Chapter 12: Documentation

Question 1

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

Answer 1

Laboratory Documentation

Question 2

What does Laboratory Documentation include?

Answer 2

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

Question 3

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

Answer 3

Documents

Question 4

Provides evidence that activities were performed

Answer 4

Records

Question 5

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

Answer 5

Personnel Files

Question 6

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

Answer 6

Procedure Manual

Question 7

What are the instrument files?

Answer 7

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

Question 8

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

Answer 8

Equipment MAintenance

Question 9

It retains instrument tapes and/or printout

Answer 9

Calibration and Calibration Verification procedures

Question 10

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

Answer 10

Quality Control

Question 11

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

Answer 11

Temperature and Humidity Logs

Question 12

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

Answer 12

Test tracking system

Question 13

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

Answer 13

Quality Assessment

Question 14

What are Proficiency Testing?

Answer 14

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