QC & QA

Question 1

The air quality in the IVF laboratory should be.

1. Grade A on a background of Grade B
2. Grade C on a background of Grade B
3. Grade B on a background of Grade C
4. Grade A on a background of Grade D

Answer 1

4.

air quality in IVF lab grade A → on background D

Question 2

Embryo Culture is a Sterile Process

Answer 2

false

Question 3

Gentamycin is the common antibioticused in culture media because…………….

Answer 3

It is more stable than penicillin

Question 4

Washing Semen in culture media containing gentamicin………….

Answer 4

significantly reduces the bacterial load

Question 5

Severe Bacterial Contamination Causes Embryo Death

Answer 5

true

Question 6

which is NOT true regarding Culture Media Fungal Contamination

1. Causes embryo death
2. Does not appear to be embryo toxic at low levels
3. Can still produce viable pregnancies
4. Was the original observation that mouse embryos could grow in vitro
5. Most likely originates from the egg recovery
6. May become toxic at higher levels of contamination

Answer 6

1.

Question 7

Contamination is more common in:

1. IVF and ICSI
2. IVF but not ICSI
3. ICSI but not IVF

Answer 7

2.

Question 8

Which Is True about contamination in the IVF LAB

1. Shedding skin cells is the most likely cause of laboratory contamination
2. Airborne contamination is 10 times higher inside than outside
3. Walls and ceilings contain about 2-5 colonies per 25 cm²
4. Floors contain about 380 colonies per 25 cm²
5. Basic cleaning can reduce the contamination by 80%
6. Disinfectant can reduce contamination by up to 95%
7. HEPA filters can reduce airborne contamination

Answer 8

all correct

Question 9

Which of the following are NOT true Regarding the effects of light on IVF systems?

1. There is conclusive data confirming light is harmful to human gametes and embryos
2. There is significant information that light effects non-primate gametes and embryos
3. Light can effect oil
4. Light can effect HSA
5. Light can effect buffers

Answer 9

1., 4

Question 10

regarding CM Which optic Colors are the most harmful for embryo development

1. Red
2. Orange
3. Yellow
4. Green
5. Blue
6. Indigo
7. Ultraviolet

Answer 10

5, 6, 7

Question 11

Its evidence that light can induce the formation of ► hydrogen peroxide (H₂O₂) in media containing HEPES and Riboflavin

Answer 11

true

► Riboflavin (also known vitamin B2)

Question 12

Regarding wavelength, which is generally considered to be true

Answer 12

Higher wavelengths (600+) are good

A green filter is the best option to remove blue and infra-red wavelength

Question 13

Light has been linked to the production of reactive oxygen species by……

Answer 13

phot-oxidation of membrane lipids

Question 14

Reducing ROS can applied by:

1. Reducing exposure to high risk wavelengths
2. Be conscious that some buffers like HEPES after exposure generate photo-toxicity
3. Use solution that contain high concentrations of ROS Scavengers
4. Be aware that oil can be sensitive to photo-oxidation

Answer 14

1.3. 4

Question 15

What is the wavelength used for the embryoscope

1. 435 nm
2. 535 nm
3. 635 nm
4. 735 nm

Answer 15

3.

Question 16

The Main Source Of Toxic Light in the IVF lab mostly is:

1. Microscopes
2. Incubators
3. Ambient light

Answer 16

1

(Review Article)

Question 17

A Dangerous low level of oxygen is……..

Answer 17

17%

Question 18

The basis for most control Charts is

1. The mean of a set of data
2. The standard deviation of a set of data
3. The mean and the standard deviation of a set of data

Answer 18

3.

Question 19

To create a Control Chart you need to:

Answer 19

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

Question 20

A Control Chart and Levey Jennings Charts Differ by……….

Answer 20

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

Question 21

According Basic Statistics - which is true?

1. SD is a statistic that quantifies how close numerical values are in relation to each others.
2. A sample with a low SD has low imprecision
3. A sample with a high SD has high imprecisions

Answer 21

all true

Question 22

The main Decision Limits are:

Answer 22

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%

Question 23

How many samples will lie outside of 3SD by chance

1. 1/1000
2. 2/1000
3. 3/1000
4. 4/1000
5. 5/1000

Answer 23

3.

Question 24

The types of errors that a Levey-Jennings plot can identify include

Answer 24

Systematic errors

Random errors

Question 25

**Random Errors** 1. are any deviation away from an expected result 2. can be either a positive or a negative variation from the calculated mean 3. are only a negative deviation from the mean 4. All random errors must be acted upon 5. All random errors should be ignored

Answer 25

1 and 2

Question 26

**Random Errors above 1 SD** 1. may be expected to occur by chance 2. indicate system failure 3. indicate a wait and review response

Answer 26

1 and 3

Question 27

**Random Errors above 2 SD** 1. may be expected to occur by chance (~1/20 times or once every 20 months) 2. indicate system failure 3. indicate a wait and review response but follow the Westgard rules for action

Answer 27

1 and 3

Question 28

**Random Errors above 3 SD** 1. may be expected to occur by a very rare chance (~1/330 times or once every 30 years) 2. indicate system failure 3. indicate a wait and review response. 4. indicate an immediate response.

Answer 28

1, 2 and 4

Question 29

**Systematic Error**

Answer 29

**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

Question 30

**A Systematic Error that is a trend may occur:**

Answer 30

**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

Question 31

**A Systematic Error that is a shift may occur:**

Answer 31

**Change in reagents** **Change in lot numbers of devices and consumables** **External environment influences (eg roadworks, air conditioning)** **Change in protocol or methodology**

Question 32

**Westgard rules**

Answer 32

The **Westgard rules** were developed in 1981 by Dr **James Westgard** as a basis: **for​ evaluating an analytical (biochemistry) run in medical laboratories**

Question 33

**If Rule 1(2)S Occurs, which is true:** 1. This may be a random error 2. This may be the start of a systematic error. 3. You need to act on a rule 1(2)S infringement 4. Should be noted and wait for a future test 5. Considered a warning event

Answer 33

all true

Question 34

**On average, random errors may occur at a rate of:** 1. 1/100 2. 1/50 3. 1/25 4. 1/20 5. 1/10 6. 1/5

Answer 34

4

Question 35

**Rule 1(3)S means any 1 observation is.....**

Answer 35

**more than 3 SD from the Mean**

Question 36

1(3)S rule infringement is........

Answer 36

**an unacceptable random error** **It may be the start of a large systematic error**

Question 37

Rule **1(3)S** and rule **3(1)S** are

Answer 37

**Rules that can use a single variable**

Question 38

A R(4)S Rule applies to

Answer 38

**Two consecutive results more than 4 SD apar**_t_

Question 39

Rule 4(1)S applies to a set of results where… ## Footnote **Four consecutive results on the same side of the mean greater 1 SD**

Answer 39

true

Question 40

Rule 2(2)S applies to

Answer 40

**Two consecutive samples more than 2 SD on one side of the Mean**

Question 41

***Key Personnel*** **Staff Must Include**

Answer 41

**the counseling,** **nursing,** **scientific** **and medical Manager/Directors**

Question 42

**The Medical Director from January 2015 must be:** 1. only a recognized specialist gynecologist 2. only a physician 3. An andrologist 4. An endocrinologist 5. Either a specialist gynecologist or a physician 6. Either a specialist gynecologists or an endocrinologist

Answer 42

5

Question 43

**Where any of these personnel do not normally work on site, the clinic must be able to demonstrate at audit, regular involvement in** 1. clinical review 2. quality control review 3. staff attendance 4. financial activities 5. clinic activities

Answer 43

1 and 2

Question 44

**The Medical Director must have:** 1. has at least five years experience in that role 2. can demonstrate substantial similar experience in the governance of an ART unit 3. holds a Certificate of Reproductive Endocrinology and Infertility (CREI) 4. any of the above 5. any two of the above 6. all of the above

Answer 44

4.

Question 45

**A Scientific Director with a PhD must have....**

Answer 45

a minimum of four years of ART clinical laboratory experience two years of experience in a managerial and/or supervisory role

Question 46

**A Serious Adverse Event** 1. is any event associated with ART treatment 2. is any event associated with clinics activities 3. is any event associated with staffing activities

Answer 46

1. ## Footnote **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.

Question 47

**A Serious Adverse Event** needs to be investigated and be available for review at the next Certificate Body CB audit

Answer 47

true

Question 48

**A Serious Notifiable Adverse Event** 1. needs to be reported immediately to the RTAC 2. needs to be reported immediately to the certifying body (CB) 3. needs to be investigated and be available for review at the next CB audit

Answer 48

1 and 2 ## Footnote A Serious Notifiable Adverse Event is an event **only associated with an ART cycle** **associated with fertility investigation prior to treatment**

Question 49

**A Serious Notifiable Adverse Event may include**

Answer 49

**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**

Question 50

Auditing of policies and procedures must occur at least 1. monthly 2. bi-monthly 3. quarterly 4. biannually 5. annually 6. Biennially 7. Just before each accreditation review

Answer 50

5.

Question 51

**Traceability Includes**

Answer 51

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

Question 52

CWA means

Answer 52

**Critical work area** ## Footnote **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**

Question 53

**CPI is** **Critical Identification Points**

Answer 53

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

Question 54

Clinics Need to have Policies and Procedures on the Management of 1. Gonadotrophins used in ART 2. GnRH antagonists and agonsists 3. FSH and Clomid 4. All drugs used in IVF 5. All drugs supplied by the clinic

Answer 54

5,

Question 55

**The medication policies and procedures should include:** 1. Steps to ensure that drugs should not be used after their expiry date 2. Steps to ensure that returned drugs should not be reissued 3. Steps to ensure how returned but unopened drugs could be reissued 4. Steps to ensure that drugs are safely stored 5. Steps to ensure the safe disposal of unused drugs

Answer 55

1,2, 4 and 5

Question 56

**Policies should reflect that................**

Answer 56

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

Question 57

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)

Answer 57

b) ## Footnote note: RTAC: Reproductive Technology Accreditation Committee in AUSTERELIA

Question 58

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

Answer 58

all على اساس conducting audit ► opening the LN2 tanks

Question 59

Contamination is more common in: a. ICSI but not IVF b. IVF and ICSI c. IVF but not ICSI

Answer 59

c)

Question 60

CWA means: a. common work area b. critical work area c. contagious work area

Answer 60

b)

Question 61

Each change in a policy or procedure needs.............

Answer 61

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

Question 62

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

Answer 62

e) 601 too much

Question 63

75% alcohol used for : a) Incubator decontamination b) hands decontaminations c) surface decontamination d) equibment

Answer 63

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

Question 64

**true or false Cool Flourescent light is safe in the IVF LAB?**

Answer 64

-**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

Question 65

quality management system (QMS) is.................

Answer 65

**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.

Question 66

Quality control (QC)

Answer 66

**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.

Question 67

Quality assurance (QA)

Answer 67

**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.

Question 68

to avoid any errors or contamination in processing sperm in the Andrology lab..............

Answer 68

1. samples should be processed separately in time or space processing sperm one sample at a time or processing samples in different hoods. 2. 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.

Question 69

**Internal audits**

Answer 69

**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.

Question 70

**External Audits**

Answer 70

**External Audits** performed annually by an independent organization. -Certified auditors evaluate all aspects of the system and make recommendations for improvements.

Question 71

Key PIs (KPIs) are indicators deemed essential for evaluating...

Answer 71

**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.

Question 72

**Vienna consensus identified three different types of indicators:**

Answer 72

**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)

Question 73

Reference Indicator (RIs) for identifying performance of the ART laboratory.

Answer 73

-Proportion of oocytes recovered (stimulated cycles) no. oocytes retrieved/no. follicles on day of trigger*100 .........=**80-95%** of measured follicles -Proportion of MII oocytes at ICSI. no. MII oocytes at ICSI/no. COCs retrieved*100........=**75-90%**

Question 74

True or false Vienna consensus identified 5 performance indicators.

Answer 74

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%)

Question 75

what are daily, monthly, and yearly Main Quality control parameters in the IVF laboratory?

Answer 75

**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

Question 76

source of culture media contamination

Answer 76

**source of culture media contamination:-** * air, gas supply, plastic ware, and handling malpractice

Question 77

Root cause analysis

Answer 77

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

Question 78

fishbone diagram and PMMMM?

Answer 78

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

Question 79

The 5 Whys method

Answer 79

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

Question 80

**In case of intotroduction a new aquipment in the IVF laboratoy, manufacturer should provide......................

Answer 80

**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.

Question 81

IVF Lab Baseline comparison KPIs

Answer 81

**KPIs** 2. 1. Fertilization rates 2. Cleavage rates 3. Blactocyst formation rates 4. Implantation rates D3/D5 5. Clinicalpregnancy rates

Question 82

IVF Lab Baseline QMS elements

Answer 82

**QMS elements** 2. 1. Process flowchart 2. SOPs 3. Job descriptions for all staff 4. Forms (records, procedures, instructions,....) 5. Consent Forms 6. KPIs

Question 83

**IVF Lab Baseline SOPs elements

Answer 83

**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

Question 83

CAP

Answer 83

College of American Pathologists

Question 84

JCT

Answer 84

Joint Commision International

Question 85

What are the basic criteria of disposable plastics for ART?

Answer 85

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

Question 86

Limulus Amoebocyte Lysate (LAL) test for .......

Answer 86

test for endotoxins