LICENSING

Question 1

Government rules and regulations include the following: (LOR)

Answer 1

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

Question 2

OSHA meaning

Answer 2

Occupational Safety and Health Administration

Question 3

2 Federal Regulation of Medical Laboratories

Answer 3

1. Licensure of Laboratories
2. Licensure of Personnel

Question 4

Permission to engage in business activity

Answer 4

Licensure of Laboratories

Question 5

Permission to practice an occupation/profession

Answer 5

Licensure of Personnel

Question 6

Medicare Legislation an amendment to the social security act

Answer 6

1965

Question 7

First edition of CLIA became law

Answer 7

1967

Question 8

CLIA meaning

Answer 8

Clinical Laboratories Improvement Amendment

Question 9

CLIA was revised

Answer 9

1988

Question 10

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

Answer 10

CLIA’88

Question 11

Highlights of CLIA’88 (CSRB)

Answer 11

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

Question 12

Classifies laboratories based on the complexity (LMHP)

Answer 12

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

Question 13

Set personnel qualifications for six groups (DTTCGT)

Answer 13

Diretor
Technical consultant
Technical supervisor
Clinical consultant
General supervisor
Testing personnel

Question 14

Baccalaurate laboratories can perform at four levels

Answer 14

Director
Technical consultan
General/Technical supervisor
Testing personnel

Question 15

Waived tests, considered to have low-complexity testing methodology

Answer 15

Category l

Question 16

Moderate complexity testing methodology

Answer 16

Category ll

Question 17

High complexity testing methodology

Answer 17

Category lll

Question 18

Provider Perfomed Microscopy Procedure (PPMP)

Answer 18

Category lV

Question 19

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

Answer 19

Department of Health and Human Resources

Question 20

The 7 criteria of DHHR (LTCOCED)

Answer 20

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

Question 21

2 Qualifiers of Moderate-Complexity category

Answer 21

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

Question 22

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

Answer 22

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

Question 23

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

Answer 23

Ceritificate of waiver or registration

Question 24

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

Answer 24

Quality control and quality assurance

Question 25

Protects the integrity of specimen and the reporting of accurate results

Answer 25

Patience test management

Question 26

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

Answer 26

Processing and receiving service requisition

Question 27

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

Answer 27

Inspection

Question 28

Laboratory Inspection and Accreditation Programs (JCAC)

Answer 28

1. JCAHO 2. CAP 3. AABB 4. COLA

Question 29

JCAHO

Answer 29

Joint Commission on the Accreditation and Healthcare Organizations

Question 30

CAP

Answer 30

College of American Pathologists

Question 31

AABB

Answer 31

American Associate of Blood Bank

Question 32

COLA

Answer 32

Commission on Office Laboratory Accreditation

Question 33

Professional Certification of Laboratory Personnel (AANP)

Answer 33

1. AMT 2. ASCP 3. NCAASCLS 4. PRC

Question 34

AMT

Answer 34

American Medical Technologist

Question 35

ASCP

Answer 35

American Society for Clinical Pathologist

Question 36

NCAASCLS

Answer 36

National Certifying Agency of the American Society of Clinical Laboratory Science

Question 37

PRC

Answer 37

Professional Regulation Commision

Question 38

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

Answer 38

the Secretary of Health or Department of Health (DOH)

Question 39

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

Answer 39

Administrative Order No. 201 Series 1973

Question 40

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

Answer 40

100 pesos

Question 41

how much is the renewal fee

Answer 41

50 pesos

Question 42

renewal fee must be paid within

Answer 42

last 2 months of each year

Question 43

grace period of renewal of license

Answer 43

2 monts

Question 44

fine per month

Answer 44

10 pesos

Question 45

___ laboratories are exempted from these fees

Answer 45

government laboratories

Question 46

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

Answer 46

15 days

Question 47

Required Personnel (HAPMLL)

Answer 47

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