hair back, closed shoes, cover cuts with a water proof dressing)
- Wear correct PPE for the correct procedure
- Know which samples must be handled in a biosafety cabinet
- Know which disinfectants need to be used when - Laboratory design:
- Work-space environment: placement of sharp bins to reduce sharps injury, location of biohazard bins and biosafety hoods.
- Use of automation (closed analytical system, cap piercing technology) - Occupational health and safety
- Staff are immunised against communicable disease (esp. Hep B)
- Clear procedures for blood and body fluid accidents within the lab
- Clear procedures for the clean up of a biological spill
- Clear protocols around waste disposal
How are acids stored/ handled in the lab?
(can also be used for questions about bases: both are corrosive chemicals (dehydrators and oxidisers are also corrosive chemicals))
- Take note of the hazard labels on the product and the SDS for information on handling and storing acids.
- Always follow SOP, policies and guidelines within the lab
- Know what to do in the event of a spill and have spill kits easily accessible
Storage:
- Strong acids should be stored in an appropriate container, in cool, dry place out of direct sunlight and away from heat and ignition sources: preferably in a corrosion proof safety cabinet designed for acids
- Storage on bench top, open shelves or within a fume hood is inadvisable
- Separate chemicals that are potentially incompatible and that might react with one another to produce an explosive, toxic, or flammable product
- Stored chemicals should be examined periodically for replacement, deterioration and container integrity.
Handling:
- Avoid generating vapours or mists
- Use appropriate PPE: chemical safety goggles and face shield when contact is possible. Wear chemical protective clothing e.g. gloves, aprons, boots for strong acids. May require respiratory protection depending upon the acid being used.
- Ensure adequate ventilation or use a fume hood where appropriate
- Immediately report leaks, spills or failures of the safety equipment
- Never add water to a corrosive (add the corrosive to water).
- If product is transferred to another container, ensure new container is suitable for the product. Never reuse empty containers .
What are the procedures in the lab to reduce the risk of compressed gasses?
Compressed gas cylinders are defined as any materials or mixtures in containers having an absolute pressure in excess of 40 psi at 20°C or in excess of 104 psi at 54.5
Compressed gas cylinders should be considered high-energy sources regardless of the type of gas and all should be treated as potential explosives.
Understand the hazard labels of cylinders of compressed air, read the SDS, always follow the SOP, policies and guidelines in place within the laboratory.
Storage:
1. Cylinders must be stored in designated storage areas away from ignition sources, corrosives, electrical supply sources and heat.
- Store oxidizers away from flammable gases. Oxygen and fuel gases must be separated by a distance of at least 7.6m or by a firewall. As an alternative, oxygen can be moved directly to the area of use.
- The valve protection cap must be kept on at all times, except when a cylinder is in use.
- Cylinders must be chained or strapped, or otherwise mounted, securely in place to prevent them from falling over. Cylinders must be individually mounted or strapped.
- Corrosive gases should be stored for the shortest possible time period: under three months is preferable.
- Cylinders may not be stored in areas not protected from the weather.
- Cylinders must be clearly labelled with the contents, by the vendor’s identification label. If labels are coming off, notify the Lab Manager immediately. Unlabelled cylinders cannot be returned to the vendor.
Handling:
Special training required: do not operate if you have not been trained.
- Handling and use of gas cylinders and lecture bottles
must comply with manufacturers’ recommendations. - Do not use flammable gases near exit paths.
- Wear safety glasses or goggles when installing or removing regulators on gas cylinders.
- Never use a wrench or other tool to open the valve unless the vendor supplies a special tool for that purpose. Use your hands.
- Never completely empty a cylinder. Leave a slight pressure (about 25 pounds) to keep out contaminates that may react with the contents or corrode the cylinder.
What are the procedures in place within the laboratory to safely handle and store formalin?
- Take note of the hazards labels on the product and the SDS for information on storage and handling
- Always follow SOP, policies and guidelines within the lab
- Do not handle until all safety precautions have been read and understood.
- Know what to do if there is a spill and have appropriate safety equipment accessible in the event of a spill
Storage:
- Store in a closed container in a well-ventilated area.
- Keep away from heat and direct sunlight.
- Store locked up.
- Can monitor formalin levels
Handling:
- Avoid contact with skin and eyes.
- Do not breathe mists/vapours/spray.
- This product should be used outdoors or in a well ventilated space designed specifically to be safe with formalin use.
- Do not eat drink or smoke when using this product.
- Wear adequate PPE: Safety glasses, gloves, sleeve protectors, gowns. Use a full-face respirator fitted with an organic vapour cartridge.
- Remove contaminated clothing and wash hands and face before entering eating areas.
How do you deal with a formalin spill?
1) If safe to do so: contain the spill (small spills: formalin absorbency sheet, larger spills Spill-X-FP granules)
2) Inform safety officer/ section head/ person in charge
3) Inform others in the area as they may need to evacuate
4) Refer to the SDS and SOP for formalin spill to get the following information:
- First aid measures if individuals have been exposed/ contaminated
- Definition of simple vs complex spill with this particular chemical
- Is evacuation necessary?
- Procedure for cleaning up a spill
5) If this is a complex spill: keep the area evacuated and activate HAZMAT alert- this will result in the NZ fire department being alerted to the spill and they will attend to help with the clean up.
6) If this is a simple spill then clean up the spill
a) Small spill (<70ml)
- Contain spill by covering with a formalin absorbency sheet
- Put on appropriate PPE
- Spray scavenger over/ near spill to neutralise fumes
- Ensure there is no specimen in the spill or stuck to the absorbency sheet
- Clean spill as quickly as possible using additional formalin absorbency sheets if necessary, discarding sheets into a appropriate chemical waste bag then tie bag off
- Wipe down the are with disinfectant
- Incident report
b) Large spill
- Use Spill-X-FP granules
- Put on appropriate PPE. A respirator mask must be worn
- The area must be evacuated
- Close off the area as best as you can
- Contain the spill by circling it with Spill-X-FP granules then cover all liquid
- Once all is absorbed, collect it into a chemical hazard bag, tie off and discard in a chemical hazard bin.
- Phone histology to monitor formalin levels in the area every 5- 10 minutes until the level is deemed safe to work in
- Incident report
