QC & QA Flashcards
The air quality in the IVF laboratory should be.
- Grade A on a background of Grade B
- Grade C on a background of Grade B
- Grade B on a background of Grade C
- Grade A on a background of Grade D
4.
air quality in IVF lab grade A → on background D
Embryo Culture is a Sterile Process
false
Gentamycin is the common antibioticused in culture media because…………….
It is more stable than penicillin
Washing Semen in culture media containing gentamicin………….
significantly reduces the bacterial load
Severe Bacterial Contamination Causes Embryo Death
true
which is NOT true regarding Culture Media Fungal Contamination
- Causes embryo death
- Does not appear to be embryo toxic at low levels
- Can still produce viable pregnancies
- Was the original observation that mouse embryos could grow in vitro
- Most likely originates from the egg recovery
- May become toxic at higher levels of contamination
1.
Contamination is more common in:
- IVF and ICSI
- IVF but not ICSI
- ICSI but not IVF
2.
Which Is True about contamination in the IVF LAB
- Shedding skin cells is the most likely cause of laboratory contamination
- Airborne contamination is 10 times higher inside than outside
- Walls and ceilings contain about 2-5 colonies per 25 cm2
- Floors contain about 380 colonies per 25 cm2
- Basic cleaning can reduce the contamination by 80%
- Disinfectant can reduce contamination by up to 95%
- HEPA filters can reduce airborne contamination
all correct
Which of the following are NOT true Regarding the effects of light on IVF systems?
- There is conclusive data confirming light is harmful to human gametes and embryos
- There is significant information that light effects non-primate gametes and embryos
- Light can effect oil
- Light can effect HSA
- Light can effect buffers
1., 4
regarding CM Which optic Colors are the most harmful for embryo development
- Red
- Orange
- Yellow
- Green
- Blue
- Indigo
- Ultraviolet
5, 6, 7
Its evidence that light can induce the formation of ► hydrogen peroxide (H2O2) in media containing HEPES and Riboflavin
true
► Riboflavin (also known vitamin B2)
Regarding wavelength, which is generally considered to be true
Higher wavelengths (600+) are good
A green filter is the best option to remove blue and infra-red wavelength
Light has been linked to the production of reactive oxygen species by……
phot-oxidation of membrane lipids
Reducing ROS can applied by:
- Reducing exposure to high risk wavelengths
- Be conscious that some buffers like HEPES after exposure generate photo-toxicity
- Use solution that contain high concentrations of ROS Scavengers
- Be aware that oil can be sensitive to photo-oxidation
1.3. 4
What is the wavelength used for the embryoscope
- 435 nm
- 535 nm
- 635 nm
- 735 nm
3.
The Main Source Of Toxic Light in the IVF lab mostly is:
- Microscopes
- Incubators
- Ambient light
1
(Review Article)
A Dangerous low level of oxygen is……..
17%
The basis for most control Charts is
- The mean of a set of data
- The standard deviation of a set of data
- The mean and the standard deviation of a set of data
3.
To create a Control Chart you need to:
To create a Control Chart you need to:
Identify a set of data you consists represents your current or desired
Calculate the mean and the SD of the data.
Create a graph plotting the data from any other data set SD from the mean
Identify any data that violates the Westgard rules for analytical laboratories
A Control Chart and Levey Jennings Charts Differ by……….
Control charts-are primarily used to monitor a process and determine if it is stable and under control and identify common cause of variation in general.
-plot the Sd from the mean and actual value
-specific for the topic being plotted
Levy Jenning-designed for monitoring the performance of a laboratory test or measurement system, More specific to analytical instrument performance in clinical laboratories..
plots only the SD from the mean value
You can plot more than one data set on a Levey Jennings Plot
According Basic Statistics - which is true?
- SD is a statistic that quantifies how close numerical values are in relation to each others.
- A sample with a low SD has low imprecision
- A sample with a high SD has high imprecisions
all true
The main Decision Limits are:
One SD : proportion of samples lie within 68%
Two SD :proportion of samples lie within 95.5%
Three SD: proportion of samples lie within 99.7%
How many samples will lie outside of 3SD by chance
- 1/1000
- 2/1000
- 3/1000
- 4/1000
- 5/1000
3.
The types of errors that a Levey-Jennings plot can identify include
Systematic errors
Random errors
Random Errors
- are any deviation away from an expected result
- can be either a positive or a negative variation from the calculated mean
- are only a negative deviation from the mean
- All random errors must be acted upon
- All random errors should be ignored
1 and 2
Random Errors above 1 SD
- may be expected to occur by chance
- indicate system failure
- indicate a wait and review response
1 and 3
Random Errors above 2 SD
- may be expected to occur by chance (~1/20 times or once every 20 months)
- indicate system failure
- indicate a wait and review response but follow the Westgard rules for action
1 and 3
Random Errors above 3 SD
- may be expected to occur by a very rare chance (~1/330 times or once every 30 years)
- indicate system failure
- indicate a wait and review response.
- indicate an immediate response.
1, 2 and 4
Systematic Error
Systematic Error
can be identified by a change in thee mean value
can by a gradual trending upwards or trending downwards
can be a sudden shift to a new mean value
trends and shifts can be identified by using Westgard Rules
A Systematic Error that is a trend may occur:
A Systematic Error that is a trend may occur:
Ageing of reagents
A change in equipment calibration
A change in personnel
A slow deterioration in the environment
A change in patient mix
A Systematic Error that is a shift may occur:
Change in reagents
Change in lot numbers of devices and consumables
External environment influences (eg roadworks, air conditioning)
Change in protocol or methodology
Westgard rules
The Westgard rules were developed in 1981 by Dr James Westgard as a basis:
for evaluating an analytical (biochemistry) run in medical laboratories
If Rule 1(2)S Occurs, which is true:
- This may be a random error
- This may be the start of a systematic error.
- You need to act on a rule 1(2)S infringement
- Should be noted and wait for a future test
- Considered a warning event
all true
On average, random errors may occur at a rate of:
- 1/100
- 1/50
- 1/25
- 1/20
- 1/10
- 1/5
4
Rule 1(3)S means any 1 observation is…..
more than 3 SD from the Mean
1(3)S rule infringement is……..
an unacceptable random error
It may be the start of a large systematic error
Rule 1(3)S and rule 3(1)S are
Rules that can use a single variable
A R(4)S Rule applies to
Two consecutive results more than 4 SD apart
Rule 4(1)S applies to a set of results where…
Four consecutive results on the same side of the mean greater 1 SD
true
Rule 2(2)S applies to
Two consecutive samples more than 2 SD on one side of the Mean
Key Personnel
Staff Must Include
the counseling,
nursing,
scientific
and medical Manager/Directors
The Medical Director from January 2015 must be:
- only a recognized specialist gynecologist
- only a physician
- An andrologist
- An endocrinologist
- Either a specialist gynecologist or a physician
- Either a specialist gynecologists or an endocrinologist
5
Where any of these personnel do not normally work on site, the clinic must be able to demonstrate at audit, regular involvement in
- clinical review
- quality control review
- staff attendance
- financial activities
- clinic activities
1 and 2
The Medical Director must have:
- has at least five years experience in that role
- can demonstrate substantial similar experience in the governance of an ART unit
- holds a Certificate of Reproductive Endocrinology and Infertility (CREI)
- any of the above
- any two of the above
- all of the above
4.
A Scientific Director with a PhD must have….
a minimum of four years of ART clinical laboratory experience
two years of experience in a managerial and/or supervisory role
A Serious Adverse Event
- is any event associated with ART treatment
- is any event associated with clinics activities
- is any event associated with staffing activities
1.
A Serious Adverse Event is any event associated with ART treatment which
causes or potentially causes harm to patients
causes or potentially causes harm to patients reproductive tissues
causes or potentially causes loss to patients
causes or potentially causes loss to patients reproductive tissues
causes or potentially causes damage to patients
causes or potentially causes damage to patients reproductive tissues
results in hospitalisation following, and as a result of, the treatment.
A Serious Adverse Event
needs to be investigated and be available for review at the next Certificate Body CB audit
true
A Serious Notifiable Adverse Event
- needs to be reported immediately to the RTAC
- needs to be reported immediately to the certifying body (CB)
- needs to be investigated and be available for review at the next CB audit
1 and 2
A Serious Notifiable Adverse Event is an event
only associated with an ART cycle
associated with fertility investigation prior to treatment
A Serious Notifiable Adverse Event may include
might result in the transmission of a communicable disease
might result in death
a life-threatening condition
a disabling condition
an incapacitating condition
a gamete identification error or mix-up
an embryo identification error or mix-up
Auditing of policies and procedures must occur at least
- monthly
- bi-monthly
- quarterly
- biannually
- annually
- Biennially
- Just before each accreditation review
5.
Traceability Includes
ejaculated sperm
surgically collected sperm
OCCC
immature oocytes
oocytes
embryos
discarded embryos
frozen embryos
surrogate embryos
transported embryos or gametes
research embryos (where permission has been granteed)
returning non-viable embryos to a person for disposal
CWA means
Critical work area
It is defined by each clinic in their Policies and procedures documentation
must be labelled with the patient’s identifiers
All containers and vessels must be labelled with the patient’s identifiers
A CWA contains only one person’s or couple’s sperm, oocytes, embryos or tissue at a time
The critical work area must be clear before use
CPI is
Critical Identification Points
Units must identify and document all the Clinics Critical Identification Points.
CPI Occurs When a Sample
- come into the unit
- change vessels
- change identity
- leave the unit
Clinics Need to have Policies and Procedures on the Management of
- Gonadotrophins used in ART
- GnRH antagonists and agonsists
- FSH and Clomid
- All drugs used in IVF
- All drugs supplied by the clinic
5,
The medication policies and procedures should include:
- Steps to ensure that drugs should not be used after their expiry date
- Steps to ensure that returned drugs should not be reissued
- Steps to ensure how returned but unopened drugs could be reissued
- Steps to ensure that drugs are safely stored
- Steps to ensure the safe disposal of unused drugs
1,2, 4 and 5
Policies should reflect that…………….
a maximum of two embryos for women under 40 year of age at collection
a maximum of two oocytes for women under 40 year of age at collection
a maximum of two embryos where the donor female was under 40 year of age at collection
a maximum of two oocytes where the donor female was under 40 year of age at collection
A serious adverse event:
a. needs to be reported immediately to the RTAC
b. needs to be investigated and be available for review at the next audit
c. needs to be reported immediately to the certifying body (CB)
b)
note:
RTAC: Reproductive Technology Accreditation Committee in AUSTERELIA
Activities that may cause a decrease in oxygen can include:
- a. filling dewars
- b. conducting audits
- c. Loading samples
- d. leaking dewars
- e. unloading or transferring samples
all
على اساس
conducting audit ► opening the LN2 tanks
Contamination is more common in:
a. ICSI but not IVF
b. IVF and ICSI
c. IVF but not ICSI
c)
CWA means:
a. common work area
b. critical work area
c. contagious work area
b)
Each change in a policy or procedure needs………….
Each change in a policy or procedure:
a. should be considered for auditing to confirm compliance
b. should be reviewed annually
c. needs to be registered on a master list of changes
d. needs documented proof each staff member it refers to has read it
e. to be authorized by a nominated and senior staff member
One liter of nitrogen will produce when heated to room temperature:
- a. 201 L of gas
- b. 301 L of gas
- c. 401 L of gas
- d. 11 L of gas
- e. 601 L of ga
- f. 101 L of gas
- g. 501 L of gas
e) 601
too much
75% alcohol used for :
a) Incubator decontamination
b) hands decontaminations
c) surface decontamination
d) equibment
c)
The use of 75% alcohol in an IVF laboratory:
-Not recommended for Incubator decontamination
-Limited use for hands decontamination
-Common practice for Surfaces decontamination
true or false
Cool Flourescent light is safe in the IVF LAB?
-Cool Flourescent light generates high levels of ROS
-while warm light is more safe
-wave length less than 300 nm can be absorbed by plastic dishes and more risky for gametes and embryod.
-Green filters on light source may reduce the light exposure
quality management system (QMS) is……………..
quality management system is the comprehensive system used by an organization to direct and control quality.
This includes all quality control (QC) and quality assurance (QA) activities in the lab.
Quality control (QC)
Quality control (QC) is part of the quality management system, which is focused on fulfilling specific quality requirements.
This includes activities such as testing products used in the lab with a mouse embryo (MEA) or human sperm assay (HSSA) to ensure that the products meet the laboratory specifications.
Quality assurance (QA)
Quality assurance (QA) involves assessing the extent to which quality objectives and requirements are being met.
For example, fertilization and pregnancy rates should be tracked to assess fertilization and pregnancy rates over time to identify deviations from the mean.
to avoid any errors or contamination in processing sperm in the Andrology lab…………..
- samples should be processed separately in time or space processing sperm one sample at a time or processing samples in different hoods.
- The sample container, tubes and processing documents should all labeled with the patient’s name and date of birth and all of these are checked by two different andrologists.
Internal audits
Internal audits include
-reviews of all the sections within the lab.
Problems should….
1- Identified
2- Documented in an electronic database
3- Reported to the departmental supervisor for correction.
More serious problems are also documented in the nonconformance database.
External Audits
External Audits performed annually by an independent organization.
-Certified auditors evaluate all aspects of the system and make recommendations for improvements.
Key PIs (KPIs) are indicators deemed essential for evaluating…
Key PIs (KPIs) are indicators deemed essential for evaluating…
objective measures for evaluating critical healthcare domains (patient safety, effectiveness, equity, patient-centeredness, timeliness and efficiency)
-represent an important element within the Quality Management System (QMS)
(.i.e)
-Minimum standards for proficiency; monitoring ongoing performance within a QMS (for internal quality control (IQC), external quality assurance (EQA)); benchmarking and quality improvement.
Vienna consensus identified three different types of indicators:
Total 19 indicators categorized in three types:
Reference indicators (RIs)
related to the oocytes coming into the laboratory, and so were proxy indicators of the response to ovarian stimulation only (2RI):
1- Proportion of oocytes recovered (stimulated cycles)
2-Proportion of MII oocytes at ICSI
PIs
PIs were those for which data should be documented and stored, even if they are not routinely reported in a control chart. (5PIs)
KPIs.
were those related to the ‘core business’ of the ART laboratory.(12KPIs)
Reference Indicator (RIs) for identifying performance of the ART laboratory.
-Proportion of oocytes recovered (stimulated cycles)
no. oocytes retrieved/no. follicles on day of trigger100 ………=80-95% of measured follicles
-Proportion of MII oocytes at ICSI.
no. MII oocytes at ICSI/no. COCs retrieved100……..=75-90%
True or false
Vienna consensus identified 5 performance indicators.
True:
-Sperm motility post-preparation(for IVF and IUI)
progressively motile sperm/all sperm counted × 100 ………………. (90% - ≥95% Benchmark)
——————————————–
-IVF polyspermy rate
no. fertilized oocytes with >2PN/no of COCs inseminated × 100 . (<6%)
—————————————————————
-1pN Rate (IVF)
No of 1PN Oocytes/no. COCs inseminated × 100 …….. (<5%)
—————————————
-1 PN rate (ICSI)
no. 1PN oocytes/no. MII oocytes injected × 100
……….(<3%)
————————————————————————-
-Good blastocyst development rate
no. good quality blastocysts on Day 5/no. 2PN/2PB oocytes on Day 1 ………..(90%)
what are daily, monthly, and yearly Main Quality control parameters in the IVF laboratory?
Daily Quality Control:
- Monitoring of Temperature of (incubators, hot stages, blocks), humidity and liquid nitrogen tank levels.
-Equipment calibration such as incubators, microscopes,freezers and centrifuges is necessary to ensure accurate measurements and consistent performance.
-Media quality control and availablity and expirey.
-sterilization and infection control of cleaning walls, Floors, and stages.
-Documentation and logbooks, laboratory procedures, observations, and outcomes are essential for quality control and traceability.
Monthly Quality Control:
-Biosurvival and embryo assys
-Consumable availability
-Expiration dates of consumables such as pipettes, culture dishes, and needles are important to maintain consistent results.
-Assessment of embryo development according to KPIs
-Quality control of cryopreservation procedures: Monitoring the viability and survival rates of frozen-thawed embryos and gametes helps ensure the effectiveness of cryopreservation techniques.
Yearly Quality Control:
-External quality assessment
-Review of laboratory protocols and SOPs
-Staff training and competency assessment
source of culture media contamination
source of culture media contamination:-
* air, gas supply, plastic ware, and handling malpractice
Root cause analysis
Applied after any significant problem to
identify the causes of the problem
why it happened using tools like:- (5 whys), fishbone diagram, or by Person chart….etc
this should followed by CAPA
Corrective action and preventation action
fishbone diagram and PMMMM?
Fishbone diagram identifies many possible causes for an effect or problem. It can be used to structure a brainstorming session.
P= people
M= machine
M= materials
M= Methods
M= Measurments
The 5 Whys method
The 5 Whys method is a powerful and straightforward approach to root cause analysis that has been used in various industries worldwide. It focuses on asking why a problem happened and asking four more “whys” until you find the main cause
**In case of intotroduction a new aquipment in the IVF laboratoy,
manufacturer should provide………………….
In case of intotroduction a new aquipment in the IVF laboratoy,
manufacturer should provid
1. Installation Qualification (IQ): documented proof that the equipment has been delivered and installed in accordance with the requirements and statutory safety regulations stipulated in the design qualification. IQ documentation includes a test plan
2. Operation Qualification (OQ): documented proof of a test process that evaluates whether the equipment functions correctly. All items specified in the test plan are processed and documented in writing, to ensure that the system functions in accordance with specifications. OQ documentation includes a test plan and a report.
3. Performance Qualification (PQ): Documented proof that verifies reproducible equipment function across the entire specified working range and limits.
IVF Lab Baseline comparison KPIs
KPIs
2. 1. Fertilization rates
2. Cleavage rates
3. Blactocyst formation rates
4. Implantation rates D3/D5
5. Clinicalpregnancy rates
IVF Lab Baseline QMS elements
QMS elements
2. 1. Process flowchart
2. SOPs
3. Job descriptions for all staff
4. Forms (records, procedures, instructions,….)
5. Consent Forms
6. KPIs
**IVF Lab Baseline SOPs elements
SOPs elements
2. 1. Goals of the procedures
2. personal allowe to apply the procedures
3. used equipment
4. How to perform
5. Validation for procedures
6. other related procedures
CAP
College of American Pathologists
JCT
Joint Commision International
What are the basic criteria of disposable plastics for ART?
Disposable plastics should be:
CE-marked (for Europe),
FDA approved (for the US),
MEA tested where possible and certified as endotoxin-free with validation evidence.
DNA-RNAse free pipette tips are recommended
Limulus Amoebocyte Lysate (LAL) test for …….
test for endotoxins
