Chapter 2: Regulations Governing Laboratory Personnel

Multiple Choice
Identify the choice that best completes the statement or answers the question.

____	1.	A medical assistant may perform:
A.	Clinical chemistry tests of high complexity	
B.	Cytology examinations identifying abnormal cells	
C.	CLIA-waived testing procedures	
D.	Identification of microorganisms by observation of growth patterns	

____	2.	Which of these abbreviations does not represent an agency involved in CLIA ’88 compliance or regulations?
A.	CMS	
B.	FDA	
C.	PPMP	
D.	HHS	

____	3.	A standardized formal assessment process that measures the quality of test results describes:
A.	Provider-performed microscopy procedures	
B.	Testing of moderate complexity	
C.	Testing of high complexity	
D.	Proficiency testing	

____	4.	Which of these laboratory professionals could serve as a laboratory director of a hospital laboratory?
A.	Medical laboratory technician	
B.	Board-certified pathologist	
C.	Registered nurse	
D.	Nationally certified phlebotomist	

____	5.	Formal recognition of competence achieved by an examination is a:
A.	Credential	
B.	Classification	
C.	Title	
D.	Degree	

Multiple Response
Identify one or more choices that best complete the statement or answer the question.

For the following health-care professionals, please document their potential places of employment in a laboratory.  (Select all answers that apply.)

____	6.	Medical Assistant

A.	Physician office laboratory	
B.	Hospital	
C.	Reference laboratory	

____	7.	Nurse practitioner

A.	Physician office laboratory	
B.	Hospital	
C.	Reference laboratory	

____	8.	Pathologist

A.	Physician office laboratory	
B.	Hospital	
C.	Reference laboratory	

____	9.	Medical laboratory technician

A.	Physician office laboratory	
B.	Hospital	
C.	Reference laboratory	

____	10.	Medical laboratory scientist

A.	Physician office laboratory	
B.	Hospital	
C.	Reference laboratory	

____	11.	Phlebotomist

A.	Physician office laboratory	
B.	Hospital	
C.	Reference laboratory	

True/False
Indicate whether the statement is true or false.

____	12.	CLIA ‘88 was developed to ensure better working conditions for laboratory employees.

Short Answer

	13.	What health-care professional is often in charge of a laboratory?

	14.	Lily Black is a new graduate from the local medical assisting program. She is hired by a local laboratory to support the staff in the lab and perform some laboratory testing. Will Lily be able to perform tests that have been designated as high-complexity procedures?

Chapter 2: Regulations Governing Laboratory Personnel
Answer Section

MULTIPLE CHOICE

	1.	ANS:	C
Although medical assistants may perform more than CLIA-waived test procedures with additional training and appropriate documentation, the other choices listed in this question are not things that an MA could perform even with this additional training.

PTS:	1	KEY:	Blooms: Remembering | Outcome: 2-5	

	2.	ANS:	C
CMS is the Center for Medicare and Medicaid Services, FDA is the Food and Drug Administration, and HHS is the United States Department of Health and Human Services. These agencies are all involved in CLIA ’88 compliance. PPMP stands for provider-performed microscopy procedures; this is not an agency.

PTS:	1	KEY:	Blooms: Remembering | Outcome: 2-9	

	3.	ANS:	D
Proficiency testing is a formal assessment method that compares the test results from laboratories against one another, measuring the quality of the test results obtained by the laboratories.

PTS:	1	KEY:	Blooms: Remembering | Outcome: 2-1	

	4.	ANS:	B
Regulations specify who may be a laboratory director; of these choices, only the board-certified pathologist qualifies to lead a hospital laboratory.

PTS:	1	KEY:	Blooms: Evaluating | Outcome: 2-3		

	5.	ANS:	A
Credentials are obtained by successfully passing an examination.

PTS:	1	KEY:	Blooms: Remembering | Outcome: 2-1	

MULTIPLE RESPONSE

	6.	ANS:	A, B, C
Health-care professionals may be present in various settings, and some specialties may be employed in more than one environment.

PTS:	1	KEY:	Blooms: Applying | Outcome: 2-2

	7.	ANS:	A
Health-care professionals may be present in various settings, and some specialties may be employed in more than one environment.

PTS:	1	KEY:	Blooms: Applying | Outcome: 2-2

	8.	ANS:	B, C
Health-care professionals may be present in various settings, and some specialties may be employed in more than one environment.

PTS:	1	KEY:	Blooms: Applying | Outcome: 2-2

	9.	ANS:	A, B, C
Health-care professionals may be present in various settings, and some specialties may be employed in more than one environment.

PTS:	1	KEY:	Blooms: Applying | Outcome: 2-2

	10.	ANS:	A, B, C
Health-care professionals may be present in various settings, and some specialties may be employed in more than one environment.

PTS:	1	KEY:	Blooms: Applying | Outcome: 2-2

	11.	ANS:	A, B
Health-care professionals may be present in various settings, and some specialties may be employed in more than one environment.

PTS:	1	KEY:	Blooms: Applying | Outcome: 2-2

TRUE/FALSE

	12.	ANS:	F
CLIA ‘88 was actually developed to protect patients. Prior to the development of this policy, laboratory testing had very little regulation, and many tests were performed by poorly trained or unqualified personnel.

PTS:	1	KEY:	Blooms: Understanding | Outcome: 2-6	

SHORT ANSWER

	13.	ANS:	
Pathologist
Rationale: Regulations specify which health-care personnel may be laboratory directors. Pathologists are the most common professionals in this role.

PTS:	1	KEY:	Blooms: Remembering | Outcome: 2-2	

	14.	ANS:	
No, Lily does not possess the education or training to perform high-complexity procedures.
Rationale: The CLIA ’88 regulations specify who can perform laboratory testing at which levels of complexity.

PTS:	1	KEY:	Blooms: Applying | Outcome: 2-8