MDL190 - Module 2 Learning Objectives

Apply standard deviation formula to data sets.

Data points within 2 standard deviations of the mean are considered within reference range/”in control”/normal, and data points outside of 2 standard deviations are considered out of range/”out of control”/abnormal. Data within 2 standard deviations represents 95% of the population.

SD= √Σ(x−µ)²/(n-1)

Define Reproducibility

the extent to which consistent results are obtained when a test is repeated

Define Situational Ethics

acts are judged within their contexts instead of by categorical principles

Define LIS

Laboratory Information System, Maintain a record of all control results, proficiency test results, instrument maintenance, and time and temperature checks, Patient specimen logs,

Define Accuracy

closeness to the actual value

Define Precision

how close results are to other results

Define Index of Precision

AKA Coefficient of variation; used to compare old and new instruments or testing methods that are used for analysis

Define Coefficient of Variation

AKA Index of Precision; used to compare methods of analysis to one another, specifically when implementing a new instrument or testing method

CV (%)= (SD/mean) x 100

Define Specificity

the ability of a test to correctly exclude individuals who do not have the given disease (false negative/false positive)

Define Sensitivity

the ability of a test to detect a given disease (positive positive/positive negative)

Define HIPAA and describe the importance of HIPAA in healthcare and to the clinical lab

Health Insurance Portability and Accountability Act (1996)

Sets privacy and safety standards for physical and electronic health information transactions. Protects the patient, and any other “covered entity” like healthcare providers, insurance companies, and billing companies. Confidential medical information should never be discussed outside of the lab. Employees need to verify identification of individuals requesting test result information

Describe lean principles of management

The purpose of lean principles is to maximize efficiency and minimize errors

Reduction of unnecessary and value-diminishing activities to reduce total production time and effort; Identify steps in the procedure that are error prone; Do activities right the first time with as little time and effort wasted

Describe the different aspects of an employee’s job that are evaluated during annual performance reviews

Professionalism evaluated annually by management

Competency training is evaluated annually

Each individual performing laboratory tests must have documented annual training to verify competency

Must have initial training, six months and annual competency assessments available for a surveyor to review

Describe the problem solving process

1. Identify the problem

2. Gather information

3. Create alternatives

4. Choose an alternative and Implement the action plan

5. Evaluate and revise the action plan if needed

Identify root cause analysis and how it relates to the lab.

Evaluation of all processes and common causes that are involved in an adverse event to determine the underlying cause

Describe the purpose of CAP, and the frequency CAP requires procedure manuals to be reviewed and refrigerators to be monitored.

Procedure manuals are reviewed every year by CAP

Refrigerators are monitored

Explain when and how LIS can be applied to the clinical lab

Accreditation organizations assess the management of information in all clinical areas

Explain the appropriate course of action when quality control is not within 2 standard deviations.

That quality control is rejected

Identify allowable limits for controls, based on acceptable ranges and standard deviations

Identify at least 4 benefits of laboratory automation

1. Links patients, specimens, testing, and information technology systems

2. Reduces medical errors, more reliable results

3. Improves safety for lab staff

4. Shorter turn around time for results

Identify different types of lab analyzers.

Identify information management activities and documentation which may be assessed by lab and hospital accreditation surveyors and the frequency with which they are assessed

Maintain a record of all control results, proficiency test results, instrument maintenance, and time and temperature checks because these are all assessed by CAP, CLIA, and Joint Commission. Records must be kept for Blood Bank up to 10 years, and Pathology for 20 years.

Instrument inspection cycles are every 2-3 years. Record of new instrument compared to old instrument must be available, as well as software updates, calibration, and quality control results.

Approval of the instrument, training, and major records

Procedure manuals reviewed by CAP every year

Personnel training records

Identify the purpose of inventory management

To assess the efficient use of supplies, reagents, services, and instruments

Organize purchases among departments, bundles the acquisition of items from one vendor

Contract with outside vendors for maintenance, blood products, and hazardous waste management

Explain what is meant by protected health information, who is authorized to view this information, and what safeguards are in place to prevent unauthorized access.

Health information is protected

your hcp can only share your info face-to-face, over the phone, or in writing. may share relevant information if: You give your provider or plan permission to share the information. You are present and do not object to sharing the information. You are not present, and the provider determines based on professional judgment that it’s in your best interest

“Access control” tools like passwords and PIN numbers, to help limit access to your information to authorized individuals. “Encrypting” your stored information. That means your health information cannot be read or understood except by those using a system that can “decrypt” it with a “key.” An “audit trail” feature, which records who accessed your information, what changes were made and when. • • • Finally, federal law requires doctors, hospitals, and other health care providers to notify you of a “breach.”

Explain the importance of a job description and when it should be available to a candidate

Must be available at the interview to ensure that the candidate is aware of job expectations, qualifications, and reporting relationships

Explain the Joint Commission National Patient Safety Goals and how it relates to the lab.

Discuss the purpose of Proficiency Testing, describe how these samples are handled in the clinical lab, and how the acceptability of results is determined.

compares results from peer labs ran on the same sample

can be performed on automated or manual tests

an external quality assessment tool for the laboratory’s methods, Instrumentation, and staff training

Describe the purpose and components of an exposure control plan.

policies put in place by the employer regarding precautions to take when working with blood and body fluids

Describe the relationship of the Hazard Communication Standard from OSHA, SDS sheets, proper disposal of chemicals, and communication with employees.

The Hazard Communication Standard, AKA the SDS (Safety Data Sheet/s) includes properties of chemicals, safe handling practices, storage, transportation, and disposal of chemicals

Discuss the purpose of standard precautions.

The purpose of Standard precautions is to reduce the spread of bloodborne pathogens by treating every specimen as if known to be infectious.

Explain the possible sources of problem if the majority of control values fall on one side of the mean

Shift; caused by a sudden systematic error that persists, such as instrument malfunction, loss of calibration, or improper reagents

Explain the possible sources of problem if the majority of control values increase or decrease

Trend; slow movement away from the mean caused by systematic errors such as reagent deterioration, control deterioration, or a lens progressively getting dirtier

Identify criteria applied to interpreting internal quality control data

Identify how a Gaussian distribution relates to standard deviations

A Gaussian curve is a line that follows the data results of a histogram, forming a bell-shaped curve. It’s used to illustrate the mean of data points and standard deviations as the data points move away from the mean (+/-)

Identify PPE commonly found in the lab, and how PPE relates to clean and contaminated areas of the lab.

Gloves, gown, face protection.

Clean areas (break rooms, lunch areas, admin): no gloves or gowns

Contaminated areas (bench tops, etc.): must wear appropriate PPE

Define assayed and unassayed controls and the advantages/disadvantage of each type

Assayed controls have a KNOWN VALUE, whereas unassayed controls have an UNKNOWN VALUE

Assayed controls are good for use before patient testing, unassayed are good for quality assessment

Explain the purpose of analytic Quality Assurance and Quality Control programs in the clinical laboratory.

Quality Assurance is an all inclusive system to monitor the accuracy of test results, assesses staff competency, resources, facilities, procedures, methods, and instruments

Quality Control specifically monitors the analytic process on a daily basis to detect and minimize errors, flagged using the Westgard rules

Describe the relationship of precision and accuracy to total error and the acceptability of a measurement.

List at least two causes each of random error and systematic error in a test method.

Random error: caused by difficulty with exact pipette delivery or specimen collection errors

Systematic error: caused by a lens progressively getting dirtier or reagent deterioration

Define Westgard rules and apply each of the rules in different scenarios.

Westgard rules are used in relevance to a Gaussian curve and are used to monitor quality control/control errors.

1-2S: 1 data point/control test exceeds ± 2 Standard deviations

1-3S: 1 data point/control test exceeds ± 3 Standard deviations

2-2S: 2 consecutive data points/control tests exceed ± 2 Standard deviations