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LAB MAN > LICENSING > Flashcards

LICENSING Flashcards

1
Q

Government rules and regulations include the following: (LOR)

A
  1. Labor relations
  2. OSHA (Occupational Safety and Health Administration)
  3. Rules affecting the general conduct of business
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2
Q

OSHA meaning

A

Occupational Safety and Health Administration

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3
Q

2 Federal Regulation of Medical Laboratories

A
  1. Licensure of Laboratories
  2. Licensure of Personnel
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4
Q

Permission to engage in business activity

A

Licensure of Laboratories

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5
Q

Permission to practice an occupation/profession

A

Licensure of Personnel

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6
Q

Medicare Legislation an amendment to the social security act

A

1965

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7
Q

First edition of CLIA became law

A

1967

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8
Q

CLIA meaning

A

Clinical Laboratories Improvement Amendment

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9
Q

CLIA was revised

A

1988

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10
Q

classifies and regulates laboratories based on the complexity if procedures being performed rather than on location

A

CLIA’88

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11
Q

Highlights of CLIA’88 (CSRB)

A
  1. Classifies laboratories based on the complexity of procedures being performed
  2. Set personnel qualifications for six groups
  3. Rules apply to all testing sites
  4. Baccalaurate laboratories can perform at four levels
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12
Q

Classifies laboratories based on the complexity (LMHP)

A
  1. Low complexity testing
  2. Moderate complexity testing
  3. High complexity
  4. Provider performed microscopy procedure
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13
Q

Set personnel qualifications for six groups (DTTCGT)

A

Diretor
Technical consultant
Technical supervisor
Clinical consultant
General supervisor
Testing personnel

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14
Q

Baccalaurate laboratories can perform at four levels

A

Director
Technical consultan
General/Technical supervisor
Testing personnel

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15
Q

Waived tests, considered to have low-complexity testing methodology

A

Category l

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16
Q

Moderate complexity testing methodology

A

Category ll

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17
Q

High complexity testing methodology

A

Category lll

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18
Q

Provider Perfomed Microscopy Procedure (PPMP)

A

Category lV

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19
Q

Uses 7 criteria to differentiate tests that maybe performed by moderate/high complexity laboratories

A

Department of Health and Human Resources

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20
Q

The 7 criteria of DHHR (LTCOCED)

A
  1. Level of knowledge needed
  2. Training and experience required
  3. Complexity of the preparation or reagents and material
  4. Operational steps required in the procedures
  5. Characteristics and availability of calibration, quality control and proficiency testing material
  6. Extent of troubleshooting and maintenance required
  7. Degree of interpretation and judgement necessary in the testing process
21
Q

2 Qualifiers of Moderate-Complexity category

A
  1. Automated procedures that do not require operator intervention
  2. Manual procedures with limited steps and limited samplw
22
Q

5 practice standards for moderate and high complexity laboratories requirements (CQPIP)

A
  1. Certification of waiver or registration
  2. Quality control and quality assurance
  3. Patient test management
  4. Inspection
  5. Personnel qualification
23
Q

Laboratories are initially require to obtain a certificate from the health care financing administration

A

Ceritificate of waiver or registration

24
Q

Standards are similar to those established by the practice parameters of professional laboratorian

A

Quality control and quality assurance

25
Q

Protects the integrity of specimen and the reporting of accurate results

A

Patience test management

26
Q

Patient test management provides regulations regarding the following aspects of practice (PSHI)

A

Processing and receiving service requisition

27
Q

Requires both records and facilities of certified laboratories be available unannounced inspection to check for compliance with its rule

A

Inspection

28
Q

Laboratory Inspection and Accreditation Programs (JCAC)

A
  1. JCAHO
  2. CAP
  3. AABB
  4. COLA
29
Q

JCAHO

A

Joint Commission on the Accreditation and Healthcare Organizations

30
Q

CAP

A

College of American Pathologists

31
Q

AABB

A

American Associate of Blood Bank

32
Q

COLA

A

Commission on Office Laboratory Accreditation

33
Q

Professional Certification of Laboratory Personnel (AANP)

A
  1. AMT
  2. ASCP
  3. NCAASCLS
  4. PRC
34
Q

AMT

A

American Medical Technologist

35
Q

ASCP

A

American Society for Clinical Pathologist

36
Q

NCAASCLS

A

National Certifying Agency of the American Society of Clinical Laboratory Science

37
Q

PRC

A

Professional Regulation Commision

38
Q

Any person, firm or corporation operating a clinical lab shall secure a license annually at the office of ?

A

the Secretary of Health or Department of Health (DOH)

39
Q

Revised rules and regulations governing the registration, operation and maintenance of clinical lab in the PH

A

Administrative Order No. 201 Series 1973

40
Q

a fee of ___ is to be paid to the Bureau of Research Lab for every license issued

A

100 pesos

41
Q

how much is the renewal fee

A

50 pesos

42
Q

renewal fee must be paid within

A

last 2 months of each year

43
Q

grace period of renewal of license

A

2 monts

44
Q

fine per month

A

10 pesos

45
Q

___ laboratories are exempted from these fees

A

government laboratories

46
Q

if a clinical lab manager will transfer his registered lab to another place, they should inform in writing the BRL within ___ after transfer

A

15 days

47
Q

Required Personnel (HAPMLL)

A
  1. Head of Laboratory Pathologist
  2. Associate Pathologist
  3. Pathology Assistant
  4. Medical Technologist
  5. Medical Technicians
  6. Laboratory Aids
48
Q
A

LAB MAN (8 decks)

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