Which of the following is the category of CLIA testing that is simple unvarying and requires a minimum of judgment and interpretation?

Original Eight Tests Approved in 1988

Hematology

83026
Hemoglobin by copper sulfate—nonautomated
Monitors hemoglobin level in blood

85013
Blood count; spun microhematocrit
Screen for anemia

85651
Erythrocyte sedimentation rate—nonautomated
Nonspecific screening test for inflammatory activity, increased for majority of infections and most cases of carcinoma and leukemia

Chemistry

82962
Blood glucose by glucose monitoring devices cleared by the FDA for home use
Monitoring of blood glucose levels

Urine and Feces

81002
Dipstick or tablet reagent urinalysis—nonautomated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen
Screening of urine to monitor or diagnose various diseases and conditions such as diabetes, the state of the kidney or urinary tract, and urinary tract infections

81025
Urine pregnancy tests by visual color comparison
Diagnosis of pregnancy

84830
Ovulation tests by visual color comparison for human luteinizing hormone
Detection of ovulation (optimal for conception)

82270 GO 107 (Contact Medicare carrier for claims instructions.)
Fecal occult blood
Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)

Examples of More Recently Approved Waived Tests

Hematology

85014QW
STAT-CRIT/hematocrit
Screen for anemia

85018QW
HemoCue Hemoglobin system
Measures hemoglobin level in whole blood

 
GDS Diagnostics HemoSite Meter
 

Blood Chemistry

82365QW (Contact Medicare for claims instructions.)
Cholestech LDX
Measures total cholesterol, high-density lipoprotein cholesterol, triglycerides, and glucose levels in blood

82947QW
HemoCue B—glucose photometer
Measures glucose levels in whole blood

83036QW
Bayer DCA 2000—glycosylated hemoglobin (Hgb A1c)
Measures percent concentration of hemoglobin A1c in blood, which is used in monitoring the long-term care of people with diabetes

80053QW
Blood Chemistry Analyzer
Measures alanine amino transferase (ALT), aspartate amino transferase (AST), albumin, total bilirubin, total calcium, carbon dioxide, chloride, creatinine, glucose, alkaline phosphatase, potassium, total protein, sodium, and urea nitrogen in whole blood

Drug Screening

80101QW
Multiple Drug Cup Test
Screening test to detect the presence of amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol (THC), cocaine metabolites, methadone, methamphetamines, opiates, oxycodone, and phencyclidine (PCP) in urine

Immunology/Serology

86308QW
Rapid whole blood mononucleosis tests
Qualitative screening test for the presence of heterophile antibodies to aid in the diagnosis of infectious mononucleosis

86318QW
Rapid whole blood test for Helicobacter pylori antibodies for determining the possible cause of peptic ulcers
Immunoassay for rapid, qualitative detection of immunoglobulin G antibodies specific to H. pylori

86618QW
Rapid whole blood test for Borrelia burgdorferi (causative agent of Lyme disease)
Qualitative detection of immunoglobulin G and M antibodies to B. burgdorferi

86701QW
OraSure OraQuick Rapid HIV-1 antibody test with whole blood
Qualitative immunoassay to detect antibodies to HIV-1 in fingerstick and venipuncture whole blood specimens

Microbiology

87804QW
Quick influenza A and B test
Qualitative detection of influenza type A and B antigens in nasal wash and nasopharyngeal swab specimens

87889QW
Quick Streptococcus A test
Rapidly detects Streptococcus A antigen from throat swabs as an aid in the diagnosis of strep throat, tonsillitis, and scarlet fever

Urinalysis

81003QW
Bayer Clinitek 50 Urine Chemistry Analyzer—qualitative dipstick for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leukocytes (automated)
Screening of urine to monitor or diagnose various diseases and conditions such as diabetes, the state of the kidney or urinary tract, and urinary tract infections

82044QW
Bayer Clinitek 50 Urine Chemistry Analyzer—microalbumin, creatinine
Semiquantitative measurement of microalbumin and creatinine in urine for the detection of patients at risk for developing kidney damage

Question:

- issued by the CDC
- intended to protect all health care providers, patients, and visitors from infectious diseases

Answer:

Standard Precautions

Question:

- designed to reduce the risk for airborne, droplet, and contact transmission of pathogens
- used in addition to Standard and are intended for specific categories of patients.

Answer:

Transmission-Based Precautions

Question:

- purpose was to assist health care providers to greatly reduce the risk for contracting/transmitting infectious diseases
- particularly AIDS and hepatitis B

Answer:

Universal Blood & Body Fluid Precautions (Universal Precautions)

Question:

- Safeguards the public by regulating all testing of specimens taken from the body

Answer:

CLIA ('88)

Question:

- Requires employers to ensure employee safety in regard to occupational exposure to potentially harmful substances

Answer:

OSHA

Question:

What was designed to set safety policies and procedures that protect patients?

Answer:

CLIA

Question:

The intent of CLIA '88 is to protect the public by regulating all laboratory tests performed on specimens taken from the human body that is tissue, blood, and body ______ and _______, which are used in the diagnosis, treatment, & prevention of disease.

Answer:

secretions and excretions

Question:

All laboratories, including POLs, must abide by the ______ law.

Answer:

CLIA

Question:

CLIA regulations are based on the complexity of tests performed and they affect all aspects of the lab. They specify the type of test performed, personnel involved in testing, and ________ ________.

Answer:

quality control

Question:

A _______ is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing info for the diagnosis, prevention, or treatment of disease, or impairment or assessment of health.

Answer:

laboratory

Question:

CLIA, under the aegis of the CMS designated which 3 categories of testing?

Answer:

Waived 2. Moderate-complexity tests, including PPMP 3. High-complexity tests

Question:

________ tests are:

- simple
- unvarying
- require minimum of judgement and interpretation
- test error carries minimal hazard to patient

Answer:

Waived

Question:

_______ tests are:

- moderate-complexity tests
- represent a subcategory added at the request of providers

Answer:

PPMP

Question:

The following criteria are used to categorize ______ and _______ tests.

1. degree of operator intervention needed
2. necessary knowledge and experience
3. degree of maintenance and troubleshooting needed

Answer:

moderate- and high-complexity

Question:

What is the medical term for contagious?

Answer:

communicable

Question:

What is an immune system that does not protect from infection?

Answer:

suppressed immune system

Question:

- aka infection control
- consists of procedures and practices that healthcare profs. use to protect them from infection

Answer:

medical asepsis

Question:

Which agency investigates various diseases in an attempt to control them and makes recommendations on how to prevent the spread of disease?

Answer:

The Centers for Disease Control and Prevention (CDC)

Question:

Standard and Universal Precautions were who's guidelines?
a) OSHA
b) CDC
c) CLIA
d) POL

Answer:

b) CDC

Question:

CLIA comes under which aegis?
a) Centers for Medicare and Medicaid Services (CMS)
b) U.S. Department of Labor
c) MSDS

Answer:

a) (CMS)

Question:

Which agencies purpose is to:
safeguard the public by regulating all testing of specimens taken from the human body?

Answer:

CLIA

Question:

Which agencies purpose is to require employers to ensure employee safety regarding occupational exposure to potentially harmful disease?

Answer:

OSHA

Question:

CLIA regulations require that all laboratories in the U.S. and its territories meet performance requirements that are based on test _____ and risk factors associated w/ incorrect test results.

Answer:

complexity

Question:

CLIA regulations affect all aspects of the laboratory, specifying the type of test performed, personnel involved in testing, and _____.

Answer:

quality control

Question:

CLIA is _____, therefore, all costs of administering the program must be covered by the regulated facilities.

Answer:

user-free funded

Question:

Laboratories must first register (by completing an application, pay fees, be surveyed if applicable), and become certified - just to ______ in the CLIA program.

Answer:

enroll

Question:

CLIA _____ are based on the certificate requested by the lab and the annual volume and types of testing performed

Answer:

fees

Question:

All labortories are required to register w/ CLIA '88 even if jut one test is performed, regardless of whether there is Medicare and Medicaid ______ and regardless of which category the test is found in.

Answer:

reimbursement

Question:

- CMS form 116 for clinical laboratory application for _____
- form collects info regarding a lab's operation, and i needed to evaluate fees, determine baseline data, update existing data, and to fulfill legal requirements

Who must receive this application w/in 30 days of receipt?

Answer:

CLIA

Question:

All high-complexity tests must be done by technologists and technicians except for ______, which requires more stringent qualifications.

Answer:

cytology

Question:

-The intention of this law is to heighten employee awareness of risks linked with chemical dangers
- It serves to improve work practices through employee training and identification of hazardous cheemicals

Answer:

Occupational Exposure to Hazardous Chemicals in the Laboratory

Question:

Which one is sodium hypochlorite?
a) stain
b) reagent
c) household bleach

Answer:

c) household bleach

Question:

The 3 primary goals employers must accomplish to be in compliance with OSHA standard for chemical exposure:

Answer:

1) there must be an inventory and a list of all chemicals considered hazardous. Following info must be documented: - quantity of chemical stored per month/yr - gas, liquid, or solid - manufacturer's name and address - chemical hazard classification 2) a Material Safety Data Sheet (MSDS) has to be assembled - statements should be organized into a book 3) Provide a hazard communication edu program to employee w/in 30 days of employment - training prog should consist of the loc and id of hazardous chem, how to read and understand the labels, where the MSDS is kept, when to use PPE, procedures to follow for chem spills - training session must

Question:

The various chemicals are labeled using National Fire Protection Association's color and number method. How many colors are there?

Answer:

4

Question:

There are four colors, ea. signifying a warning to the person handling the chemical(s). They are:
- Blue signifies a health hazard
- Red signifies a flammability hazard
- Yellow signifies reactivity or instability hazard
- White signifies a special hazard and the use of personal protective equipment(PPE). How do the numbers work?

Answer:

The numbers 0-4 are used in conjunction with the colors to indicate the level of risk for each product and are assigned by the manufacturer using the rating system. (the numbers can be found on the MSMD)

Question:

What type of warning does BLUE signify?

Answer:

health hazard

Question:

What does RED signify?

Answer:

flammibility hazard

Question:

YELLOW signifies which type of warning?

Answer:

reactivity/instability hazard

Question:

Which hazard does white signify?

Answer:

a special hazard and the use of (PPE)

Question:

Which hazard does white signify?

Answer:

a special hazard and the use of (PPE)

Question:

BLUE: HEALTH HAZARD

Answer:

4= Danger: May be fatal 3= Warning: Corrosive or toxic 2= Warning: Harmful if inhaled 1= Caution: May cause irritation 0= No unusual hazard

Question:

RED: FLAMMABILITY

Answer:

4= Danger: Flammable gas/extremely flammable liquid 3= Warning: Flammable liquid 2= Caution: Combustible liquid 1= Caution: Combustible if heated 0= Noncombustible

Question:

YELLOW: REACTIVITY/INSTABILITY

Answer:

4= Danger: Explosive at room temp 3= Danger: May be explosive if spark occurs/if heated under confinement 2= Warning: Unstable/may react if mixed with water 1= Caution: May react if heated/mixed with water 0= Stable: Nonreactive when mixed with water

Question:

WHITE: SPECIAL HAZARD/PROTECTION

Answer:

A Goggles B Goggles, gloves C Googles, gloves, apron D Face shields, gloves, apron E Goggles, gloves, mask F Goggles, gloves, apron, mask X Gloves

Question:

Because students are not considered employees, do they still fall under OSHA guidelines?

Answer:

No.

Question:

Container (A) Distilled water:
BLUE: 0
RED: 0
WHITE: blank

Answer:

Presents no health, flammability, or reactivity/instability hazard and requires no PPE when used

Question:

Container (A) Distilled water:
BLUE: 0
RED: 0
WHITE: blank

Answer:

Presents no health, flammability, or reactivity/instability hazard and requires no PPE when used

Question:

What must be done if chemicals come in contact with skin?

Answer:

It must be flushed immediately with water and continued for 5 minutes

Question:

What should be done if chemicals get into an eye?

Answer:

Eye must be flushed for 15 minutes (unless contradicted on the label).

Question:

Toxic fumes can occur w/ certain chemicals and certain tests can cause lung irritation and damage. How should this type of chemical be handled?

Answer:

Under a fume hood that will take the fumes away by means of a ventilation mechanism.

Question:

SODIUM HYPOCHLORITE:
RED: 0
BLUE: 2
YELLOW: 1

Answer:

Does not promote a flammability hazard (red is zero) Harmful if inhaled (blue is 2) may react or become unstable if heated or mixed with water (yellow is a 1).

Question:

What new threat has OSHA been focusing its attention on?

Answer:

Ergonomic hazards

Question:

What is ergonomics?

Answer:

the study of the workplace

Question:

OSHA published its first standard, Ergonomic Hazards, in 1991. At the heart of these guidelines is the prevention of what?

Answer:

cumulative trauma disorders

Question:

What are cumulative trauma disorders?

Answer:

Injuries involving the musculoskeletal or nervous system, such as carpal tunnel syndrome and trigger finger.

Question:

What are the result of:
- long-term, repetitive work actions
- gripping
- keyboard use
- pipetting
- microscopy

Answer:

cumulative trauma disorders

Question:

The core for the OSHA safety standard for chemical exposure is:
a. the dipstick test
b. the chemical hygiene plan
c. the quantity of chemical stored per month
d. the MSDS manual

Answer:

the chemical hygiene plan

Question:

Standard Precautions were issued by?
a. DHHS
b. CDC
c. CMS
d. OSHA

Answer:

CDC

Question:

CLIA '88 was made law to reulate:
a. the disposal of infectious diseases
b. the use of chemicals in the workplace
c. laboratory tests performed on specimens taken from the human body
d. the transmission of the human immunodeficiency virus (HIV)

Answer:

laboratory tests performed on specimens taken from the human body

Question:

When an accident occurs, a blood sample is collected and _________.

Answer:

analyzed/tested for alcohol/drugs

Question:

When an accident occurs, a blood sample is collected and _________.

Answer:

analyzed/tested for alcohol/drugs

Question:

These tests are sometimes a part of the data gathered for research and for clinical trials information.

Answer:

laboratory tests

Question:

What is the medical term used that means - exhibits no symptoms associated with a disease process- but discover a disorder in an unrelated area during routine screening or testing?

Answer:

asymptomatic

Question:

When a patient reports specific symptoms and describes a particular condition, this is ________ information.

Answer:

subjective

What are the three categories of testing under CLIA quizlet?

Which of the following organization is responsible for test categorization and CLIA studies?

How many CLIA categories are there?

Which of the following is an example of a CLIA waived test ____?