Objectives

The participant will be able to:

Content

Reading Assignment

• Identify licensees who may now interpret clinical laboratory test results.
• Specify clinical laboratory personnel, including the newest addition to the list, who may consult in the areas of infection control and epidemiology and administer intradermal skin tests and vaccines.
• Define “direct supervision.”

Scope of practice of licensure             

Pp 1-11

• Distinguish between responsibilities that a laboratory director may or may not delegate to licensed supervisors.
• Specify how frequently supervisors must evaluate and document the performance of personnel doing testing.
• Identify the requirement that applies when a supervisor delegates a task to a licensed technologist.
• Distinguish between responsibilities of licensed technologists and licensed technicians.

Responsibilities of clinical laboratory personnel

• Specify notifications that must be provided to the Board of Clinical Laboratory Personnel.

Notifications

• Define negligence.

Violation of rules

Objectives

The participant will be able to:

Content

Reading Assignment

• Identify how to satisfy the Board rule that licensees earn one contact hour on the laws and rules of the Board each renewal cycle.
• Specify how to surrender licensure in a category.
• Identify the number of days within which continuing education providers must report course completions to CE Broker.
• Indicate course completion reporting requirements to CE Broker for approved providers and national organizations.
• Review the procedure for renewing a clinical laboratory license.

Continuing education license renewal requirements

Pp 13-16

Objectives

The participant will be able to:

Content (Top

Reading Assignment

• List penalties that the Board may impose.
• Identify the only licensee whose license was revoked from among 16 actual cases of disciplinary action.
• Specify the penalty for being unable to perform the duties of a clinical laboratory scientist by reason of use of alcohol, drugs, narcotics, or chemicals.
• Differentiate between disciplinary procedures that the Board may impose and citation violations.

Disciplinary guidelines

Pp 17-25

Objectives

The participant will be able to:

Content

Reading Assignment

• Specify extent of proficiency testing (PT) participation required.
• Specify requirements for new enrollment and changes to enrollment.

• Identify requirements for unregulated analytes.
• Indicate the meaning of “Not Graded” on a PT program results report.
• Differentiate between primary and back-up testing methods with regard to PT testing.
• Specify actions that should be taken when reviewing PT results.
• Indicate the significance of clerical errors in PT testing.
• Identify CLIA program requirements for PT failures.
• Distinguish between unsatisfactory and unsuccessful PT participation/performance.
• Identify reinstatement options.
• Recognize the implications of PT test referral.
• State action the laboratory should take with PT samples when it routinely performs only screening/presumptive testing methods on patient samples and then refers the samples to a reference laboratory.
• Define PT referral.
• Distinguish between categories of sanctions for PT referral.
• Place a PT referral scenario in its correct category.
• Distinguish between confirmatory, distributive, and reflex testing.
• Identify action a laboratory should take when another laboratory has submitted PT samples to them for testing.

Proficiency testing Frequently Asked Questions (FAQs)

Pp 27-54

• Specify sample size and frequency of PT testing.
• Identify consequences for a laboratory that is unsuccessful in PT performance on its main method for cholesterol.
• Specify enrollment by certificate/location requirements.

In general

• Specify requirements for PT sample handling/testing.
• State requirement as to when notification to CMS is required when a laboratory receives a PT sample from another laboratory for testing.
• Identify the sanction that is a statutory requirement for intentional PT referral.

Testing of proficiency testing samples

• Specify requirements for cytology screening PT.
• Identify PT passing score requirements.

Proficiency testing standards in general/ specialty/subspecialty requirements

Objectives

The participant will be able to:

Content

Reading Assignment

• List etiological agents that may be reported the next business day.
• Indicate reporting requirements for IgG and IgM serum antibody or viral culture test orders for measles or rubella.

Communicable diseases

pp 55-74

• Identify qualifications required for a laboratory supervisor in a licensed drug-testing laboratory.

Drug tests

• Specify rules that pertain to informed consent for HIV testing.
• Recognize conditions under which preliminary positive HIV screening results may be reported without corroborating or confirmatory HIV test results.

Human immunodeficiency virus testing

• Indicate the presence or absence of criminal penalties in the State of Florida for failing to test blood, plasma, organs, skin or other human tissue intended for transfusion or transplant for HIV or other communicable diseases.

Transfusions and Transplants: HIV Testing

• Specify blood collection requirements associated with newborn screening for disorders that may have pathologic consequences at birth or later in life.

Newborn screening

• List tests that may be conducted on-site at a multiphasic health testing center.

Multiphasic health testing centers

Objectives

The participant will be able to:

Content

Reading Assignment

• List the requirements of laboratory quality systems.

In general

Pp. 75–99

• Recognize a scenario in which a laboratory failed to comply with confidentiality regulations.
• Name the general laboratory monitoring system violated by a laboratory.
• Specify system requirements for communications.

General laboratory systems

• Identify staff requiring personnel competency assessment.
• Recognize three of CLIA’s minimal requirements for personnel competency assessment.
• Delineate the rules for competency assessment.
• Specify conditions under which a nurse manager can perform competency assessments of those performing moderate complexity point of care testing.

Personnel competency assessment

• Identify proficiency testing requirements when no approved PT program is available.

Evaluation of proficiency testing performance

• Define CLIA’s quality assessment program.

General laboratory systems assessment

• Specify CLIA requirements for standing orders.
• Indicate conditions under which oral test requests are permitted.
• Detail conditions under which a patient’s chart or medical record can be used as the test requisition or authorization.

Preanalytic systems

• Specify a requirement of the laboratory when it refers patient specimens to a reference laboratory.

Specimen submission, handling, and referral

Objectives

The participant will be able to:

Content

Reading Assignment

•   Identify procedure manual review, revision, and approval requirements.

Procedure manual

Pp. 101–143

•  Specify requirements for test systems, equipment, instruments, reagents, materials, and supplies.

Test systems, equipment, instruments, reagents, materials, and supplies

• Recognize applicable performance specifications.
•  State requirements that pertain when a laboratory receives a temporary replacement for an instrument (loaner).
• Specify operator variance requirements.
•   List performance specifications that must be established by the laboratory prior to reporting patient test results.
• Identify changes in test procedures considered to be laboratory modifications.

Establishment and verification of performance specifications

• Specify maintenance and function check requirements.

Maintenance and function checks

• Define calibration.
• Identify standards that apply to calibration materials.

Calibration and calibration verification

• Name the control procedure that exceeds CLIA requirements.
• Specify conditions under which the stated value of a commercially assayed control material may be used by the laboratory.
• Identify whether the referring or reference laboratory is responsible for performing the applicable quality control for the initial media used when cultures reported as “growth” are referred to the reference laboratory.

Control procedures

Objectives

The participant will be able to:

Content

Reading Assignment

• Identify an act that may be punishable by five years in prison.

Criminal offenses

pp 145–146

• Name an act prohibited by Florida law under the provisions of the Anti-kickback Statute.

Kickbacks

Objectives

The participant will be able to:

Content

Reading Assignment

• Detail the penalty for providers who engage in schemes to circumvent the Patient Self-Referral Act of 1992.

Physician self-referral

Pp. 147-148

Objectives

The participant will: be able to:

Content

Reading Assignment

• Distinguish between assault and battery.
• Differentiate between individuals who may or may not give consent to medical treatment.
• List requirements for obtaining consent to laboratory testing.

Consents

pp 173–181

Objectives

The participant will be able to:

Content

Reading Assignment

• Identify how incident reports may be used.

Incident reports

pp 183–187

• Specify the access patients have to their medical records.

Patient access to medical records

Objectives

The participant will be able to:

Content (Topics)

Reading Assignment

• Define negligence or malpractice and state the grounds for successfully suing for malpractice.

Malpractice liability

pp 189–199

• Differentiate between situations in which Good Samaritan immunity might or might not be granted.

Good Samaritan immunity

• Specify liability of clinical laboratory personnel who withdraw contaminated blood for transfusions.

Liability for contaminated blood