Question 1

The general organizational structure of a clinical laboratory:

Accepted Answer

A typical organizational structure in a hospital is for a vice-president to have several reporting departments.The actual organization within the laboratory should be structured to provide the greatest efficiency and is likely not made up of departments, sections, or units that correspond to the specialties and subspecialties delineated in the final CLIA '88 regulations.

Question 2

CLIA '88 defines a ______ supervisor as the immediate bench supervisor who reviews daily work and quality control and a ______ supervisor as one who acts as the principle laboratory supervisor.______ are required for high-complexity testing.

Accepted Answer

If high-complexity testing is performed, the laboratory must have a designated technical supervisor and general supervisor in addition to a clinical consultant and laboratory director. CLIA '88 defines a general supervisor as one who acts as the immediate bench supervisor and reviews work and quality control, and a technical supervisor as one who acts as the principle laboratory supervisor.

Question 3

A quality-assurance program is designed to:
1)monitor and evaluate the ongoing quality of the total testing process
2)identify and correct problems
3)ensure accurate, reliable, and prompt reporting of results
4)ensure adequacy and competency of the staff

Accepted Answer

A quality-assurance (QA) program is designed to (1) monitor and evaluate ongoing and overall quality of the total testing process and effectiveness of its policies and procedures; (2) identify and correct problems; (3) ensure accurate, reliable, and prompt reporting of test results; and (4) ensure the adequacy and competency of the staff.

Question 4

What is the most important management skill/ability that should be utilized by a laboratory director when planning changes in laboratory services?

Accepted Answer

Frequent communication with the hospital staff will keep everyone aware of the laboratory and changes in the field of clinical laboratory sciences that may lead to changes in laboratory services.Understanding the need for change increases the chance that change will be well received.

Question 5

What is the purpose of a pro forma analysis?

Accepted Answer

Laboratories are required to justify capital expenditures for one-time purchases costing over a designated amount.The formal financial justification for such capital expenditures is called a pro forma analysis.Refer to Box 19-4.

Question 6

________ regulations serve to ensure the quality of laboratory test results by defining performance standards for all aspects of laboratory testing.

Accepted Answer

The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) require that all clinical laboratories be certified for each procedure that is performed.The goal of these regulations is to ensure the quality of laboratory test results, regardless of where tests are performed.

Question 7

A laboratory test is considered a ____________ test until the test is classified by the FDA.

Accepted Answer

The FDA classifies each laboratory test with input from the CDC.Until a laboratory test is classified, it is considered a high-complexity test.

Question 8

A full-time equivalent (FTE) works how many hours per year?

Accepted Answer

An FTE works 40 hours per week for 52 weeks per year, which equals 2080 hours per year.

Question 9

Following first-year evaluations of individuals performing moderate- and high-complexity testing, under CLIA '88 regulations, how often must reevaluation be performed, given that there are no procedural or instrumentation changes?

Accepted Answer

CLIA '88 regulations require that semiannual evaluation be performed on individuals responsible for moderate- and high-complexity testing during the first year the individual tests patient specimens.Thereafter, reevaluation must be performed at least annually, provided there are no procedural or instrumentation changes.

Question 10

________ regulations serve to ensure the operation of a safe laboratory.

Accepted Answer

Occupational Safety and Health Administration (OSHA) regulations ensure the operation of a safe laboratory environment.OSHA covers all forms of laboratory safety, such as chemicals, bloodborne pathogens, and sharps injuries.

Question 11

Laboratory procedures are billed to insurance companies or organizations according to which system of coding?

Accepted Answer

CPT codes are assigned to all medical procedures, which are grouped according to common disease characteristics.Insurance companies or organizations agree to reimburse the laboratory a set amount per test.

Question 12

Which of the following usually accounts for the majority of a laboratory's annual budget?

Accepted Answer

For most laboratories, labor and supplies usually account for 70% to 75% of the annual budget.

Question 13

If tests performed by a clinical laboratory are classified as moderately complex, and no highly complex tests are being performed, the following personnel are required by CLIA '88:
1)laboratory director
2)technical consultant
3)clinical consultant
4)testing personnel

Accepted Answer

CLIA '88 regulations specify that laboratories performing moderate-complexity testing only must have a laboratory director, technical consultant, and clinical consultant in addition to the personnel performing the test.

Question 14

Which of the following would be a negative aspect of a reagent rental plan for acquiring a piece of equipment, as compared to leasing equipment?

Accepted Answer

In a reagent rental agreement, the laboratory agrees to purchase a minimum amount of testing materials at a negotiated cost for an agreed period of time.Although this agreement does include the use of the equipment (which is included in the cost of the agreement), there are many downsides to this approach to acquire new equipment for the laboratory.These include the fact that next-generation equipment may become available from a different company before the contract expires, limiting the laboratory's option.Additionally, the test volume may decrease for the equipment before the reagent rental contract expires, obligating the laboratory to costs that cannot be recovered.Also, if cash flow is a problem, a true lease may be preferred, where a monthly capital cost is billed along with the reagent cost.

Question 15

Based on CLIA '88 regulations, which of the following are permitted to evaluate the competency of all testing personnel?
1)the laboratory director
2)the technical consultant
3)the technical supervisor
4)the general supervisor

Accepted Answer

Although the laboratory director has ultimate responsibility for ensuring the competency of all testing personnel, under CLIA '88, the laboratory director, technical consultant, technical supervisor, or general supervisor can evaluate the competency of testing personnel.

Question 16

Frequent budget analysis is an important function of the laboratory manager.The type of budget analysis that involves a comparison of the current month's actual dollars spent versus the budgeted dollars is known as a ______ analysis.A budget analysis that compares the current month's actual dollars spent per test with the budgeted dollars per test is a ______ analysis.Of these two, the ______ analysis excludes variances in test volumes.

Accepted Answer

Two types of budget analysis can be performed: static and flexible.A budget analysis that involves a comparison of the current month's actual dollars spent versus the budgeted dollars is known as a static analysis.A budget analysis that compares the current month's actual dollars spent per test with the budgeted dollars per test is known as a flexible analysis.Of the two, a static analysis excludes variances in test volumes.

Question 17

A Laboratory Response Network is:

Accepted Answer

The Laboratory Response Network (LRN) is a collaborative effort between the CDC, FBI, public health laboratories, and many other local, state, and federal laboratories to respond to large-scale emergencies that may exceed a given laboratory's capacity alone.The objective of the Network is to have the necessary national infrastructure to respond to large-scale emergencies.

Quiz 19: Laboratory Management