1. Quality Management System and Quality Control
Shaimah Al-Failakawi

2. Quality Management Systems
QMS is a framework to identify, fix, and prevent recurrence of issues in all phases of laboratory operations.
QMS covers ALL phases of the laboratory’s operations:
Pre-analytical
Analytical
Post Analytical

3. Quality Management Systems
QMS includes:
The performance and monitoring of general quality control (QC)
Specimen handling
Test reporting
Internal performance assessment
Test methodologies and specifications
External proficiency testing.
Reagents
Personnel requirements
Controls and media
Safety
Equipment
Document management, and other administrative practices

4. Importance of QMS
In order to provide and maintain consistent quality testing, labs must have a system in place that-
Identifies errors that have occurred and their causes
Provides an effective process to resolve errors when they occur
Most importantly, has a process in place that provides on-going surveillance of all lab areas to identify potential sources of error before an error can occur

5. Lab Areas Covered By The QMS Plan
Pre-Analytical Testing Phase
Phlebotomy
Specimen integrity (what is that? Hint: bad sample in, bad result out…)
Analytical Testing Phase
Post-Analytical Testing Phase
Result reporting
Panic values
General lab systems

6. QMS Elements Pre-Analytical Phase
Test request
Info on req. complete with birthday, diagnosis(?), physician contact info, etc.
Specimen submission, handling, referral
Written P&P for all aspects (fasting, timed draws…)
Pre-analytic systems quality assessment
Written QA P&P
Records of QA’s you have done
Keep records at least 2 years
Personnel training
Phlebotomist (license, initial training, competency)
Specimen accessioning personnel (initial training, competency)
Patient preparation
Fasting?
Specimen collection, labeling, Preservation and transportation
Proper anticoagulant, rock the tube
Spin at right time, separate serum / plasma at right time
Packed so blood doesn’t leak during shipment (PH hazard!)
Policy and procedure manual for all of the above!

7. QMS Elements: Analytical Phase
Procedure manuals
Test systems, equipment, instruments, reagents, materials and supplies
Instrument qualification & validation
Reagent tracking, validation and qualification (What do we mean…?)
Establishment and verification of performance specifications
Can’t assume instruments work properly: scientists must prove it!
Instrument maintenance and function checks
Calibration and calibration verification (what is calibration verification?)
Quality control procedures (internal & external QC)
Written QA P&P for all of the above
Records of QA’s you have done
Keep records at least 2 years
Policy and procedure manual
Forms for implementation
Each employee trained and documented
Instrument maintenance, calibration
Quality control (QC)
Internal QC
External QC ≡ Proficiency Testing (PT) and corrective action

8. QMS Elements Post-Analytical Phase
Test reports
Valid reference ranges
Results correctly transcribed from instrument to final report
Signed or released by appropriate CLS
Amended reports properly marked
Test report completeness
Panic value procedure and follow up
Turn–around time evaluation
Test menu and methods
Policy and procedure manual
Storage and retrieval of result

9. QMS Elements General Lab Systems
Facilities
Confidentiality of Patient Information
Proficiency Testing (external quality control)
Complaint Investigations
Communications
Personnel Competency Assessments
Records Retention
Safety

10. Troubleshooting Analytical Methods
Pre-analytical
Phlebotomist/Samples
Identification of the patient
Mislabeled tube
Incorrect tube
Incorrect sample (fasting?)
Information on the tube
Insufficient sample
Hemolyzed sample
Clotted sample
Sample not on ice
Pre-analytical
Contamination of blood
Sample not protected from light
Proper sample transportation
Storage problem
Centrifuge problem
Expired tube
Adding blood from one tube to another (second tube did not have enough blood
Venous blood vs Arterial blood

11. Troubleshooting Analytical Methods
Sample problem
Hemolyzed, QNS…
Instrument problem
Maintenance, service,…
QC problem
Reagent, controls, calibrator, …
Testing personnel
Trainee, personal problem, communication,…

12. Troubleshooting Analytical Methods
Post-analytical
Wrong report was issued
Critical values not informed
Hemolyzed, lipemic,… report was sent without comment
Patient’s info on the report was not correct
Age
Gender
Name of the physician
Name of the lab (if send out)
Test method
Interpretation of the test (if applicable)
Normal ranges on the report does not match with the lab’s values

13. Pre-analytical Questions
Practice/Examples
Pre-analytical Questions
If you drew for 2 patients and forgot to label them and the patients left, what do you do?
How often are the refrigerator’s/freezer’s temperatures recorded?
If you receive a hemolyzed sample, do you run the sample? What tests may be affected by hemolysis? How do you deal with the tests that have been effected?

14. Practice/Examples
A physician calls you and asks about an abnormal high Glucose for one of his patients which does not correspond to the patient’s history. You check the results and samples and notice the laboratory mixed up the patient with another and sent the wrong report. What do you do?

15. What is Quality Control?
Designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory.
Quality control is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions.
Quality control is a check to make sure the entire test system is functioning as expected

16. Why Do We Run Controls? We Use Them To Monitor:
Calibration Curve (“deteriorating” curve)
Reagents (“deteriorating” reagents)
Instruments (“deteriorating” components)
Environment (defined by the manufacturer)
CLS (pipette technique, etc…)
What else???

17. What is the Difference Between Controls and Standards (Calibrators)?
Used to calibrate a test system
Manufacturers work very hard to make them extremely accurate
Expensive
Controls
Used to check calibration of a test system
Manufacturers make pools of serum or plasma
Assay & add analytes to get “normal” and abnormal controls
Less expensive than standards
Can you use old proficiency materials as a control if you’re having problems?
Can you run a patient as a “control”?

18. Quality Control and Proficiency Testing
QC: Internal verification of accurate and reliable results
The only way you know that your systems are working at the moment you are doing testing
PT: External verification of accurate and reliable results
Laboratories getting the same results on the same samples verifies that the labs are producing accurate and precise results

19. Should Vs. Must When Should QC Be Run?
Prior to reporting patient results
Based upon manufacturers’ requirements
Your own lab’s policies & experience
Does anyone run tests w/o QC on the day of testing?
When MUST QC Be Run?
at the beginning of each shift or “day of use”
after an instrument is serviced
when reagent lots are changed
after calibration
whenever patient results seem inappropriate

20. What are Qualitative Controls? What are Semi-Quantitative Controls?
Types of Controls
What are Qualitative Controls?
“Positive or Negative” test systems
Is a negative control and positive control enough?
Urine glucose confirmation (simple cutoff)
Hep. B test (complex cutoff)
Negative control
Low “positive cutoff” value control (detects loss of sensitivity. At least run this level…)
“Normal” positive? (This is all some people run…)
What are Semi-Quantitative Controls?
“Graded” reactions 1+/4+, blood bank, Bacti, etc.
Examples
Urine glucose
Blood banking
Others?
Issues
Pro-zone (immunoassays)
Reagent deterioration

21. What Are Quantitative Controls?
Types of Controls
What Are Quantitative Controls?
They Monitor
Reagents (stability, calibration, etc.)
Instrument “systems” and electronics
Monitors CLS’ performance
Numerical instrument response to a known concentration
Numerical instrument response to an unknown concentration (in patient)

22. Quick Math Mean – Average
Standard Deviation (SD)-How much the members of a group differ from the mean value
Coefficient Variation (CV) - It is the ratio of the standard deviation to the mean (average)
Mean = Sum of all numbers / #of Numbers
SD=
1. Work out the Mean (the simple average of the numbers)
2. Then for each number: subtract the Mean and square the result
3. Then work out the mean of those squared differences.
4. Take the square root of that and we are done!
CV=  Standard Deviation x100                    Average

23. Standard Deviation and CV
The number of flowers on each bush is 9, 2, 5, 4, 12, 7, 8, 11, 9, 3, 7, 4, 12, 5, 4, 10, 9, 6, 9, 4
1-The mean is:
= 140/20 = 7
2- Subtract each number by the mean and square them
(9 - 7)2 = (2)2 = 4
(2 - 7)2 = (-5)2 = 25
(5 - 7)2 = (-2)2 = 4
.. etc ... And we get these results: 4, 25, 4, 9, 25, 0, 1, 16, 4, 16, 0, 9, 25, 4, 9, 9, 4, 1, 4, 9
3- Find the mean of the new numbers
= = 178/20 =8.9
4-Square Root of the New Mean:
σ = √(8.9) = 2.983
CV= 2.983/8.9 *100 = 33.56%

24. Levey-Jennings Chart
Gives a visual indication whether a laboratory test is working well.
The distance from the mean is measured in standard deviations (SD).
A mark is made indicating how far off the actual result was from the mean (which is the expected value for the control).
Lines run across the graph at the mean, as well as one, two and sometimes three standard deviations either side of the mean. This makes it easy to see how far from the mean the result was.

25. Westgard Rules
The Westgard multirule QC procedure uses different control rules to judge the acceptability of an analytical run

26. 12s
12s refers to the control rule that is commonly used with a Levey-Jennings chart when the control limits are set as the mean plus/minus 2s. In the original Westgard multirule QC procedure, this rule is used as a warning rule to trigger careful inspection of the control data by the following rejection rules.

27. 13s
13s refers to a control rule that is commonly used with a Levey-Jennings chart when the control limits are set as the mean plus 3s and the mean minus 3s. A run is rejected when a single control measurement exceeds the mean plus 3s or the mean minus 3s control limit.

28. 22s
22s  reject when 2 consecutive control measurements exceed the same mean plus 2s or the same mean minus 2s control limit.

29. R4s
R4s reject when 1 control measurement in a group exceeds the mean plus 2s and another exceeds the mean minus 2s. This rule should only be interpreted within-run, not between-run.

30. 41s
41s - warning when 4 consecutive control measurements exceed the same mean plus 1s or the same mean minus 1s control limit.

31. 10x
10x warning when 10 consecutive control measurements fall on one side of the mean. OR 5 consecutive control measurements fall on one side of the mean for two control levels.

32. The Westgard Rules

33. Question- What Rule is This?

34. “Troubleshooting is a State of Mind”
Stay calm when you have a failure:
Take a deep breath!
There’s a reason for the problem – you just need to figure it out
Getting tense doesn’t help!
Labs are high-stress, don’t let it rattle you!
“Stay strong and carry on!”
Have back-up instrumentation

35. Three Golden Rules First Golden Rule
Eliminate test system variables through exacting Preventive Maintenance and Daily QC review
Prevents 80% of problems from developing!
Second Golden Rule
When you begin troubleshooting, the first step is to review relevant preventive maintenance and quality control records
Third Golden Rule
Keep exacting reagent logs, and refer to them when troubleshooting
Prevents 80% of problems from developing

36. Ask Yourself…What Changed?
By keeping clear and detailed records, you can see (or get a sense for) what changed!
QC changes
Shifts in Levy-Jennings
Trends in Levy-Jennings
New lot of control material? (Wrong statistics)
Wrong lot of control material? (grabbed the wrong vial)
Control material made up wrong?
Instrument Changes
Component failure? (Something broken or worn out)
PM performed per manufacturer’s requirements?
Was PM performed properly???
Common problem
Something too loose or too tight?
Out of alignment?
Need for more training?
Something broke!
Something wore out!

37. Ask Yourself…What Changed?
Reagent Changes
Look for:
New reagent or outdated reagent?
New Calibration
Old calibration
New controls?
New instrument component? (lamp, ISE, pump, tubing, etc.)
Something you didn’t expect –
Water system issues
Electrical issues
Temperature issues
Humidity issues
What issues might arise in the Middle East?

38. Proficiency Testing (PT)
What is PT?
PT determines the performance of individual laboratories for specific tests
PT is a tool to monitor laboratories’ quality of performance
PT is an inter-laboratory comparison
It is a way to verify that all aspects of the laboratory measurement system is working

39. External Quality Control
External QC under ISO ≡ Proficiency Testing (PT)
Lab may enroll in a proficiency testing program such as:
CAP
AABB
The lab must assess the effectiveness of corrective action taken to address any unacceptable, unsatisfactory, or unsuccessful PT results
You must have a written P&P for this, including acceptability criteria
You must document when you do this and keep records for inspectors

40. The Role of (PT) in Laboratory Quality
PT or external quality control is the testing of unknown samples sent to a laboratory by an approved PT programs such as CAP
Most sets of PT samples are sent to participating laboratories three times per year
After testing the PT samples in the same manner as its patient specimens, the laboratory reports its sample results back to their PT program
PT program grades the results and sends the laboratory scores showing how accurately the lab performed the testing
Accreditation organizations routinely monitor their laboratories’ performance.

41. Why is PT Important?
PT is important because it is a tool for the laboratory to verify the accuracy and reliability of its testing
Routine reviews of PT results reports will alert the lab to areas of testing that are not performing as expected
It also indicate shifts and trends that, over time, would affect their patient results

42. Other Issues
If the lab have 2 or more sites, they need to be enrolled in PT for each site.
They cannot share their PT samples, results
If the lab have 2 or more instrument for testing, they can use only instrument on their PT (the one that was used that day)
Document and keep all records of PT

43. Write Down All the Errors you See

44. Laboratory Unified Handover Form