UNIVERSITY OF NEBRASKA MEDICAL CENTER SCHOOL OF ALLIED HEALTH PROFESSIONS ...

165 Pages·2009·1.6 MB·English

UNIVERSITY OF NEBRASKA MEDICAL CENTER
SCHOOL OF ALLIED HEALTH PROFESSIONS
CLINICAL LABORATORY SCIENCE PROGRAM

Course Title: Clinical Laboratory Practicum for the Nurse Practitioner

Course Number: CLS 550

Prerequisites: Enrollment in the Graduate Nursing Program

Semesters offered: Semester I & II

Instruction: Instructional methods will include lectures, small group discussions, case
studies, exercises, and laboratory experience.
Course Description: This course includes the theory, practical application, technical
performance and evaluation of selected procedures used in the analysis of
blood, urine and selected body fluids.

Course Goals: Upon successful completion of Clinical Laboratory Practicum, the Nurse
Practitioner student will:

1. Demonstrate a working knowledge of the theory and techniques used in
standard laboratory procedures for the analysis of urine and designated
body fluids.

2. Effectively perform procedures included in the Provider Performed
Microscopy Category.

3. Demonstrate the ability to properly operate a brightfield microscope.

4. Choose selected laboratory procedures that will effectively provide
quality patient care.

5. Perform selected laboratory procedures with accuracy and efficiency to
provide quality patient care.

6. Evaluate test results by including pre-analytical, analytical, post-
analytical test conditions together with QC results.

7. Correlate test results with normal and abnormal physiologic conditions.

Course Faculty: Roxanne Alter [phone]
Darlene Waters [phone]
Linda Fell [phone]
Linsey Donner [phone]
Nicole Zacher [phone]
Clinical Laboratory Science Program
Clinical Laboratory Practicum
For Nurse Practitioner Students
OBJECTIVES:
Upon completion of the lectures, cases, and practice exercises the Nurse Practitioner student
will be able to:

1. Describe Clinical laboratory safety regulations.

2. Utilize resources explaining appropriate specimen collection, handling and processing
(i.e. pre-analytical) concerns for each of the following:
a. urinalysis
b. bacterial cultures
c. cell count (blood and other body fluids)
d. molecular diagnostic methods
e. direct examination

3. Utilize resources for troubleshooting and preventing erroneous test results.

4. Correlate laboratory findings with normal and abnormal physiologic conditions,
including clinical presentation and pathophysiology for urinalysis tests and other tests
described in this practicum.

OBJECTIVES:

Upon completion of the student laboratories the Nurse Practitioner student will be able to:

1. Practice clinical laboratory safety regulations.

2. Perform testing using common procedures utilized in the clinical setting.

3. Perform quality control for common laboratory tests in the clinical setting.

4. Record patient test and quality control results in the appropriate log chart.

5. Evaluate quality control results to detect values that fall outside acceptable limits or that
fail to exhibit appropriate positive or negative results, taking corrective action.

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DAY 1 Schedule for Nurse Practitioner Practicum

8:00 Welcome and Introductions

8:15 CLIA Regulations Overview

9:15 Quality Control Overview

9:45 Break

10:00 Microscopy

10:15 Microscopic Examination of the Urine

11:30 LAB#1

12:30 Lunch

1:15 Chemical Analysis of the Urine

2:15 LAB#2

3:30 Analysis of Vaginal Secretions

4:30 LAB#3

5:00 Dismissal

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DAY 2 Schedule for Nurse Practitioner Practicum

8:00 Microscopic Slide Examination and Review/ Microscopic Cases #1-#8

9:30 LAB#4

11:00 Hematology

12:00 LAB#5

12:45 Lunch

1:30 Point of Care Testing

2:00 LAB#6

3:00 Molecular Testing

3:25 Drug Screening

3:45 LAB#7

4:00 Specimen Collection Review and Wrap-Up

4:30 Dismiss

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GUIDELINES FOR SAFETY IN THE LABORATORY

1. Assume that all blood and body fluids have the potential of carrying infectious disease.
Follow standard precautions including hand washing and PPE.

2. NO drinking (pop cans or any other open containers cannot be brought into the lab),
eating or smoking are permitted in the laboratory.

3. Appropriate dress is required in the lab per OSHA regulations. At all times legs must be
covered and no open toe or sandal type shoes are allowed.

4. Lab coats or isolation gowns must be worn during laboratory time. If the coat is soiled a
new one must be used.

5. Gloves are to be worn when working with blood and body fluids. Change often and
when necessary.

6. Remove gloves when touching an area considered to be clean or when leaving lab area.
Wash hands thoroughly when leaving the lab area.

7. Place all sharp objects (slides, needles) in plastic containers provided. Place all
contaminated waste material in correct biohazard containers. Do NOT put tissues in the
sharps containers.

8. Gauze should be used for opening vacutainer blood tubes (first time). Open in manner
that cap is popped away from the face.

9. Decontaminate lab counters at the end of the lab and /or whenever a spill occurs. Be
familiar with location of the MSDS manual and notify your instructor of any accident
immediately.

10. If you are careful and use common sense, no problems should arise if the proper
precautions are followed.

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CLINICAL LABORATORY IMPROVEMENT AMENDMENT

Objectives: Upon completion of this lecture the Nurse Practitioner student will be able to:

1. Discuss the Clinical Laboratory Improvement Amendment (CLIA) of 1988.

2. Discuss the role CLIA in the regulation and certification of laboratories.

3. Analyze the impact that CLIA has had on the regulation of the Clinical Laboratory.

4. Compare the Provider Performed Microscopy classification to the three other complexity
classifications in CLIA.

5. Evaluate a laboratory’s compliance with the CLIA regulations.

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I. Summary of Clinical Laboratory Improvement Amendment
A. Mandated licensure of laboratories (facility as opposed to personnel licensure).
1. Under CLIA all laboratories must meet standards based on the complexity
of the tests that they perform.
2. Laboratories performing moderate or high complexity testing must meet
the requirements for proficiency testing, patient test management, quality
control, quality assurance, and personnel.

B. Facility Licensure
1. Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
2. College of American Pathologists (CAP)
3. Clinical Laboratory Improvement Act of 1988 (CLIA’88)

C. Complexity Model
1. Waived – waived testing is determined by FDA or CDC to be so simple that there
is little risk of error.
2. Provider Performed Microscopy
3. Moderately Complex
4. Highly Complex

D. Regulatory Differences between Waived and Non-waived (Moderately and Highly
complex) testing
1. Quality Control
2. Personnel standards

E. Provider-Performed Microscopy
1. New category included certain procedures that can be performed in
conjunction with any waived test.
2. The tests within this new category are exempt from routine inspection but
personnel standards are more stringent.
3. Laboratories must meet moderate-complexity requirements for proficiency
testing, patient test management, QC&QA.
F. Quality Assurance
1. Process implemented to ensure that every action taken by the laboratory
contributes to quality patient care

2. Documentation used to evaluate the entire testing process from test
ordering and specimen collection through reporting and interpreting of
results. It includes:
a. Procedure manuals which include specimen collection and testing
b. Internal Quality Control
c. Proficiency Testing
d. Record keeping
e. Equipment maintenance
f. Safety Program
g. Training and Continuing Education
h. Written policies
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II. Clinical Laboratory Improvement Amendment

A. History
1. Enacted as a result of reports of inaccurate test results from Pap smears
2. Facility certification as opposed to personnel licensure

B. CLIA’s purpose
1. Comprehensive plan to improve the quality of all laboratories and lab testing
2. 1987: there were 12,000 out 200,000 labs regulated
3. 2002: there were 170,000 regulated labs

C. CLIA Standards
1. Based on complexity of testing (such as dilutions or calculations), not on
laboratory site
2. How complex is it for the CLS person to run the test; e.g. training, knowledge,
and interpretation.

D. Waived Category Tests
1. 9 generic tests
2. Categorized by regulation
3. Automatically waived
4. Still require review and notification from FDA
5. Require posting categorization on website

E. Generic 9
1. Dipstick and tablet reagent urinalysis
2. Fecal occult blood
3. Ovulation tests
4. Urine pregnancy tests
5. Erythrocyte sedimentation rate
6. Hemoglobin (copper sulfate)
7. Blood glucose devices
8. Spun microhematocrits
9. Hgb devices (Hemocue first instrument waived)

F. Waived Testing Requirements
1. Test systems are simple laboratory examinations and procedures
2. Cleared by FDA for home use
3. Employ methodologies that are so simple and accurate as to render the likelihood
of erroneous results negligible
4. Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
GG.. MMoost Common Waived Tests
1. Urine pregnancy – 34%
2. Blood glucose (OTC) – 18%
3. Urine dipstick/ tablet chemistries – 19%
4. Ovulation tests – 5%
5. Fecal occult blood – 4%
6. All other tests – 20%
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H. Over the Counter Testing
1. Growing number of OTC test
2. Drugs of abuse
3. Cholesterol
4. Vaginal pH
5. Microalbumin
6. Follicle stimulating hormone
III Categorization
A. Categorization
1. Process of assigning new commercially marketed tests to one of 3 CLIA
categories: waived, moderate, high
2. The key to understanding categorization: the analyst/operator and the complexity
of the test.

3. Categorization applies to all laboratory test systems on materials derived from the
human body conducted for the purpose of diagnosis, prevention or treatment, or
assessment of health.
4. Commercially marketed tests which produce a result

B. Examples of items not categorized
1. Produces no test result
2. Quality control, calibrators
3. Collection kits such as drugs of abuse and hepatitis C

C. FDA’s CLIA website
1. http://www.fda.gov/cdrh/ovid/clia.html
2. http://www.fda/gov/cdrh/clia
3. “Government Google”
4. Lists all waived analytes and tests
5. Links to CMS, CDC websites
6. CLIA database
E. Search CLIA Database
1. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/analytieswaived.cfm
2. Contains all commercially marketed tests categorized by CDC and FDA
3. Several ways to search
4. Searching the CLIA database
a. Test system name
b. Specialty
c. Analyte
d. Document number
e. Qualifier
f. Complexity
g. Enter first word
h. Or first few letters
i. First few letters of the manufacturer

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Case #1
As the owner of a family practice clinic and the Nurse Practitioner in charge, you have
decided that you would like to offer your patients point of care testing. The tests that will
be offered are hemoglobin, Rapid Strep and glucose testing. Describe the quality control,
personnel requirements and other protocols necessary to meet the CLIA regulations.

Case #2
As the Nurse Practitioner in charge you have decided that you would like to offer an
automated CBC to your testing menu. As the CLIA expert what implementation changes
need to be incorporated to meet the required CLIA regulations.

Case #3
Under CLIA, automated procedures that do not require operator intervention during the
analytic process are classified as: waived, moderate, highly complex or provider
performed microscopy.

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