Module 1

Question 1

purpose of clinical lab

Answer 1

provide high quality patient test results to clinician to aid in diagnosis, treatment and prevention of disease

Question 2

Quality definition

Answer 2

needing needs and expectations of users and customers

Question 3

Quality lab results are

Answer 3

valid
applicable
timely
cost efficient
cause no patient harm

Question 4

path of workflow

Answer 4

pre analytical
Analytical
Post analytical

Question 5

Pre analytical (4)

Answer 5

test ordering, spec collection, spec transport, spec receipt and processing

Question 6

Analytical (3)

Answer 6

test performance, review of results, interpretation of test results

Question 7

Post analytical (2)

Answer 7

Test result reporting

Specimens management

Question 8

Quality requirements: test ordering

Answer 8

legible requisition

correct pt info
applicable clinical data
appropriate test
type of specimens, anatomical region if necessary
Correct destination for test results

Question 9

Quality requirements: Specimen collection

Answer 9

patient prep
correct pt id
correct specimens collection technique
Correct tube or collection container
Adequate sample volume
Collected at right time
Specimen properly labeled

Question 10

Quality requirements: Specimen transport

Answer 10

transported in required timeframe
acceptable temp
transported safely

Question 11

Quality requirements: Specimen receipt and processing

Answer 11

verification of correctness and completeness of req and specimen label
Correctly accessioned into information system
Appropriate expedition of urgent/stat/timed specimens

Question 12

Quality requirements: test performance

Answer 12

computer system validation
equipment is maintained properly
test is performed according to procedure
defined method/test specificity and sensitivity
QC prepared correctly
Test calibration performed correctly
Correct tests run on correct specimens
Adequate specimen volume
QC monitored and acted on properly
Processes in place for recognizing presence of interfering substances
established troubleshooting processes

Question 13

Quality requirements: review of test results

Answer 13

results compared to patients previous results (delta check)
Follow up is performed when results are significantly different
Auto verification processes are validated prior to use

Question 14

Quality requirements: Interpretation of test results

Answer 14

available comparisons for interpreting data (reference range, age specific info, alert values)
Process in place to ensure test results correlate with patients diagnosis/symptoms

Question 15

Quality requirements: test result reporting

Answer 15

lab report is legible, interpretive, no mistakes
Includes pt, test and ordering info
Includes test results with reference ranges
Process in place to ensure all test results are made available at the location they will be accessed
Process for notifying clinician of alert or critical test result; documentation of notifications
Process in place for correcting reports
Method to archive and access previous test results

Question 16

Quality requirements: Specimen management

Answer 16

storage conditions to maintain stability
Specimen retention
Process in place to easily access stored specimens when required

Question 17

Stages of quality (bottom to top)

Answer 17

Q control: everyday steps and procedures

Q assurance: monitors QC data and looks for opportunities to improve processes; includes plans, policies and procedures across the entire path of specimen workflow

Q system: maintain and improve lab processes to meet quality goals

Q Management: Finances

Total quality management: Overall management of quality process and outcomes with the goal of long-term customer satisfaction

Question 18

QA program includes

Answer 18

commitment
facilities and resources
technical competencies
technical procedures
Problem solving mechanisms