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Blood Bank > Retention of other records > Flashcards

Retention of other records Flashcards

1
Q

Management review of effectiveness of the quality system

A

5 years

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2
Q

Exception to policies, processes, and procedures

A

10 years

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3
Q

Emergency operation plan tested at defined intervals

A

2 years

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4
Q

Job descriptions

A

5 years

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5
Q

Qualification of personnel performing critical tasks

A

5 years

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6
Q

Training records of personnel

A

5 years

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7
Q

Evaluation of competence of personnel

A

5 years

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8
Q

Personnel records of each employee

A

5 years

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9
Q

Records of names, signatures, initials or ID codes and inclusive dates of employment for personnel who perform or review critical tasks

A

10 years

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10
Q

Equipment qualification

A

10 years after retirement of the equipment

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11
Q

Unique ID of equipment

A

5 years

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12
Q

Monitoring and maintenance of equipment

A

10 years after the retirement of equipment

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13
Q

Temperature monitoring of refrigerators, freezers, and incubators

A

10 years

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14
Q

Monitoring of liquid nitrogen levels or temp

A

10 years

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15
Q

Implementation and modification of software, hardware, or databases

A

2 years after the retirement of the system

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16
Q

Validation of system software, hardware, databases, user-defined tables, electronic data transfer, and/or electronic data report
Fulfillment of applicable life-cycle requirements
Numerical designation of system versions, if applicable, with inclusive dates of use
Monitoring of data integrity for critical data elements

A

2 years after the retirement of the system

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17
Q

Evaluation and participation in selection of suppliers

A

5 years

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18
Q

Agreements

A

5 years

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19
Q

Agreement review

A

5 years

20
Q

Agreements concerning activities involving more than one facility

A

5 years

21
Q

Inspection of incoming critical materials and containers

A

10 years

22
Q

Incoming containers, solutions, and reagents meet FDA criteria

A

10 years

23
Q

Validation of new or changed processes and procedures

A

5 years

24
Q

Participation in PT program

A

5 years

25
Q

QC records and review of QC results for reagents, equipment and methods

A

10 years

26
Q

Records of storage temps and blood products

A

10 years

27
Q

Ambient temperature recorded every 4 hours

A

10 years

28
Q

Inspection before shipping

A

10 years

29
Q

Container qualification and process validation records

A

10 years

30
Q

Participation in development of policies, processes, and procedures regarding recipient consent for transfusion

A

5 years

31
Q

Review and approval of new and revised documents before use

A

5 years

32
Q

Biennial review of policies, process, and procedures

A

5 years

33
Q

Identification and appropriate archival of obsolete documents

A

5 years

34
Q

Description an devaluation of nonconforming blood, components, its, derivatives, critical material, and services

A

10 years

35
Q

Nature of nonconformances discovered after release and subsequent actions taken, including acceptance for use

A

10 years

36
Q

Disposition of nonconforming products

A

10 years

37
Q

Fatality reports

A

10 years

38
Q

Transfusion service evaluation and reporting of transmissible diseases

A

10 years

39
Q

Review of assessment results

A

5 years

40
Q

Peer-review assessment of blood utilization

A

5 years

41
Q

Implementation of changes to policies , processes, and procedures resulting from corrective and preventive action

A

5 years

42
Q

Corrective action

A

5 years

43
Q

Preventive action

A

5 years

44
Q

Monitoring of biological, chemical and radiation safety

A

5 years

45
Q

Appropriate discard of blood and components

A

10 years

Blood Bank (14 decks)

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