Regulation and guidlines

Question 1

True or False: In partner Donation.

►Member states are allowed to require testing at fixed time intervals which they may determine up to a maximum of 24 months(2years) instead of at the time of each donation.

Answer 1

True

note: (each partner is considered as donation)

Question 2

For donations ot​her than by partners, blood samples must be obtained at the time of each donation.

1. Yes
2. No

Answer 2

1

Question 3

The competent authorities may exempt the inspectors from possessing a diploma, certificate or other evidence of formal qualifications in medical or biological sciences, awarded on completion of a university course or a course recognized as equivalent by the member state concerned.

Answer 3

true

Question 4

In relation to The E.U. Directive. General System-Oriented Inspections.

1. should be carried out at least once every four years of activity,
2. should be carried out immediately after a TE (center) was accredited, recognized.
3. necessary for any significant variation from the initial accreditation.
4. They are obligatory also be necessary if there is a history of deficiencies.

Answer 4

1 & 3

Question 5

Directive 2004/23/ec requires that: T.E. (Tissue Establishment) be inspected at least at 3 yearly intervals.

Answer 5

false♦

Question 6

On request the T.E. (Tissue Establishment) team must be able to all these procedures except:

1. Describe the quality management system
2. Explain the organizational structure and operating procedures
3. Lunch and Coffee-brakes for the auditors
4. Allocate a room for the inspectors to meet separately.
5. Explain each step from procurement to processing and distribution
6. Designate the people to accompany the inspection team during the inspection
7. Explain significant changes in facilities, equipment, processes and personnel since the last inspect
8. Explain how deficiencies have been resolved if this information has not already been forwarded

Answer 6

3.

Question 7

The inspectors have the right to interview selected staff to assess their knowledge and understanding of the procedures and the adequacy of the training provided.

Answer 7

Trueeeeeeeeeeeeeeeee

Question 8

When the Laboratory is Part of a TE, The Inspector Should:

1. Review SOPs
2. Control that testing is conform with national regulations transposing Directive 2006/17/EC
3. be allowed to participate actively in the testing performed in the laboratory.

Answer 8

1 & 2

Question 9

By Australian law, one of the following has to be cryopreserved for at least 6 months:

1. Sperm for artificial insemination by donor
2. Oocytes
3. Zygotes from cycles where the patient developed severe ovarian hyperstimulation
4. Ovarian tissue
5. Embryos which have been shown to have genetic anomalies by PGD

Answer 9

1.

Question 10

Mrs. B Is Recovering from OPU. She wants to have 2 embryos rather than one transferred. do you?

1. Agree and change consent
2. Agree and get her and her partner to sign consent
3. Inform her clinician and change consent with clinician’s per
4. Postpone decision until later.
5. Agree but Inform patient that consent cannot be changed after signing

Answer 10

4.
She is still recovering from OPU.
( -_- اذكرني بدعوة)

Question 11

Mention the common clinical laboratory and healthcare accreditation organizations

Answer 11

1. Joint Commission International (JCI)
2. College of American Pathologists (CAP)
3. Commission on Laboratory Accreditation of the College of American Pathologists (CAP-LAP): CAP-LAP
4. Clinical Laboratory Improvement Amendments (CLIA)
5. International Organization for Standardization (ISO)
6. National Association of Testing Authorities (NATA)
7. Accreditation Canada International (ACI)
8. American Association for Clinical Chemistry (AACC)