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Transfusion Medicine Fellowship > Regulatory Aspects > Flashcards

Regulatory Aspects Flashcards

1
Q

The FDA and CMS are part of what Department of the United States Government?

A

Health and Human Services

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2
Q

What is regulated by the CFR, part 640?

A

Blood and blood components

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3
Q

What is regulated by the CFR, part 606?

A

Current Good Manufacturing Practices

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4
Q

What is regulated by the CFR, parts 1270 and 1271?

A

Human cells and tissues

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5
Q

What regulates the manufacture and production of human progenitor cells?

A

Public Health Services act, sections 351 and 361.

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6
Q

Production of a biologic product for interstate commerce requires what form of licensure?

A

Licensure with FDA; requires submission of SOPs and all records. Products are licensed within a narrow range and deviations must be reported to the FDA.

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7
Q

How are cGMP standards held up by inspection?

A

Inspection is performed by the FDA. Inspections may be level I (comprehensive) or II (streamlined). Deficiencies are disclosed on an FDA form 483.

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8
Q

What is a biologic product deviation, and how should it be handled?

A

Any deviation of a product from an event. Must be submitted to FDA within 45d as a form 3486. If a fatality results, this also must be reported within 24hrs (and 7d completely) to the FDA/CBER.

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9
Q

What part of the code of federal regulations pertains to medical devices?

A

CFR part 807.

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10
Q

How does CMS regulate laboratory testing?

A

Via CLIA (42 CFR part 493). This entails biennial inspection usually by deemed organizations.

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11
Q

What types of test complexity are delineated by CLIA regulations?

A

Waived, moderate, and complex.

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12
Q

AABB

A

Publishes voluntary compliance criteria and 2yr accreditation with inspections.

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13
Q

ICCBBA

A

The organization behind ISBT-128, the labeling symbology standard mandated by the AABB.

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14
Q

Joint Commission

A

A healthcare organization-wide accreditation group that is deemed by CMS. Covers all aspects of patient care as well as some lab (POC) testing.

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15
Q

ASFA

A

Educational member group that does not provide any inspections or accreditations but does publish respected guidelines.

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16
Q

ASCP

A

Has board of registry that previously accredited apheresis techs (AT) and hemapheresis practitioners (HP). Both titles were retired in 2008.

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17
Q

CAP

A

A CLIA deemed organization that provides q2yr lab inspections and proficiency testing.

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18
Q

FACT

A

Accrediting organization covering all aspects of cellular therapy. 3yr period.

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19
Q

World Apheresis Association (WAA)

A

An international academic organization with a biennial congress. Has no real teeth in the US.

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20
Q

What are the 8 systems of quality assurance as identified by the FDA with respect to blood banking?

A 
Quality assurance
Donor suitability
Blood collection
Manufacturing
Product testing
Product storage & distribution
Lot release
Computer systems
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21
Q

FACT-JACIE

A

Accreditation standards for all things cellular therapies. A VOLUNTARY standard, but practically required for any billing purposes.

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22
Q

What are facility agreements?

A

Definitions of the relationship between facility and customer. Should allow for collection of feedback, info about breaches, and details about orders including transport etc.

23
Q

What is the difference between a qualification and a validation?

A

Qualifications are more minor; simply verifying the function of usually a component within its normal limits. Validations cover entire processes including risk assessments, procedures, acceptance criteria, and documentation.

24
Q

How should internal audits be conducted?

A

In as close to a manner as external audits as possible. Internal auditors should have the ability to shut down processes if deemed necessary for safety.

25
Q

How is quality of a supplier maintained?

A

Evaluate agreement, ensure supplier is held to local standards and inspect their products.

26
Q

How is the quality of documentation maintained?

A

Maintain version control on documents, retention times, error corrections, and annual reviews.

27
Q

What is required of a medical director, per FDA, AABB, and CGMP requirements?

A

The medical director must be a physician. They must ensure compliance with federal regulations, be familiar with all policies, and have knowledge of immunology, patient management, safety, and teaching.

28
Q

What is regulated by 21 CFR, part 820?

A

Medical devices, including computers

29
Q

What is the difference between calibration and validation?

A

Calibration adjust an instrument’s performance to be in line with reference standards. Validation demonstrates the efficacy of the instrument in a certain setting.

30
Q

What should happen if a test or reagent fails QC?

A

The test or reagent should be offlined until the cause is identified and fixed.

31
Q

What biosafety level applies to most blood bank testing?

A

Most is done in a BSL-2 setting, some BSL-3.

32
Q

What are the different classes of biosafety cabinets (BSC)?

A

Class I: Unfiltered room air
Class II: Laminar air flow, often with exhaust to outside (group B).
Class III: Airtight, gloved access only, negative pressure. For use in BSL-4 settings.

33
Q

How often should workstation decontamination occur?

A

At least daily, with tuberculocidal or dilute bleach wipes.

34
Q

How should hazardous spills be handled?

A

Evacuate people at risk, contain the spill, use absorbent material and disinfectants. If nuclear or other hazard, facility should have escalatory containment measures.

35
Q

How long should equipment be autoclaved for?

A

1 hour to decontaminate, longer to sterilize (depends on mass of equipment to be autoclaved)

36
Q

What is a REM?

A

REM = rad (0.01Gy) times QF (quality factor, indicates damage level; alpha>beta>gamma).

37
Q

What are acceptable radiation dose limits for most workers?

A

5 rem/yr (up to 50 tolerable to extremities; limit to 0.5 if pregnant).

38
Q

What act mandates the registration of blood processors/manufacturers, deeming blood as a drug?

A

Food, Drug, and Cosmetic act (21 USC 301-399d)

39
Q

What does REGISTRATION of a blood center entail?

A

Must register facilities and list all relevant products, within 5 days of commencing operations.

40
Q

Who is exempt from having to register as a blood center?

A

Transfusion centers that perform minimal modifications (pooling, leukoreduction, and preparing WB from pRBC).

41
Q

Biologics License Application

A

Application for approval any biologic product. An approved product cannot be modified without FDA approval and requires a notification of major or moderate changes.

42
Q

What are medical device classes?

A

Class I: Lowest risk, general controls OK to prove use
Class II: More specialized, clear through 510k pathway
Class III: Equisitely complex, no standard comparison

43
Q

Form 3500A

A

Form to report adverse outcomes involving a medical device; to be submitted by manufacturer.

44
Q

What are the types of FDA inspections?

A

Routine
For-cause (eg, site opening)
Pre-approval (eg, BLA)

Level I (thorough) and level II (streamlined, eligible after 2 clean level I inspections)

45
Q

EIR, Form 483

A

EIR: Establishment inspection report; summary document from FDA inspection.

Form 483: List of deficiencies/faults

46
Q

What is the maximum interval of time permitted to submit a BPD report?

A

45 days

47
Q

What testing does CLIA oversee? How can certification be obtained?

A

Non-waived testing (moderate/high complexity). Certification can be obtained by state health department inspection or CMS-deemed inspection. Note that NY and WA are CMS-exempt (higher).

48
Q

What criteria must be met for an HCT/P to be qualified under PHS act 361?

A

Be minimally manipulated
Be for homologous use
Not be mixed or combined with non-361 products.

49
Q

Do 361 manufacturers have to register?

A

Yes, and they are subject to cGTP requirements.

50
Q

What are examples of hemovigilance programs?

A

UK - SHOT
Japan - First hemovigilance program ever
EU - EHN&raquo_space; IHN, ISARE database
US - NHSN hemovigilance module

51
Q

How is hemovigilance maintained in the United states?

A

NHSN hemovigilance module established in 2008
Mandatory FDA reporting of fatalities
Joint commission sentinel event reporting system
AABB task force
State mandated reporting

52
Q

How is donor hemovigilance maintained?

A

Not actually federally required. AABB has a donor hemovigilance working group as of 2006, and AABB-ISBT developed donor rxn codes/definitions in 2014.

53
Q

What are the 4 elements of negligence?

A

Duty
Breach
Causation
Harm

54
Q

What is strict liability, and does it apply to blood?

A

If a product is unsafe for use in its intended setting, the manufacturers can be found liable for damages even if they were not negligent in manufacturing process. This does not apply to blood, which is an “unavoidable unsafe”.

Transfusion Medicine Fellowship (34 decks)

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