Quality Management System and Quality Control Shaimah Al-Failakawi

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

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

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

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

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!

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

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

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

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

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

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

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?

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?

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

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???

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”?

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

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

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

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)

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

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: 9+2+5+4+12+7+8+11+9+3+7+4+12+5+4+10+9+6+9+420= 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 = 4+25+4+9+25+0+1+16+4+16+0+9+25+4+9+9+4+1+4+9 = 178/20 =8.9 4-Square Root of the New Mean: σ = √(8.9) = 2.983 CV= 2.983/8.9 *100 = 33.56%

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.

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

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.

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.

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

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.

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

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.

The Westgard Rules

Question- What Rule is This?

“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

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

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!

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?

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

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

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.

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

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

Write Down All the Errors you See

Laboratory Unified Handover Form