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HCLD ABB Gen Know (passed) > CLIA and OSHA > Flashcards

CLIA and OSHA Flashcards

1
Q

Labs that are exempt from CLIA *

A

Forensic labs, research labs, drug testing labs (NIDA)

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2
Q

CMS Definition: *

A

Centers for Medicare and Medicaid Services

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3
Q

CMS applies to: *

A

Laboratories billing medicare and medicaid

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4
Q

Certificate of registration *

A

Lab’s that are just starting out will get this until they are inspected.

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5
Q

Certificate of compliance *

A

Required for labs performing moderate of high complexity testing. Given by STATE CMS inspectors after the lab has met requirements for certification.

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6
Q

Certificate of accreditation *

A

Issued to labs that meet the standards of a private non-profit accreditation program approved by CMS. Issued in lieu of other certificates.

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7
Q

Accreditation agency must be More or Less strict than CLIA*

A

More

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8
Q

If the lab changes ownership, name, location, director or technical supervisor, they must notify CMS within: *

A

30 days

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9
Q

If the lab adds, subtracts, or changes test menu, they must notify CMS within: *

A

6 months

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10
Q

Provider performed microscopy *

A

Are subject to their own certification, considered moderately complex, are subject to inspection. Must be done in the office on live specimens.

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11
Q

Unsatisfactory PT

A

Failure to attain a passing score in one testing event, requires corrective action.

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12
Q

Unsuccessful PT

A

Unsatisfactory performance in two consecutive or two out of three testing events.

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13
Q

Successful Participation in PT

A

Satisfactory performance is considered 80%

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14
Q

Quality Systems required for non-waived testing. List 7 *

A
  1. Confidentiality of PHI
  2. Competency of personnel and review corrective action.
  3. Complaint investigations and documentation.
  4. Communication between lab and physicians, document
  5. Specimen Identification and integrity
  6. Evaluate PT performance
  7. General Lab Systems Assessment, document review
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15
Q

Technical Supervisor (high complexity) must evaluate competency how often? *

A

On hire (after training), again in 6 months, and annually after that, unless methodology changes.

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16
Q

The Test Requisition must include what 5 components: **

A
  1. Patient name or other identifier
  2. Sex and age or DOB
  3. Name and address of requestor/ contact
  4. The test to be performed
  5. The date and time of collection
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17
Q

Pap samples must also include: *

A

Date of last menstrual period and whether the patient has had previous abnormal results.

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18
Q

Oral requests for tests are permitted only if: *

A

The laboratory requests written authorization within 30 days

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19
Q

How long do you have to save test requisition *

A

2 years

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20
Q

How long do you have to save QC records *

A

2 years or 5 years for immunohematology

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21
Q

How long do you have to save test records and test reports *

A

2 years or
5 years for immunohematology and cytology slides
10 years for pathology records

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22
Q

Test records must include: *

A
  1. ID of tech performing test
  2. ID of patient
  3. Date and time of specimen receipt
  4. Condition of specimen
  5. Date and time of testing
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23
Q

The test report must include: *****

A
  1. Patient’s name or ID number
  2. Name and address of the lab
  3. Report date
  4. Test performed
  5. Specimen source
  6. Result, units, and interpretation
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24
Q

True or False: CLIA labs that are also HIPPA covered entities must provide the patient with a copy of their test report within 30 days of their request? *

A

True

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25
Q

Reagent label must include: *****

A
  1. Identity
  2. Concentration
  3. Storage Requirements
  4. Date made and expiration
  5. Lot number
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26
Q

PPM Personnel Requirements

A
  1. Director
  2. Testing personnel
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27
Q

Moderate Complexity Personnel Requirements

A
  1. Director
  2. Technical Consultant
  3. Clinical Consultant
  4. Testing personnel
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28
Q

Requirements to be a moderate complexity lab director: *

A
  1. Pathologist
  2. Physician with experience
  3. Ph.D with certification and experience
  4. M.S. or B.S. with experience
29
Q

High Complexity Personnel Requirements*

A
  1. Director
  2. Technical Supervisor
  3. Clinical Consultant
  4. General Supervisor
  5. Testing personnel
30
Q

Requirements to be a High Complexity Director: *

A
  1. Pathologist
  2. Physician with experience
  3. Ph.D with certification and experience
31
Q

OSHA requires that clinical laboratories should have these three separate, but coordinated plans.

A
  1. Bloodborne Pathogen Plan
  2. Hazard Communication Plan
  3. Chemical Hygiene Plan
32
Q

As part of the Bloodborne Pathogens Plan labs must appoint

A

Appoint a safety officer to train employees to protect themselves

33
Q

Exposure control plan must describe:

A

Must describe potential risks in the laboratory, measures taken to protect employees, and procedures to follow if exposed to bloodborne pathogens.

34
Q

Required engineering controls

A

Sinks for hand washing, sharps containers, red bags for waste, leak proof containers for blood storage, shields, and safety cabinets.

35
Q

Examples of BSL-1 bugs *

A

E. coli and other nonpathogenic

36
Q

Examples of BSL-2 bugs *

A

Staph, HBV, HIV, post biohazard warnings

37
Q

Examples of BSL-3 bugs *

A

Tuberculosis, anthrax, must decontaminate waste and clothing

38
Q

Examples of BSL-4 bugs *

A

Ebola, Marburg, clothing change before entering and shower on exit.

39
Q

OSHA requires that employee exposure medical records be kept for: *

A

The term of employment plus 30 years

40
Q

If the entity cannot afford to store employee exposure medical records:*

A

Notify employees and give them one year to pick them up
Pay a company to scan and store them electronically.
Destroy them.

41
Q

OSHA requires that bloodborne pathogen records be kept for: *

A

Three years

42
Q

The Hazard Communication Plan *

A
  1. ensure proper labelling of hazardous chemicals
  2. maintain safety data sheets that are accessible
  3. Ensure personnel are aware of hazards, training
43
Q

The Hazard Communication Plan *

A
  1. ensure proper labelling of hazardous chemicals
  2. maintain safety data sheets that are accessible
  3. Ensure personnel are aware of hazards, training
44
Q

Hazard determinations must evaluate

A

a chemical’s carcinogenicity

45
Q

What are the seven classes of hazardous substances?

A
  1. Carcinogen or health hazard
  2. Corrosive
  3. Explosive
  4. Flammable
  5. Irritant
  6. Sensitizer
  7. Toxic
46
Q

Hazardous chemical labeling requirements *

A

Name, address, and phone number of manufacturer, chemical name and batch, Signal word, Hazard statements, precautionary statement, pictograms, and supplementals.

47
Q

Flame over circle *

48
Q

Exclamation mark *

A

Irritant, sensitizer, toxic

49
Q

Skull and crossbones *

A

Acute toxicity

50
Q

Chemical Hygiene Plan (CHP) *

A

Lists procedures, equipment, PPE, and work practices that protect employees from hazardous chemical exposure in the workplace.

51
Q

The Environmental Protection Agency (EPA) and the Department of Transportation (DoT) require what documentation for hazardous waste transport?

A

A uniform hazardous waste manifest

52
Q

The atmospheric oxygen must be in what range? *

A

19.5 - 23.5% Important if liquid Nitrogen is used.

53
Q

Symptoms if oxygen is 16-19.5%? *

A

Symptomatic

54
Q

Symptoms if oxygen is 12-16%? *

A

Tachycardia, Impaired attention and coordination

55
Q

Symptoms if oxygen is 10-14%? *

A

Impaired judgement, intermittent respiration, exhaustion

56
Q

Symptoms if oxygen is 6-10%? *

A

Nausea, Vomiting, lethargic movements, unconsciousness

57
Q

Symptoms if oxygen is <6%? *

A

Convulsions, apnea, cardiac standstill

58
Q

A Class A fire extinguisher is used for what types of fires? *

A

paper, wood, cloth, (green triangle)

59
Q

A Class B fire extinguisher is used for what types of fires? *

A

flammable liquids, ethanol, acetone, xylene, methanol (red square)

60
Q

A Class C fire extinguisher is used for what types of fires? *

A

electrical equipment, analyzers, wiring, circuit breakers, and outlets (blue circle)

61
Q

A Class D fire extinguisher is used for what types of fires? *

A

combustible metals, magnesium, sodium, lithium, and potassium (yellow decagon)

62
Q

Carbon dioxide fire extinguishers are used for *

A

Class B and C fires, leaves no residue, so good for laboratories with expensive electronics. Not good for outdoor, cold or windy situations.

63
Q

Bromochlorodifluoromethane (Halon 1211) fire extinguishers are used for *

A

Class A, B and C fires, leaves no residue, so good for laboratories with expensive electronics. These have been phased out because they destroy ozone.

64
Q

Bromochlorodifluoromethane (Halon 1211) fire extinguishers are used for *

A

Class A, B and C fires, leaves no residue, so good for laboratories with expensive electronics. These have been phased out because they destroy ozone.

65
Q

Fire Plan R A C E

A

Remove anyone from danger
Activate fire alarm
Confine fire by closing doors
Extinguish fire or evacuate area

66
Q

Fire extinguisher operation P A S S

A

Pull the pin
Aim hose at base of fire
Squeeze handle
Sweep side to side

67
Q

ALARA for radiation safety

A

As low as reasonably achievable

68
Q

As part of OSHA Noise Exposure and hearing conservation program, employers must provide PPE, hearing protectors if the noise level is above what? *

A

> 85 dBA over an 8 hour period

69
Q

If noise is >85dBA, the employer must develop

A

A monitoring program to monitor noise levels

HCLD ABB Gen Know (passed) (6 decks)

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