CLS 365 UNIT 2 EXAM Compliance, Managerial Functions & Problem Solving

what does CLIA’88 regulate?

regulates all laboratory testing used for diagnosis, monitoring, prevention or treatment

what does CLIA’88 establish?

establishes quality standards for all laboratory testing to ensure accuracy, reliability and timeliness of patient test results

what does test site neutral mean regarding CLIA’88? (learning objective; ch.15)

same regulations apply regardless of the location of testing

what are the 7 things centers for medicare and medicaid services (CMS) is responsible for?

1. registering laboratories for CLIA certificates

   • all lab testing must be done under an appropriate CLIA certificate

2. fee collection

3. onsite inspection surveys

4. surveyor guidelines and training

5. approving proficiency testing providers

6. deeming professional accreditation organizations and exempting states

7. enforcement actions when needed

lab testing requirements are based on the complexity or difficulty to perform a test method

what are the three categories that CLIA regulations divide test methods into? (learning objective; ch.15)

1. waived

2. moderate complexity

   • provider performed microscopy procedures (PPMP)

3. high complexity

what are the 5 CLIA certificate? (learning objective; ch.15)

1. waiver

2. provider

3. registration (temp certification)

4. compliance

5. accreditation

test complexity will determine the type of CLIA certificate a lab will get

what is the waiver certificate? (learning objective; ch.15)

permits a site to perform only those tests methods identified as waived

what is the provider certificate? (learning objective; ch.15)

performed microscopy registration (PPMP) → certificate issued to a laboratory for physicians, midlevel practitioners, or dentists to perform PPM procedures or those tests on specimens collected during a physical examination and waived tests

what is the registration certificate? (learning objective; ch.15)

a certificate issued to enable laboratories to conduct waived, moderate, and/or high complexity laboratory testing and is a temporary certificate

what is a compliance certificate? (learning objective; ch.15)

obtained once the laboratory is inspected and judged → in compliance with the requirements, this temporary registration and is replaced with a permanent “compliance” certificate

what is an accreditation certificate? (learning objective; ch.15)

issued to those laboratories seeking accreditation from a CMS and is deemed professional organization when found in compliance with the accrediting organization’s requirements

how does CLIA defined “waived” as? (learning objective; ch.15)

• test cleared by the FDA for home use

• tests using such simple and accurate methodologies that the likelihood of erroneous results is negligible

• pose no reasonable risk of harm to the patient if the test is performed incorrectly

what are the seven criteria that is used to grade the level of complexity for a specific laboratory test or methodology?

1. knowledge

2. training and experience

3. reagents and materials preparations

4. characteristics of operational steps

5. calibration, quality control, and proficiency testing materials

6. test system troubleshooting and equipment

7. interpretation and judgment

what are the four positions that have proper qualifications that must be on sites that perform moderate complexity training?

1. director

2. technical consultant

3. clinical consultant

4. testing personnel

what is the “director” and what are their qualifications regarding personnel for moderate complexity testing?

can range from a physician to an individual with a bachelor’s degree in medical technology/CLS or a degree in chemical, physical, or biological science AND has 2 years of lab training/experience AND has 2 years of lab supervisory experience

what does a “clinical consultant” do and what are their qualifications regarding personnel for moderate/high complexity testing?

serves as the liaison (close connection) between the lab and its customers and must be qualified to consult with clinicians and patients and give opinions concerning the diagnosis, treatment, and management of patient care

• MUST BE a clinician, or have a doctorate in chemical, physical, biological, or CLS/MLS

what does a “technical consultant/technical supervisor” do and what are their qualifications regarding personnel of moderate/high complexity testing?

establishes the quality standards of the lab through selecting and monitoring the laboratory’s methods/instruments, and evaluating and documenting the competency of the personnel annually

• range from clinician to an individual possessing a bachelor’s degree in chemical, physical, biological, or CLS/MLS AND one year of lab training or experience in the designates specialty of responsibility

  • in technical supervisor, the training and/or experience is specified

what are testing personnel responsible for in moderate complexity testing? what are their qualifications?

responsible for specimen processing, test performance, and reporting test results

• minimum → high school education (or equivalent), plus appropriate director-approved training and ongoing competency assessment at least once per year

what are the five positions that have proper qualifications that must be on sites that perform high complexity training?

1. director

2. clinical consultant

3. technical supervisor

4. general supervisor

5. testing personnel

what does the “director” do and what are their qualifications regarding personnel for high complexity testing?

responsible for overall operation and administration of the laboratory

• qualifications → licensed physician with lab training or experience or have a doctorate in chemical, physical, biological, or CLS/MLS

• those who are hired after 02/24/03, the individual must have Health and Human services (HHS) approved board certification or be qualified as a direction or or before 02/28/92

what does the “general supervisor” do and what are their qualifications regarding personnel for high complexity testing?

provides day-to-day supervision of testing personnel and reporting of results

• qualifications → range from individuals who qualify as a clinical to persons possessing an associate degree in CLS/MLS or and two years of laboratory training and experience

what are testing personnel qualifications for in high complexity testing?

at least possess an associate degree in CLS/MLS, or an education and training equivalent to an associate degree

what role does proficiency testing play in the lab under CLIA? (learning objective, ch.15)

evaluating test result quality for CLIA-regulated analytes in test sites performing moderate and/or high complexity testing

who published the quality systems for nonwaived testing and what does quality systems for nonwaived consist of? what path does it follow? (learning objective, ch.15)

• published by CMS in the final rule to CLIA in 2003 and consists of most of the moderate and high complexity quality requirements into one set of requirements

• quality requirements are organized to follow the path of patient specimens through the testing process → preanalytical, analytical, and postanalytical

what is method verification for unmodified, FDA-approved, nonwaived test methods?

collecting data that document the method’s performance in the test site by the site’s analysts

what are the performance characteristics that need to be evaluated in method verification?

accuracy, precision, reportable range, and identification of appropriate reference intervals

what is the lab responsible for regarding quality control for nonwaived testing?

responsible for having control procedures that monitor the accuracy and precision of the complete analytical process

what must the control procedures do regarding quality control for nonwaived testing?

1. detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance

2. monitor overtime the accuracy and precision of test performance

CLIA requires test sites to analyze, for most analytes, at least two levels of external, liquid QC per test per day of testing

what does CLIA require for sites performing moderate and high complexity tests?

to be inspected every two years for compliance to the regulation and are unannounced and conducted while the lab’s CLIA certificate is still valid

what does CLIA regulations allow CMS to approve regarding voluntary accreditation?

allows CMS to approve nonprofit, professional organizations having laboratory testing and inspection standards that are essentially equivalent to, or more stringent than, those of CLIA

what is the Joint Commission? (learning objective; ch.15)

a voluntary organization that accredits more than 80% of US healthcare organization and their testing standards focus on quality improvement and designed to promote quality outcomes

inspection for compliance is conducted every two years

what does the laboratory accreditation program of the College of American Pathologists only do? (learning objective; ch.15)

accredits only laboratory testing sites and not the entire healthcare organization

all test sites must follow the lab general (GEN) and common (COM) checklists along with the specific checklists appropriate to the specialty of testing

what must labs follow regarding the laboratory accreditation program of the College of American Pathologists (LAP-CAP)? (learning objective; ch.15)

must follow specific QC, procedure manual, method performance specification validation, accuracy assessment, method correlation requirements specified in CAP checklists → many are similar or same to CLIA’88

LAP-CAP prefers to see pathologists as lab directors

how does COLA (formerly known as the commission of office lab accreditation) prepare labs for the accreditation process? (learning objective; ch.15)

provides sites with an initial, preinspection (self-inspection) checklist which the COLA inspector uses the same checklist during the on-site inspection

cola’s philosophy is one of education and problem solving

what is the U.S department of labor, under OSHA, responsible for?

responsible for regulations relating to general workplace safety and protecting the health of US workers

what is OSHA’s standard precautions? (learning objective; ch.15)

all blood, body fluids, tissue and other potentially infectious materials be treated as equally hazardous

what must facilities must have in place, develop, and implement regarding OSHA? (learning objective; ch.15)

must have in place a classification system for each job based on the level of exposure to blood-borne pathogens and must develop and implement procedures that are in compliance with OSHA regulations to protect workers and minimize the risk of exposure

upon employment, what must employees participate in regarding OSHA?

must participate in an on-the-job training program that minimally covers the facility’s exposure control plan, use of PPE, and procedures to be followed in the event of exposure to a blood-borne pathogen

what is the primary goal of HIPAA (health insurance focused legislation)? (learning objective; ch.15)

make it easier to detect and prosecute fraud and abuse, and enable workers of all professions, even those with pre-existing medical conditions, to change jobs without loss or interruption of health insurance protection

larger institutions are required to have a HIPAA privacy officer to provide information

what is the definition of problem solving? (learning objective; ch.4)

process of identifying and defining the problem, determining what happened to cause it, and what steps or possible solutions will be necessary to solve it

what is the definition of decision making? (learning objective; ch.4)

process of choosing among several alternatives and is a management function

what are the steps in problem solving?

1. problem identification

2. problem analysis

3. criteria establishment

4. alternative development and decision making

5. problem solution and feedback

what is the problem identification step?

process that emphasizes the detailed analysis of the problem before discussion of solutions and a systematic evaluation of alternatives

a problem exists when there is a discrepancy between what one would like to happen and what is actually happening

what is problem analysis step?

after evidence has been collected, the problem identified and defined, attention turns to analyzing the evidence more thoroughly, and looking for relevant data that may explain why the problem exists

• in problem analysis, it is a matter of evaluating the data that has been collected in step one and the sources from which that data comes

what are the components in criteria establishment step?

1. what the decision has to accomplish

2. what minimum goals must be attained

3. what objectives the decision has to reach

4. what conditions it has to satisfy

what is alternative development and decision making step?

appropriate solutions and alternatives are developed and each alternative can be ranked based on its advantages and disadvantages, weaknesses and strengths, and how well it meets the objective

what is problem solution and feedback step?

converting the decision into action where an action plan must be written that details the steps that need to be taken to implement the solution and identify the resources required to do it

what is decision making the process of?

process by which managers respond to opportunities and threats by analyzing option and making decisions about goals and courses of action and is an important skill a leader can acquire

what are the 8 decision making traps?

1. anchoring trap

2. status-quo-trap

3. sunk-cost trap

4. confirming-evidence trap

5. framing trap

6. overconfidence trap

7. prudence trap

8. recallability trap

what is the anchoring trap? (learning objective; ch.4)

• when information is given up front that later affects the decision that is made

• when considering a decision, the mind gives disproportionate weight to the first information it receives

• initial impressions, estimates, or other data anchor subsequent thoughts and judgments

what is the status-quo trap? (learning objective; ch.4)

decisions which involve the least change

individuals like what is the most familiar → become complacent and avoids rocking the boat

what is the sunk-cost trap? (learning objective; ch.4)

escalation of commitment because of an individual’s past decisions

• ex = manager is on a certain course and does not want to turn back, even though goals may no longer be valid

what is the confirming-evidence trap? (learning objective; ch.4)

mental bias that leads managers to seek out information to support their existing point of view while avoiding information that contradicts it

people have a tendency to subconsciously decide what they want to do, before they figure out why they want to do it

what is the framing trap? (learning objective; ch.4)

how you view your choices or how you frame the questions around the problem → a frame can establish the status-quo, introduce an anchor, lead a manager to justify past actions, or highlight confirming evidence

what is the overconfidence trap? (learning objective; ch.4)

managers believe that they are better at making forecasts or estimates than they actually are → will set too narrow of a range of possibilities

what is the prudence trap? (learning objective; ch.4)

happens when managers are overly cautious or prudent in forecasting and will adjust forecasts or estimates “just to be on the safe side” → looking for the worst case scenario and making decisions based upon that scenario

can be just as damaging as being overconfident

what is the recallability trap? (learning objective; ch.4)

represents an association bias “well it worked before” mentality → managers will get caught up in the past and predict the future based upon past experiences which left a strong impression

what is group decision-making based on and what does it involve?

based on the concept that when people identify their personal goals with goals of an organization, they release an enormous amount of energy, creativity, and loyalty and involves other individuals and groups in the decision-making process

what is the autocratic decision making style?

decisions are made without consulting others

what is the consultative decision making style?

suggestions and ideas from the team members are obtained but the decision made may or may not reflect their input

what is the joint (also called democratic style) decision making style?

involves sharing the of decision making in an attempt to reach consensus on a decision

what is the delegation decision making style?

the decision or problem is turned over to the group without the involvement of the manager/leader

what is the shewhart cycle? describe the steps (learning objective; ch.4)

involves four steps: plan, do, check, act (PDCA)

1. plan = team identifies the real problem and spends time defining and analyzing the nature of the problem → how the problem is defined will affect the kinds of solutions that are seen

2. do = team will implement the improvement effort they planned using a small-scale test → essentially testing the hypothesis

3. check = data is collected and analyzed and the results are studied to see if the process was improved → team members can evaluate and examine any variables present in the process and collect new data and compare it against the old data

4. act = plan is implemented and monitored

what are the steps in plan?

1. describe the process

2. review existing information

3. identify customers

4. select appropriate strategies to gather meaningful data

5. interview customers

6. plot process using a flow chart

7. brainstorm problem and produce a fishbone diagram

   • fishbone diagram helps find the root cause of a problem by breaking the big problem into smaller possible causes

8. collect data on the process

9. analyze the data and develop a hypothesis or theory

what is the LEAN methodology?

continual process of improvement that when applied to the lab, its main objective is to “deliver quality patient laboratory results, at the lowest cost, within the shortest time frame while maintaining client satisfaction.”

standardized the way that a group works and eliminate waste → ex. non-value-added steps in the labs processes to improve efficiencies

what are the 5 LEAN techniques?

1. identify value

2. map the value stream

3. create flow

4. establish pull

5. seek perfection

what is identify value in lean methodology?

specify what creates value from the customer’s perspective

what is map the value stream in lean methodology?

identify all the steps along the process chain, eliminating, whenever possible, those steps that do not create value

what is create flow in lean methodology?

make the process flow so the product or service will flow smoothly toward the customer

what is establish pull in LEAN methodology?

introduce a continuous flow of events between all steps of the process where possible

what is seek perfection (continuous improvement) in LEAN methodology?

begin the process again and continue it until a state of perfection is reached in which perfect value is created with no waste

what are the tools that are used to remove waste and establish a LEAN laboratory?

• value stream mapping

• 5S workplace organization

• visual workplace

• work cell specimen processing

what is value stream mapping?

direct observation of the lab process and identification of where waste is found in process → current process is examined and documented from start to finish and “future-state” maps are developed to show how the operation would look, IF ONLY staff did that which was necessary to complete the work based on high-quality standards

what is 5S workplace organization?

emphasizes the maintenance of an orderly workplace

what are the 5S’ in workplace organization? describe them

1. sort = proper arrangement of all items, storage, equipment, tools, inventory and traffic

2. set (or simply) = orderliness

   • ex. determine the best place to keep the items that are used regularly

3. shine = cleanliness

   • keep the work area clean

4. standardize = make things common and consistent

5. sustain (or self-discipline) = maintaining

what is visual workplace?

concept of creating a workplace that is entirely visually instructive

visual cues reduce the amount of wasted time that is spent searching, looking, and waiting

what is work cell specimen processing?

physical or logical layout of all testing and processing equipment, technicians, machines, and materials through which a specimen flows

work cell minimizes movement, reduces batch sizes, decreases set-up time for testing, improve lab safety, and standardize work processes with visual cues

what is six sigma DMAIC methodology? what is contained in it?

roadmap for problem solving and product/process improvement

• define

• measure

• analyze

• improve

• control

what is define in six sigma DMAIC methodology?

defines who the customers are, what their requirements are for products and services, and what are their expectations; also defines project boundaries, the stop and start of the process

what is measure in six sigma DMAIC methodology?

measures the process to determine current performance which develops a data collection plan for the process, collecting data from many sources to determine types of defects and metrics, and comparing to customer survey results to determine shortfall

what is analyze in six sigma DMAIC methodology?

• analyzes data collected and processes map to determine root causes of defects and opportunities for improvement

  • identifies gaps between current performance and goal performance

  • prioritizes opportunities to improve

  • identifies sources of variation

what is improve in six sigma DMAIC methodology?

process is improved by eliminating defects → uses creative solutions to fix and prevent problems, creating innovative solutions using technology and discipline, and developing and deploying an implementation plan to the targeted process

what is control in six sigma DMAIC methodology?

improvements are controlled to keep the process on the new course and to prevent reverting back to the “old way” and involves the development, documentation, and implementation of an ongoing monitoring plan

what are the 8 decision making strategies & tools?

1. benchmarking

2. brainstorming

3. scatter diagrams

4. pareto charts

5. PMI (plus/minus/interesting)

6. decision trees

7. fish bone/honeycomb cause and effect

8. cost-benefit analysis

what is the benchmark strategy?

an organization can determine a measure of its processes against those of recognized leaders in the field, and how it measures up to the standard set by those leaders

organizations usually establish performance indicators in four categories: cost effectiveness, staff productivity, process efficiency, and cycle time

what is the brainstorming strategy?

method for developing creative solutions to problems and the idea of it is to generate, clarify, and evaluate a sizable list of ideas, problems, or issues

what is the PMI strategy?

when faced with a difficult decision, a table is created with the categories: plus, minus, and interesting

whats a decision-making tree and when would it be used?

a graphical diagram consisting of nodes and branches

• if there are certain alternative choices that are clear but consequences of the choices are readily apparent, a decision tree would be used

what is the fishbone/honeycomb cause and effect strategy?

fishbone diagram systematically analyzes cause and effect relationships and identifies potential root causes of a problem → used to display the relationships between a given effect and its potential causes

what is the cost-benefit analysis strategy?

refers to the several approaches for determining and comparing the forward looking, incremental costs, benefits, and values of solution alternatives → determines whether the results of a particular course of action are of sufficient benefit to justify the cost of taking the action

what is the management function, planning?

clarifies the process of attaining the desired goals of an organization and includes activities such as data gathering, assessment, calculation of risks, and determination of a strategy

what are the 5 major components of the planning function?

1. vision

2. mission

3. objectives

4. goals

5. tactics

what should the mission and vision statement be?

clear and conveys the direction of the organization

what is the mission statement as a major component of planning?

defines the organization’s purpose and primary objectives

what is vision statement as a major component of planning?

define the organization’s purpose, but in terms of the organization’s values

what is goals as a major component of planning?

helps institutions define its mission, control its destiny, motivate its employees, and ensure that everyone understands the purpose of the enterprise

what are objectives as a major component of planning?

tangible plans that are usually expressed as results to be achieved and may be expressed quantitatively or qualitatively

what are tactions as a major component of planning?

most specific plans that describe how, who, what, when, and where activities will take place to accomplish a goal

what are the steps in decision making?

1. defining the problem

2. analyzing the problem

3. developing alternative solutions

4. evaluating the alternatives

5. making a decision between the alternatives

6. follow-up assessment after the decision has been implemented

what is organizing as a management function?

process of determining the steps needed to implement a successful plan