Part Two Flashcards
What is accreditation?
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.
What is certification?
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.
What areas are covered in laboratory accreditation?
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
What components of the quality management system are assessed in the accreditation process?
- 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
How to prepare for an accreditation visit?
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
What is the pathologists role in accreditation- on the assessor end?
● Conduct ● Confidentiality ● Conflict of interest ● Requirements ● Standards vs guidelines ● Evidence based vs expert opinion ● Acceptable vs ‘best practice’
What is an audit?
The systematic and critical analysis of the quality of the laboratory service.
Discuss your approach to performing an audit
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
What is a horizontal audit? What is a vertical audit?
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)
What is good manufacturing practice (GMP)?
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.
What are the components of GMP in blood banking?
- 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
What is haemovigilance?
- 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
What do you do when an analyser fails?
- 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.
Discuss potential ways in which you can reduce expenditure in the lab
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
What to do if a histology or blood or bone marrow specimen is not labelled correctly
- 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
List the reasons why a cross match sample may be rejected by blood bank
- 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
What information do you need to give to potential LIS vendors?
- 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.
What are the important factors that make a LIS desirable?
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.
How to choose the right LIS for your lab
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
What are the main types of hazards encountered in pathology laboratories?
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
What are some ways of dealing with hazards in the laboratory?
- Hazard identification
- Risk assessment: for recognisable and predictable hazards: risk matrix = likelihood vs consequences
- Risk control: elimination –> substitution –> engineering –> administration –> PPE
What information should be present on the material safety data sheet?
- 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
What are some of the ways that lab acquired infections can be prevented?
- 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
What is the difference between a biosafety cabinet and a fume hood?
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.
What is the blood/ body fluid accident procedure?
- 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.
How do you deal with a biological spill?
- Report spill to supervisor / safety officer
- Inform other staff in the area - may need to evacuate the area or cordon off the area
- Always wear PPE - plastic apron, gloves, eye protection and mask if not inside a biological safety cabinet
- Always treat the spill as if it were infectious
- Limit / Clean up the spilt material
a. Remove sharp objects with forceps
b. Wipe material towards centre
c. Try to avoid creating aerosols - Disinfect all surfaces - Trigene
- DATIX Incident report
How do you decontaminate a centrifuge after a broken tube?
- Inform safety officer
- Put a sign on centrifuge to indicate it is out of order/equipment is contaminated.
- Wait 60 minutes after the centrifuge has stopped operating to initiate clean-up. This allows aerosols to settle.
- Put on lab coat, gloves and a face shield prior to opening centrifuge. Open carefully to assess the damage.
- 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).
- 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.
- Spray the interior of the centrifuge chamber with a disinfectant, let sit for 20 minutes and then wipe down.
- Dispose of all biological waste appropriately
- Incident report - DATIX
