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
What is the purpose of laboratory Compliance Plans?
to assist hospitals, health systems, and their agents in devising internal controls that effectively foster adherence to applicable federal and state laws and regulations to program requirements of federal, state, and private health plans.
What are the seven primary principals and elements of a lab Compliance Plan?
- Written policies, procedures, and standards of conduct that promote the lab’s commitment to compliance.2. A chief compliance officer and compliance committee with overall responsibility for developing, monitoring, updating, and enhancing the program.3. education and training of all employees4. ways that individuals can report suspected compliance violations anonymously5. a system to respond to allegations of illegal or improper activities and take appropriate disciplinary action against employees involved.6. internal monitoring, audits, and other evaluative methods to assess compliance efforts and reduce problems.7. investigation and correction of identified problems, as well as development of policies governing employment or retention of individuals sanctioned for healthcare fraud.
What codes are important for identification of medical necessity?
ICD-9 codes (soon ICD-10)
What is one thing the lab can do to assist with monitoring medical necessity?
the lab can develop a method to monitor test utilization over time to ensure that physicians are ordering only medically necessary tests.
Who is responsible for identification of appropriate ICD-9 codes?
the lab should only use ICD-9 codes obtained from the ordering physician.
What codes are used to designate diagnostic information?
ICD-9 or ICD-10
True or False: Laboratories should use past information or computer programs that automatically insert ICD-9 codes without physician information.
False
True or False: Laboratories should only bill for appropriate automated multi-channel chemistry tests.
True
True or False: Laboratories should only bill for tests that were both ordered and performed.
True
True or False: Laboratories are permitted to perform ‘standing orders’.
True, but the lab must monitor their continued validity.
Describe the Stark Law.
The Stark law prohibits a physician from making referrals for the furnishing of lab testing to a lab with which the physician or a family member has a financial relationship.
True or False: The Stark Law allows for physicians to refer lab testing to a lab in which the physician has a financial relationship.
False
True or False: A ‘group practice’ may allow a group of physicians to qualify for certain exceptions to the Stark Law.
True
True or False: The Stark Law applies to Medicare and medicaid patiently only.
True
True or False: The Stark Law allows labs to supply items to be used solely to collect or process specimens.
True
True or False: The Stark Law does NOT allow laboratories to supply equipment to physicians solely to communicate test results.
False
Who does the Anti-Kickback Statute penalize?
The anti-kickback statute penalizes anyone who knowingly solicits, receives, offers, or pays remuneration in cash or in kind support for referring patients for lab testing.
Describe an inducement.
An inducement maybe anything of value not paid for at a fair market value.
Does the Anti-kickback statute apply to Medicare and Medicaid services?
Yes
Is this an example of an Anti-kickback statute violation?A phlebotomist performing other duties besides phlebotomy such as taking vital signs or other nursing functions.
Yes
Is this an example of an Anti-kickback statute violation?A laboratory providing free pick-up and disposal of biohazardous waste unrelated to specimen collection.
Yes
Is this an example of an Anti-kickback statute violation?A laboratory providing free pick-up and disposal of biohazardous waste related to specimen collection.
No.
Is this an example of an Anti-kickback statute violation?Provision of computers used exclusively for the performance of laboratory work.
No.
Is this an example of an Anti-kickback statute violation?Provision of computers and fax machines, unless used exclusively for the performance of outside laboratory work.
Yes
Is this an example of an Anti-kickback statute violation?Providing free laboratory testing for physicians, their employees or family members.
Yes.
What is HIPAA?
Health Insurance Portability and Accountability Act of 1996.
When was HIPAA passed?
August 21, 1996
What is another name for the 1996 HIPAA?
“Privacy Rule” or Standards for Privacy of Individually Identifiable Health Information.
What did the Standards for Privacy of Individually Identifiable Health Information establish?
for the first time, there is a set of national standards for teh protection of certain health information.
What is included in protected health information?
- the individual’s past, present, or future physical or mental health or condition.2. the provision of health care to the individual.3. the past, present, or future payment for the provision of health care to the individual, and that identifies the individual.
What common identifiers are included as identifiable health information?
name, address, birth date, social security number
What covered entities are subject to the Privacy Rule?
Health care clearinghousehealth plan companieshealth care providers
Under what circumstances is a laboratory considered a health care provider and subject to the Privacy Rule?
A lab is considered a covered entity if it conducts one or more covered transactions electronically, such as submitting health care claims or equivalent information to a health plan, requesting prior authorization, or sending eligibility inquiry to a heath plan to confirm the individual’s coverage under that plan.
How many days after a patient requests access their health information does the provider have to comply?
30 days
What is required by a provider if they cannot give a patient access to their health information within the 30 day timeframe?
A covered laboratory may request one 30-day extension, if it provides the reason for the delay in writing to the requesting individual.
How many extensions does the HIPAA Privacy Rule allow for an access request?
one
True or False: An individual has the right to access his or her protected health information from both the referring laboratory and the laboratory that performed the test in the instance that a lab refers the specimen to another laboratory.
True
True or False: When an individual requests protected health information, a laboratory is required to interpret the test results for the patient.
False
What is a Confidence Interval?
A confidence interval is an estimated range of values calculated from the mean and standard deviation. It estimates the statistical probability of values falling above or below the mean value on a normal bell-shaped Gaussian curve. Often expressed as a percentage.
What does a Confidence Interval estimate?
the statistical probability of values falling above or below the mean value on a normal bell-shaped Guassian curve.
Given a mean (X) of 9.8 and a standard deviation (SD) of 0.2, calculate the 95% CI for the control.
= X + 2 SD= 9.8 + 2 (0.2)= 9.8 + 0.4= 9.8- 0.4 = 9.4=9.8 + 0.4 = 10.2
What is the formula for a 68% Confidence Interval?
X + 1 = 68%
What is the formula for a 95% Confidence Interval?
95% = X + 2 SD
What is the formula for a 99% Confidence Interval?
99% = X + 3 SD
What is the coefficient of variation (CV)?
ratio of the standard deviation to the arithmetic mean
What is the formula for Coefficience of Variation (CV)?
CV = (SD/mean) x 100
What is the calculated coefficient of variation for the following:mean = 200SD = 5
CV = (SD/mean) x 100= (5/200) x 100= 2.5%
What is standard deviation (SD)?
the root mean square deviation of the values from their mean;orthe square root of the variance
Define a Chain of Custody.
Chain of custody refers to the chronological documentation, and/or paper trail, showing the procurement, custody, control, transfer, analysis, and disposition of the specimen.
What is the purpose of a chain of custody?
a chain of custody form is required for any specimen used as legal evidence in court.
Describe a Competency Evaluation.
A competency evaluation is a process of documenting, usually in measurable terms, the employee’s technical skills. Should be done annually.
How often should employee competency be evaluated?
annually
Describe Accreditation.
Accreditation is a voluntary process by which a non-governmental agency grants recognition to an organization that has achieved a set of predetermined standards.
Describe Licensure.
Licensure is a mandatory process by which some states grant permission to an individual or organization to engage in a given occupation.
Computer Network
collection of computers and other hardware interconnected by communication channels that allow sharing of resources and information.
Network
collection of computers and other hardware interconnected by communication channels that allow sharing of resources and information.
LAN
Local Area Network
Local Area Network
computer network that interconnects computers in a limited area such as a health care facility, using network media.
HIS
Hospital information system
Hospital Information System
comprehensive, integrated information system designed to manage the medical, administrative, financial, and legal aspects of a hospital and its service processing.
LIS
Laboratory Information System
Laboratory Information System
series of computer programs that process, store, and manage data from all stages of laboratory process
EMR
Electronic Medical Record
Electronic Medical Record
computerized medical record created in a health care organization
intranet
computer network that uses internet technology to share information, operational systems or computing services within an organization
HTML
HyperText markup Language
HyperText Markup Language
main markup language for displaying web pages and other information that can be displayed in a web browser.
What is the main markup language that can be used to display web pages and other information to be displayed in a web browser?
HyperText Markup Language (HTML)
HTTP
HyperText Transfer Protocol
HyperText Transfer Protocol
HTTP is an application protocol for distributed, collaborative, hypermedia information systems. it is the foundation of the world wide web.
CPOE
Computerized Provider Order Entry (CPOE)
Computerized Provider Order Entry (CPOE)
CPOE is a computerized process for health care providers to electronically enter and order medical procedures and laboratory tests based on a predetermined algorithm.
CPT
Current Procedural Terminology
What is the purpose of Current Procedural Terminology (CPT) codes?
The purpose of CPT is to provide a uniform language accurately describing medical, surgical, and diagnostic services.
Do CPTcodes serve as a type of communication nationwide within the health care industry?
yes
Name two reason that a CPT code might have a modifier.
- a service or procedure has both a technical and professional component2. a service or procedure was performed by more than one physician and/or in more than one location
What does a -26 CPT code modifier stand for?
26 - Professional Component
What does a -59 CPT code modifier stand for?
59 - Distinct Procedural Service
What does a -91 CPT code modifier stand for?
91 - Repeat Clinical Diagnostic Laboratory Test
In the interpretation of a Levey-Jennings plot, what does shift refer to?
6 consecutive points on one side of the mean
In the interpretation of a Levey-Jennings plot, what does trend refer to?
6 consecutive points increasing or decreasing that may cross the mean
What three types of error are included as sources of variation?
- sample error2. random analytical error3. operatory error
What are the six sources of variation?
- sample error2. random analytical error3. operatory error4. method or instrument bias5. sample or day-to-day variation within a single patient6. patient (race, sex, age, health status)
What is a laboratory’s main method for external quality control?
Proficiency Testing
What does proficiency testing verify?
A laboratory’s accuracy
Proficiency testing specimens should be testing by whom in the lab?
routine testing personnel during routine testing
Should proficiency testing samples be tested with patient samples?
yes
Should aliquotes of proficiency samples be saved?
yes, in the case that a re-assay is necessary
Define a reference range.
A reference range is a collection of normal values for a constituent of clinical interest.
What did CLIA ‘88 establish?
CLIA ‘88 established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.
When did the final CLIA laboratory regulations become effective?
2003
What governmental agency was responsible for publishing the final CLIA regulations in 2003?
Centers for Medicare and Medicaid Services (CMS)
How long are CLIA certificates effective?
2 years
Where could one find a complete list of CLIA waived tests?
www.fda.gov
What three types of records must be retained for 2 years according to CLIA ‘88?
- QC2. patient test records3. quality assessment records
What is included as part of an original report, according to CLIA ‘88?
final, preliminary, and corrected reports
Do laboratory’s that close down or cease operation have to make provisions to ensure that records, blocks, and slides are available for the determined record retention requirements?
yes
What does CLIA ‘88 consider a device?
Instrument, kit, or test sytem
What CFR regulation is related to OSHA?
CFR 1910.1030
CFR
Code of Federal Regulations
How long must the record of training for shipping of infectious substances be retained following employee termination?
1 year
OHSA
Occupational Safety and Health Administration
GHS
The Globally Harmonized System of Classification and Labelling of Chemicals
What is GHS?
The Globally Harmonized System of Classification and Labelling of Chemicals is a system for standardizing and harmonizing the classification and labelling of chemicals.
The GHS document is also referred to as what?
The Purple Book
What was the international madate?
The single most important driving force behind the creation of the GHS (Global Harmonized System of Classification and Labelling of Chemicals)
When was the International Mandate, which was responsible for the creation of the GHS (Global Harmonized System of Classification of Chemicals) adopted?
1992 at the United Nations Conference on Environment and Development (UNCED)
What is another name for the United Nations Conference on Environment and Development (UNCED), where the International Mandate was created?
Earth Summit
When was the first version of the GHS formally adopted?
December 2003
When was the GHS first endorsed and by whom?
The GHS (Globally Harmonized System ofClassification and Labeling of Chemicals) was endorsed in July 2003 by the UN Economic and Social Council.
What more recently adopted hazardous chemical labeling requirements has OSHA used to align with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS)?
Hazardous Communications Standard (HCS), 29 CFR 1910.1200
What rule did OSHA publish in 1990 which requires laboratories to ensure that exposure to hazardous chemicals are within permissible exposure limits (PELs)?
Occupational Exposures to Hazardous Chemicals in Laboratories
What are five examples in which one would need a chain of custody?
- legal blood alcohol to prosecute DUI cases2. DOT drug testing3. paternity testing4. DNA analysis5. rape cases
Name two examples of common reflex tests?
- positive sickle screen reflexes to Hgb electrophoresis2. positive ANA (antinuclear antibodies - allergies) test reflexes an ANA profile3. positive urinalysis results to a urine culture
What is the definition of reflex testing?
The test is performed on a patient sample only after a particular analyte is abnormal or outside of a predetermined range.
CPT
Current Procedural Terminology
Name two major components of pre-analytical testing.
- lab requisition
2. specimen collection, transport, storage
Name three major components of analytical testing.
- calibration
- QC
- specimen integrity
Name two major components of post-analytical testing.
- test records
2. test report
