Administration and Management Flashcards
Describe Random Error
due to chance and exists in all measurements.
Describe systematic error
systematic error influences values consistently in one direction
describe active error
active error occurs at the interface between a laboratorian and the patient samples
describe latent errors
latent errors are related to the organization or design of a laboratory.
This type of error is due to chance and can exist in all measurements.
random error
This type of error influences values consistently in one direction.
systemic error
This type of error occurs at the interface between a laboratorian and the patient sample.
active error
This type of error is related to the organization or design of a laboratory.
Latent Error
Name six sources of variation (factors that affect the measurement of an analyte):
- sample error2. random analytical error3. method or instrument bias (analytical systemic error)4. operator error5. sample (day-to-day variation within a single patient)6. patient (patient variation - race, sex, age, health status)
Using Westgard Rules, when would use a run as a warning and why?
1(2S) - accept the run; use as a warning when one control results exceeds 2 SD
Define Reflex Testing.
The performance of a test on a patient specimen only after a particular analyte is abnormal or outside of a predetermined range. It includes follow-up testing automatically initiated when certain test results are observed in the laboratory; it is used to clarify or elaborate on primary test results.
Give an example using sickle cell screening of reflex testing.
A positive sickle cell screen reflexes a hemoglobin electrophoresis.
Give an example using leukocyte esterase of reflex testing.
A positive reagent strip leukocyte esterase reflexes a urine culture.
Name Four Common Types of Error.
Random Error exists in all measurements and is due to chance.
Systematic error influences values consistently in one direction.
Active error occurs at the interface between a laboratorian and the patient samples.
Latent errors are related to the organization or design of a laboratory.
What are the main responsibilities of a laboratory director?
The lab director is responsible for the overall operation and administration of the laboratory and for assuring compliance with the applicable regulations.
What happens in the case that a laboratory has more than one individual that qualifies as a director?
The laboratory is required to designate one individual who has ultimate responsibility for overall operation and administration of the laboratory.
What are the five main overall management processes used in a clinical laboratory by the director?
- planning and decision making2. organizing3. staffing4. controlling (monitoring and correcting)5. directing
Summarize the Planning and Decision Making Duties of a laboratory director.
Determining the organizations goals and deciding how to best achieve them.
Summarize the Organizing Duties of a laboratory director.
Determining how best to group activities and resources.
Summarize the Staffing Duties of a laboratory director.
Finding, placing, and keeping the right staff
Summarize the Controlling Duties of a laboratory director.
monitoring and correcting the ongoing activities to facilitate goal attainment.
Summarize the Controlling Duties of a laboratory director.
monitoring and correcting ongoing activities to facilitate goal attainment.
Summarize the Directing Duties of a laboratory director.
Telling people what to do and seeing that they do it.
Describe a forecast budget.
where budget line items, such as salaries and benefits, are increased or decreased on the basis of a previous year’s budget. This type of budget is based primarily on the number of tests performed in the laboratory. The budget for the next year is based on the revenues produced from the past year together with the expected forecast from the anticipated number of tests to be performed in the next year.
Describe an Appropriation Budget.
where a fixed amount of money is granted for a fixed period of time, usually 1-2 years. This type of budget can cause shortfalls and inappropriate spending. This type of budgeting is most often associated with government bodies.
What type of budget is most often associated with government bodies and can often cause shortfalls or inappropriate spending?
An Appropriation Budget.
Describe a Flexible Budget.
where fixed (ie. overhead) and variable expenses (ie, reagents and consumables) are itemized. This type of budgeting is useful where a certain level of activity, such as test volume, is subject to change since the variable portion of the budget can be adjusted accordingly.
What type of budgeting is useful where the level of activity, such as test volume, is subject to change?
Flexible budget
Describe an Operational Budget.
used primarily by laboratory managers for the continuous operation of an organization.
Describe a Capital Budget.
specifically designed for the purchase of equipment, expansion of a program or building, or remodeling.
Describe a zero-based budget.
historical budget information is disregarded and each budget cost and revenue item is developed new. This process involves developing a description and ranking of all activities, ongoing and proposed. The highest ranked items are funded. Can be used to eliminate ‘dead wood’.
What type of budget can be used to rank items and fund the highest ranked items, which can be useful to eliminate ‘dead wood’?
A Zero-Based Budget
Fixed Costs / Test Price - Variable Costs
cost analysis formula for Tests to Break Even
(Fixed Costs/Test Volume) + Variable Costs
cost analysis formula for Charge to Break Even
Fixed Costs / (Test Price/Unit - Variable Cost/Unit)
Minimum to Break Even
Fixed Costs / Contribution Margin %
Minimum to Break Even
(Test Price/Unit - Variable Cost/Unit) / Test Price/Unit
Contribution Margin %
Salary expenses (costs) account for approximately what percentage of the laboratory budget?
60 - 80%
What costs are associated with Salary Costs?
hourly pay or salaried wagefringe benefitscosts associated with recruitment and selectionorientationinitial training costsongoing growth developmentcontinuing education
What percentage of salary are fringe benefits?
20-25%
Prime Costs
= direct labor + direct materials
conversion costs
= direct labor + section overhead
full production costs
= direct labor + direct materials + section overhead
Ready to Serve Costs
= section overhead + collection and reporting + general laboratory overhead
Fully Loaded Costs
= prime costs + ready to serve costs
Describe financial accounting.
uses double entry bookkeeping and standard reporting forms and follows general accepted accounting principals. Looks at costs in aggregate and is useful for only external review.
Describe cost accounting.
uses less formal rules, identifies costs on a unit basis and is useful only for internal purposes. permits assignment of costs to each revenue generating activity in the detail desired.
Describe cost accounting.
uses less formal rules, identifies costs on a unit basis and is useful only for internal purposes. permits assignment of costs to each revenue generating activity in the detail desired.
This type of accounting is useful for external review.
financial accounting
This type of accounting is useful for internal purposes
cost accounting
Describe Direct Costs.
those costs directly assigned to the production of a product, and in the case of a laboratory, the product is a billable test result. Includes consumables and supplies required to perform the test, technical labor related to performing the test and QC related to the test, and apportioned and depreciation equipment costs.
Describe Indirect Costs
those costs not directly involved with the production of a billable test.
Describe some of the items included in indirect costs.
costs to acquire specimens and bill for tests,major component is personnel costs,personnel time of those not performing the tests (ie. supervisor, phlebotomists, secretaries), office supplies,billing costs,courier service
Describe Variable Costs
those costs which change with production volume
Describe Fixed Costs
those costs that do not change with production volume
Describe some of the items included in Fixed Costs
lease on equipment,building costs (rent, utilities),
technologists needed for coverage regardless of work level,
administrative overhead (client services, sales, marketing),management related supplies
Describe three items included in administrative overhead.
client services, sales, and marketing
Describe Prime Costs.
director labor and direct material costs which are necessary to produce a billable result.
Describe Conversion Costs.
those costs necessary to produce a billable result without considering cost of materials.
True or False: Under CLIA ‘88, not all laboratories are required to implement a quality assurance program to monitor and evaluate the overall quality of lab services.
False
Describe a Quality Assessment program.
Used to monitor and evaluate the overall quality of laboratory services.
What are the three main purposes for having a quality assessment program?
- assess and improve the reliability and efficiency of the laboratory.
- ensure the highest possible quality of service is provided
- comply with regulatory requirements.
True or False: A Quality Assessment Program does not have to address pre-analytical phases of laboratory operation.
False; a QA program must include all phases of laboratory operations including pre-analytical, analytical, and post-analytical.
True or False: A laboratory must have written policies and procedures dealing with their quality assurance program.
True
Name the five major goals associated with a quality assessment program.
- ensure policies and procedures are effective and comply with lab laws and regulations.2. ensure accurate, reliable, and efficient performance of tests and test reporting.3. improve overall quality4. ensure a safe environment for patients and staff.5. meet the physician’s need for rendering a diagnosis and treatment of patients
Define “Critical indicators”.
processes or events that reveal how well the laboratory is functioning
Where in CLIA ‘88 can you find information describing specific areas of the laboratory that must be monitored by critical indicators?
CLIA ‘88, Subpart M
What 8 categories should always have critical indicators?
- appropriate utilization of services2. competency of personnel3. observed or reported incidents4. proficiency testing5. quality control6. Safety7. test management and performance8. user satisfaction
What members of the laboratory should discuss the quality assurance reviews?
lab staff, lab director, and lab management
The scope of a Quality Assurance procedures should address what aspects of the plan?
Who, What, Where, When, Why and How
The HOW question addresses what portion of a Quality Assurance plan?
The method that will be used to collect the data to evaluate the critical indicator threshold or expectations.
Name some examples of methods used to address the critical indicators of a Quality Assurance plan.
chart audits, laboratory test log reviews, corrective, remedial action log reviews, QC record reviews.
Describe what elements are in a Quality Assurance plan.
Elements are the policies and procedures associated with each phase of testing.
What represents the WHAT of a QA plan?
elements (policies and procedures associated with each phase of testing) are used to determine the critical indicators.
What is the WHERE portion of a QA plan?
These are all the sites of a laboratory. These sites may include satellite clinics, draw sites, or stat laboratories.
HOW can a laboratory achieve its QA plan?
A checklist that is reviewed monthly or quarterly can be used to cover many of the critical indicators. A log book of complaints that can be reviewed. A planned audit of patient charts can also be used to identify critical indicators.
WHO should perform the Quality Assurance reviews?
The WHO will depend on the size of the laboratory.
What seven items of information should be included in the documentation of QA activities?
- Date of QA review, complaint or problem2. initials or name of the person conducting the review or investigating a complaint or problem3. scope or method of the review4. analysis of the problem5. written documentation of any corrective action taken6. a description of the effectiveness of the corrective action and date of the follow-up review7. documentation that the QA review has been discussed with the lab staff, director, and manager(s)
How long should a lab retain QA documents?
2 years
