Chapter 12: Documentation Flashcards Preview

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Flashcards in Chapter 12: Documentation Deck (14)
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1
Q

It may be written or electronic and part of daily operations and regulatory compliance?

A

Laboratory Documentation

2
Q

What does Laboratory Documentation include?

A

Laboratory policies, Laboratory process, Laboratory procedures and records of daily activities

3
Q

Informs the laboratory staff what activities to perform, how and when to perform them

A

Documents

4
Q

Provides evidence that activities were performed

A

Records

5
Q

Required to maintain detailed documentation about the qualifications of each employee and should contain additional information which addresses the fact that healthcare workers are at risk occupational exposure

A

Personnel Files

6
Q

Must include a procedure for performing every test on your laboratory’s test menu as well as instructions for patient identification, specimen collection and handling, documentation and test reporting

A

Procedure Manual

7
Q

What are the instrument files?

A
  1. Instrument name
  2. Model number and serial number
  3. Purchase data Manufacturer and/or supplier contact information
  4. Technical service contact information
  5. Repair . service contact information
  6. Warranty information
  7. Preventive maintenance and repair services performed by company representatives
  8. Verification of performance specifications, if APPLICABLE
8
Q

It should include a place to document instrument function checks, preventive maintenance and any other requires monitoring

A

Equipment MAintenance

9
Q

It retains instrument tapes and/or printout

A

Calibration and Calibration Verification procedures

10
Q

must document all QC results, and graph quantitative results for visual evaluation of shifts and trends over time.

A

Quality Control

11
Q

Must be recorded daily and if any temperature and/or humidity reading is out of range, corrective actions must be taken and recorded in the log

A

Temperature and Humidity Logs

12
Q

Laboratory’s method for monitoring and keeping track of a given test and its components across the entire path of workflow

A

Test tracking system

13
Q

Planned, ongoing review process that observed the performance and evaluates the quality of all laboratory related activities

A

Quality Assessment

14
Q

What are Proficiency Testing?

A
  1. copy of the PT enrollment order form
  2. instructions that come with the samples
  3. all worksheets and instrument printouts of testing
  4. copy of final completed result form, including signed attestation statement
  5. reviewed PT score report including the CMS summary page
  6. Documentation of investigations and corrective actions for any PT failures