Chapter 5 - Quality Management in the Hematology Laboratory

Discuss how quality policies and processes are integrated into the lab to create a quality management system (QMS)

SWOT
SOAR
RCA

Describe the role of the Centers for Medicare & Medicaid Services (CMS) in regulating lab testing

CMS regulate all lab testing (except research) performed on humans in U.S. through CLIA 1988

CLIA = Clinical Laboratory Improvement AMendments

commissions and groups under CLIA

CAP = College of American Pathologist

• accreditation for labs

NAACLS = National Accrediting Agency 4 Clinical Lab Science

JCAHO = Joint Commission on Accreditation of Healthcare Organizations

DNV

JC = Joint Commission

FDA = Food and Drug Administration

• *BB

List and describe the 7 principles of a quality management system

1. Customer focus = meeting customer requirements, striving to exceed customer expectations

2. Leadership = leaders must work together to create an environment in which people are engaged in attaining lab quality goals

3. Engagement of personnels = competent and engaged personnel throughout the organization to create and sustain the quality initiatives

4. Process approach = QMS interrelated processes work as a system enabling an effective and efficient lab

5. Improvement = creaing a system or process for ongoing awareness for continuous improvement in lab operations

6. Evidence-based = analysis and evaluation of patient and test data, identifying lab best practices, and possibly incorporating Diagnostics Mangement Teams (DMT)

   1. *SWOT, SOAR, RCA

7. Relationship management = creating and sustaining relationships with medical providers and practitioners

Discuss when and how the following quality approaches are used: Benchmarking, Lean, 6 Sigma, Root Cause Analysis (RCA), Failure Mode & Effects Analysis (FMEA), Define, Measure, Analyze, Improve, and Control (DMAIC)

Benchmarking = practice of comparing the individual lab processes and performance metrics to industry best practices from other labs.

Lean = process improvement tool to identify nonvalue-added activities considered as waste (defects, waiting, extra processing, transport, motion, inventory, overproduction). helps reduce TATs.

6 Sigma = focuses on reducing waste by reducing variation. calculation for sigma scale quality process has a score of 3-6.

RCA = examines what happened, how it happened, and why it happened.

FMEA = risk management tool used to identify possible failures of a product or service then determine occurrence rate, severity, and detectability.

DMAIC = 5-phase method for improving existing problems with unknown causes.

Explain the significance of each of the Quality System Essentials (QSE)

*OMIT

• Organization / Leadership = create an organizational

• Customer focus =

• Facilities and safety management =

• Personnel management =

• Supplier/inventory management =

• Equipment management =

• Process management =

• Documents and records management =

• Information management =

• Nonconforming event management =

• Assessments =

• Continual improvement =

*don’t need to know all of these

6 procedures (CMS) are minimal regulatory requirements for assessment of competency for all personnel performing lab testing

1. direct observations

2. monitor recording and reporting

3. review

4. direct observations

   1. instrument maintenance and function checks

5. assessment of test performance (competency testing, CMS via CLIA)

6. assessment of problem-solving skills

quality assurance vs. quality control vs. quality assessment

Q Assurance = the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled

QC = the measurement of deviation from the average that is used in the interpretation of laboratory test results as well as monitoring the laboratory performance

Q Assessment = a quality effort that is concentrated on assessing the testing process, procedures, and corrective action to prevent future problems

Discuss the specimen Path of Workflow in the prexamination (preanalytical), the examination (analytical), and the postexamination (postanalytical) stages and how quality processes are critical to quality patient results

Preanalytical = most common source of lab errors, from time health-care provider orders the test through the processing and delivery of the specimen to the lab

Analytical = errors that occur during the testing phase

Postanalytical = occur after the test results has been released

Define accuracy, precision, and error as they apply to test results

accuracy = a test result that is close to its true value

precision = refers to the reproducibility of a result

error = the difference between the true value and the obtained value

Explain standard deviation and how it is related to the distribution of results about the mean

SD measures precision, expected that a group of values will range from the smallest to the largest with most of the values clustered in the middle range (Gaussian distribution / bell curve)

mean = indicator of accuracy or systematic error

Outline the process for method validation, including the various experiments required to determine the reportable range and the reference range

Application characteristics = include volume of specimen, type of specimen, appropriate workload, operator skills, cost per test, time for analysis, and operator training

Methodology characteristics = type of standards or calibrators, reagents and reaction conditions, traceability of standard or calibrator assigned values, method principle, measurement principle, and measurement capabilities

Performance characteristics = should include working range, imprecision, interference, bias vs. the reference method, and total errors < 10%

Describe the purposes of QC matrix and assayed vs. unassayed QC as a quality control materials

QC matrix = A term describing the substance of the QC material. Regulations require that the control material be as close as possible to real human specimens. For example, urine tests should be controlled by a urine-like control material, etc.

Assayed QC = A commercially prepared assayed control has expected mean and SD values provided by the manufacturer. The laboratory will need to validate the values, usually by running a new lot of QC before an old lot has been exhausted or expired, referred to as parallel testing, before running the new lot of control material to monitor patient samples.

Unassayed QC = A commercially prepared control that does not have specific ranges verified by the manufacturer. The laboratory must run the control material in replicate over several days or weeks to establish an initial mean and SD

Discuss the importance of Delta Checks for test results integrity and patient safety

detect significant changes in sequential pt results. can indicate a critical change in pt condition or a possible misidentification, which is a major pt safety event

Describe a Gaussian distribution and how it applies to QC

68% 1SD, 96% 2SD, 99% 3SD. If values do not peak at the center, they are considered skewed

Explain a trend vs. a shift from a Levy-Jennings graph

L-J graph is a visual view of how the QC is performing, and therefore, how the method is performing

Shift = could be caused by improperly prepared reagents or controls

Trend = could be caused by deterioration, temperature fluctuation, etc.

***TEST

Discuss the Westgard MultiRules decision criteria and how they are used to determine whether a quality control run is acceptable

a series of decision criteria (control rules) to decide whether an analytical run is in-range or out-of range

1_2s = one data point exceeding the ± 2 SD limit

1_2.5s = one data point exceeding the ± 2.5 SD limit

1_3s = one data point exceeding the ± 3 SD limit

2_2s = two consecutive data points exceeding the ± 2 SD limit

R4s = one data point exceeding the ± 2 SD limit, and another close data point exceeds the -2 SD limit

2 of 3_2s = 2/3 control points exceeding either +2 SD or – 2 SD limit on same side

7T = seven consecutive data points trending in the same direction

41s = four consecutive control measurements exceeding the +1 or =1 SD limit on same side of graph

10x = 10 consecutive control measurements falling on one side of the mean

Describe when a method validation study is necessary

• Once a new method or new instrument has been chosen and is installed

• Focus is to introduce about the same amount of error that would be present daily in the normal running of the test or instrument