| Public health laboratory scientists Public health laboratory scientists are also regulated by the Board.
The table below outlines the various requirements for applicants to receive licensure for a public health laboratory.
Public Health Laboratory RequirementsDirectorFulfill the same requirements as a clinical laboratory directorSupervisorBe certified by National Registry in Clinical Chemistry or American Society for MicrobiologyBe licensed as a technologistHave five year's relevant experiencePass the state examTechnician (microbiology)Have a Bachelor's degree in one of the biological sciencesObtain American Society for Microbiology or the National Registry in Microbiology Certification in Public Health Microbiology
Technician (chemistry)Have a Bachelor's degree in one of the chemical, biological, or physical sciencesObtain National Registry of Clinical Chemistry Certification in Public Health ChemistryTechnician (conditional)Have a Bachelor's degree in one of the chemical or biological sciencesPerform tests only under the direct supervision of a licensed pathologist, director, supervisor, or technologist.Receives a conditional two-year license, which may be renewed only once
A license from the Board of Clinical Laboratory Personnel allows you to work in a public health laboratory at the same level and specialty. | View Page |
| Supervisor Qualifications Licensed as a technologist or meets the requirements to be licensed Completes a Board-approved two-hour course related to the prevention of medical errors that includes root-cause analysis, error reduction and prevention, and patient safety. Meets one of the following: Doctoral degree in chemical science, biological science, or clinical laboratory science + one year of laboratory experience in the category in which licensure is sought, and 25 hours of Board-approved continuing education in supervision and administration Doctoral degree in chemical science, biological science, or clinical laboratory science + one year of laboratory experience in the category in which licensure is sought, and DLM(ASCP) or CLSup(NCA) for all categories or ASCP specialty certification for the category in which licensure is sought Master's degree in chemical science, biological science, clinical laboratory science, or medical technology + three years of laboratory experience including one year experience in the category in which licensure is sought and either 25 hours of Board-approved continuing education in supervision and administration; or DLM(ASCP) or CLSup(NCA) for all categories or ASCP specialty certification for the category in which licensure is sought Bachelor's degree with 24 semester hours of academic science including 8 semester hours of biological sciences and 8 semester hours of chemical sciences + five years of lab experience, of which two must have been as a technologist and at least 1 year experience in the category in which licensure is sought, and either 25 hours of Board-approved continuing education in supervision and administration or DLM(ASCP) or CLSup(NCA) for all categories or ASCP specialty certification for the category in which licensure is sought. | View Page |
| Types of licenses Clinical laboratory personnel licenses are divided into four types: director, supervisor, technologist, and technician. Each type has different roles, responsibilities, qualifications, and continuing education requirements. When you apply for a license, you must apply for one of these four types. All licensed clinical laboratory personnel are permitted to collect, process, store, and ship specimens and perform manual pretesting procedures. Clinical laboratory personnel qualified as director (either physician director or licensed director), supervisor, technologist, or technician can perform testing within the specialty(ies) for which they are licensed. Each license is valid for one or more specialties. Directors, supervisors, and technologists are permitted to interpret and report test results. | View Page |
| Description of Specialties (3) Specialists in radioassay use radionuclides to determine the chemical makeup of body fluids such as blood and urine.
Specialists in blood gas analysis evaluate lung and breathing function by levels of oxygen, carbon dioxide, pH, and hemoglobin with automated tests.
Specialists in histology examine cellular and tissue samples using fixation, dehydration, embedding, microtomy, frozen sectioning, staining, and other similar techniques. Histology specialists licensed as technicians can perform specimen processing, embedding, cutting, staining, and frozen sectioning only under the general supervision of a director, supervisor, or technologist.
Specialists in cytology process and interpret samples relating cytopathological disease. Non-gynecological cytology preparations can be screen by a specialist in cytology but final review and interpretation must be done by a physician. | View Page |
| Continuing Education Requirements for Renewal All licensed clinical laboratory personnel must earn at least 24 hours of continuing education credits every two years. These continuing education hours must be completed by time your license.
Continuing education requirements include:At least one hour for each specialty for which you are licensedA two-hour course on medical errorsA one-hour course on laws and rules of the Florida Board (this course)A one-hour course in administration and supervision (directors and supervisors only)If you have just received your license, you do not need to complete this continuing education requirement during the first two-year period of your license, except for courses that may be required by your specialty. | View Page |
| License on probation An individual whose license that has been put on probation for violating the laws of the Board may be subject to any or all of the following requirements, as assigned by the Board: Practice only under direct supervision of a licensed clinical laboratory personBe reviewed on a quarterly basis by his / her supervisor, with reports submitted to the BoardSubmit a personal quarterly report to the Board describing the individual's progressComplete additional continuing education requirementsConsult a psychiatristNot consume alcohol or use any controlled or illegal substancesAttend AA or NA meetings weeklyUndergo and pay for random drug testingPay an administrative fineFailure to comply with all conditions of the probation will mean that the individual's license will be suspended or revoked. | View Page |
| Supervisor Responsibilities A supervisor is the laboratory director's designee for monitoring compliance with all applicable regulations of the board and the department. Other duties include: Performing the duties of a technologist, if needed, in the specialty area(s) where licensure is held Assigning direct supervision responsibilities to licensed technologists if needed, while ensuring that direct supervision of technicians is properly performed. Evaluating technologists' and technicians' competency in running tests and reporting results Being available to all personnel to answer questions and resolve problems Providing day-to-day supervision of test performance, including on-site direct supervision of testing that is performed by technicians Ensuring that quality control is performed and corrective action taken if necessary Ensuring that no patient testing is reported until corrective action has been taken and the test system is properly functioning Providing orientation to all testing personnel Implementing a quality maintenance program | View Page |
| Technician Responsibilities Technicians perform laboratory testing under direct and general supervision, as required by the test and the conditions of the technician's license. Other duties include:Performing tests only as authorized by the director and the technician's licensed specialty.Following the laboratory's procedure for specimen handling and running testsParticipating in proficiency testing and demonstrating that proficiency samples are tested in the same manner as patient samplesFollowing quality control and instrument calibration policiesDocumenting corrective action taken when results exceed the laboratory's acceptable performance valuesIdentifying potential problems with tests or report resultsNotifying a technologist or supervisor if results are outside the laboratory's acceptable performance levels | View Page |
| Competency and Licensing Violations Clinical laboratory personnel must be licensed and competent to perform their duties. This means holding the appropriate type of license for the task being performed (director, supervisor, technologist, or technician) and being certified in the appropriate specialty for any testing being performed. For example, an individual licensed as a technician in hematology may not perform the duties of a technologist in hematology, nor may that individual perform testing in the microbiology specialty.
Showing a lack of competence to perform even licensed duties is a violation of Board rules. Consistent errors can tarnish a laboratory's reputation, and even a single error can harm patient care. Licensed personnel must be certain that they can perform their duties accurately and competently.
All of the following are violations of Board rules:Performing clinical duties for which one does not hold a license.Performing services one knows one is not competent to perform.Showing lack of competence or making consistent errors in testing or reporting.Having a license revoked or suspended in another state. | View Page |
| Failing to Report a Violation Helping another person commit any of these violations of Board rules is also a violation, with substantial penalties.
If you know about a violation, you must report it to the appropriate authorities, perhaps your supervisor or lab director, or the Board itself. If you know about a violation and don't report it, you may have your license suspended or have to pay a fine. | View Page |
| Which of the following is NOT a responsibility of a clinical laboratory supervisor? | View Page |
| Which is NOT a category of Florida clinical laboratory license? | View Page |
| You cannot work in a clinical laboratory unless you have a four-year college degree. | View Page |
| If you know that a colleague has a drug problem that affects his / her work, you must report the colleague to the Board, your supervisor or director, or to another authority. | View Page |
| You notice that a co-worker seems to be making a lot of mistakes and has to ask you for help in performing routine tests. The co-worker has the right license and specialty, though. What should you do? | View Page |
| Which of the following continuing education courses are required for ALL new clinical laboratory supervisors, technologists, and technicians? | View Page |
| Management Personnel Responsibilities Management personnel (managers and supervisors) are the laboatory's first line of defense against allegations of fraud and abuse. They have a responsibility to protect the company from illegal and unethical actions by employees. Management personnel can be sanctioned for the actions of employees who report to them and they can be sanctioned for failure to detect violations. Management personnel have these responsibilities: Ensure that lines of communication remain open with employees. Ensure that employees understand their responsibility to report problems. Respond with appropriate seriousness when a problem is reported. Always follow-up on employees' questions and reports. Ensure proper documentation is kept concerning reported problems and report them to the next level of authority when appropriate. | View Page |
| Management's Responsibilities for Preventing Allegations of Medicare Fraud and Abuse Managers and supervisors are the company's first line of defense against allegations of fraud and abuse. Ensure that lines of communication remain open with employees. Ensure that employees understand their responsibility to report problems. Respond with appropriate seriousness when a problem is reported. Always follow-up on employees' questions and reports. Ensure proper documentation is kept concerning reported problems and report them to the next level of authority when appropriate. | View Page |
| Element 6 The laboratory monitors and regularly audits compliance activities, policies, and procedures to ensure they are being followed. If a problem is detected through the audit or monitoring process, it should be reported to the appropriate supervisor, manager, or the CO. | View Page |
| Issues Related to Test Ordering, Performance, and Resulting The laboratory can only perform tests that are ordered by individuals authorized to order tests. If an employee knows that a test has been ordered by someone other then an authorized individual, the employee should report it to their supervisor or the compliance officer (CO). The laboratory must have a system in place to detect tests that are not performed due to a laboratory error and stop or credit the billing for these tests. The laboratory cannot bill for tests that are not performed. An employee who is aware that a test has been canceled or has not been performed for some reason must follow the policies and procedures associated with correcting the billing. Release of test results Laboratory employees should release test results only to a person who is authorized to receive the test results. The Clinical Laboratory Improvement Amendments (CLIA) define an authorized person as: "an individual authorized under State law to order tests or receive test results, or both." Patients may be considered "authorized persons," if State law defines them as such. Refer to your own State laws regarding release of laboratory results directly to patients. | View Page |
| Case Study 9 The setting is a nursing home where a phlebotomist from the laboratory goes to draw blood samples each day. The phlebotomist picks up the requisitions for blood tests at the nursing station and then goes to the various rooms to draw blood from the patients. She notices that every requisition has an Advanced Beneficiary Notice (ABN) attached to it that is signed by the patient, even when the tests that were ordered don't need them. She asks the nurse at the station but she informs the phlebotomist that she doesn't know anything about it because it is done on the night shift.She lets the phlebotomist know that she will inform the nursing supervisor about it when she arrives at 9:00 AM. The phlebotomist completes her blood draws and returns to the laboratory. What should the phlebotomist do, if anything, in addition to her letting the nurse know about the problem?Correct Answer: The phlebotomist should report the incident to her supervisor upon returning to the laboratory.Discussion: Since the laboratory is submitting the claims for any Medicare patients that the phlebotomist might draw, the problem is the lab's problem. However, it is not going to change the fact that the ABNs were already signed by the patients if the phlebotomist refuses to draw them or if the nursing personnel are required to remove them. By contacting the supervisor, an appropriate representative from the laboratory can follow up with the nursing supervisor to ensure they understand the laws and regulations that govern ABNs. | View Page |
| Case Study 8 The setting is a billing office in a laboratory where clerks work in close proximity to each other, so that each can easily see what the other is doing. A billing clerk notices that one of his fellow employees is changing or adding codes to requisitions he is processing. This employee is a friend of his and he knows that he really needs the job at the laboratory because he is a single parent raising two kids. He also knows that what the employee is doing is against the company's compliance policies.He asks the employee about it and is given the explanation that because the computer requires something to be entered in the ICD-9 code field and he only does this with non-Medicare patients, it doesn't matter. The employee explains that it gives him more time to call for codes for the Medicare patients. What should this clerk do about this situation?Correct Answer: He should talk to the supervisor about the problem even if he talks to his fellow employee about it and the employee says he will stop doing it.Discussion: Every employee who becomes aware of a violation of the law or a compliance policy has a responsibility to take action, which includes reporting the problem to a supervisor or the compliance officer. It doesn't matter that these patients are not Medicare patients, the important thing is that the employee is violating a compliance policy. If this employee does not report the problem he is himself violating a compliance policy. If it is subsequently discovered that he knew and didn't report it, he could be terminated. The employee's addition of the codes could create a big problem for the lab iif an audit or inspection occurred. | View Page |
| Case Study 1 A billing clerk is entering billing demographics on requisitions as a part of the normal days work. The department is under pressure to reduce accounts receivable, which means that the more clean claims that are filed, the better. This particular requisition is for a Medicare patient and has an LMRP test but does not have a diagnosis on it. She remembers that just a few requisitions before this one she had a requisition from the same doctor that had this same test on it that did have a diagnosis that allowed the test to be billed. She thumbs back in the pile and finds the previous requisition, notes the code that was used and adds it to the current requisition. This will help her meet the department goal of getting claims paid and reducing accounts receivable. Can she do this?Correct Answer: She should not do this because it is against the law to change diagnosis information on a requisition.Discussion: A laboratory employee should never change, add or use previously received diagnosis information for the purpose of making a test billable for the Medicare program or for any other insurance or payer. This is a form of fraud and for each claim submitted as a result of this activity, the laboratory is liable for a false claim and would have to pay the government back up to three times the reimbursement for the test and up to $10,000 for each claim submitted. If the employee is caught doing this, even if the employee is ignorant of the law and any laboratory policy prohibiting it, she must be disciplined along with her supervisor. Any employee who notices another employee doing this should correct the employee and report the incident to the department supervisor immediately. | View Page |
| Laboratory Billing Department Communication With Physicians and Patients It is important that billing department employees are clear and accurate when communicating with physician office personnel and patients. Never guess at the answer to a question; ask if you are unsure. Do not speculate or express personal opinions. When requesting diagnosis information from the physician office staff, be careful to not lead them to give a billable code. The code must come from the patient's medical record. Billing department employees must accurately state laboratory policies and procedures, or forward the call to a supervisor to avoid misstatements and misunderstandings. | View Page |
| Element 6 Element 6:
The laboratory monitors and regularly audits compliance activities, policies and procedures to ensure they are being followed.If a problem is detected through the audit or monitoring process, it should be reported to the appropriate supervisor, manager or the CO. | View Page |
| Confidentiality All employees have a responsibility to maintain the confidentiality of medical information.
Medical information should never be discussed outside of the laboratory.
It should only be discussed with the ordering doctor or an authorized representative of the doctor.
Employees should verify the identity of the individual requesting such information
Employees who communicate with patients, physicians or their office staff, insurance company representatives or government employees about any laboratory activity should only give information they know to be true and accurate.
Employees should never give false information and should never guess the answer to any question.
In case of doubt, refer the person to a supervisor.
| View Page |
| Tests performed and ordered correctly The laboratory has a system in place to detect tests that are not performed due to a laboratory error and stop or credit the billing for these tests.
The laboratory cannot bill for tests that are not performed.
Employee aware of a test being canceled or not being performed for some reason must follow the policies and procedures associated with correcting the billing.
The laboratory only performs tests that are ordered by individuals authorized to order tests.
If an employee knows that a test has been ordered by someone other then an authorized individual, the employee should report it to their supervisor or the CO.
| View Page |
| Communication with physicians and patients It is important that billing department employees are clear and accurate when communicating with physician office personnel and patients.
Never guess at the answer to a question; ask if you are unsure.
Do not speculate or express personal opinions.
When requesting diagnosis information from the physician office staff be careful to not lead them to give a billable code:
The code must come from the patient's medical record.
There is an incentive program for patients to find and report fraud and abuse by health care providers, including laboratories, so:
Billing department employees must accurately state laboratory policies and procedures, or forward the call to a supervisor to avoid misstatements and misunderstandings.
| View Page |
| Special role for managers/supervisors All compliance guidance documents point to leadership support as critical to an effective compliance program.Ethics and compliance go hand in hand.Managers have a responsibility to protect the company from illegal and unethical actions by employees.Managers can be sanctioned for the actions of employees who report to them.Managers can be sanctioned for failure to detect violations.Managers and supervisors are responsible for employee actions and must:
Talk to employees about compliance issues.
Ensure employees understand violations are serious.
Ensure employees understand that disciplinary action will be taken.
| View Page |
| Preventing whistleblowers Managers and supervisors are the company's first line of defense.Ensure that lines of communication remain open.Ensure that employees understand their responsibility to report problems.Respond with appropriate seriousness when a problem is reported.Always follow-up on employees questions and reports.
Ensure proper documentation is kept concerning reported problems and report them to the next level of authority when appropriate. | View Page |
| Case Study 9 The setting is automated chemistry department, night shift, busy core laboratory for a hospital based outreach laboratory. A medical technologist who operates the automated chemistry analyzer on third shift encounters short samples a couple of times a night. When this happens, he runs as many of the ordered tests as he can and fills in the blank results with a comment indicating that a short sample occurred. As far as he knows there isn't a policy that addresses this problem directly.The test reports out with the results and the comments. The technologist does not have to change the physician order in any way and is providing the maximum results that can be reported for the specimen in a timely fashion. This is done as a matter of patient care and quality service. There has not ever been a complaint about this practice as far as he knows. Are there any additional steps this technologist should be taking?Correct Answer: The technologist should follow the procedures that the laboratory has in place for testing and billing samples for which there is no order or for ambiguous orders. If the policies do not seem to address his particular situation, he thinks there should be a separate policy to cover this situation or has a question about it, he should talk to his supervisor or to the laboratory compliance officerDiscussion: This choice addresses the problem in the most complete manner, in that the employee fulfills his responsibility to take action when he thinks there is a problem.
| View Page |
| Case Study 10 The setting is nursing home where a phlebotomist from the laboratory goes to draw blood samples each day. The phlebotomist picks up the requisitions for blood test orders at the nursing station and then goes to the various rooms to draw blood from the patients. She notices that every requisition has an Advanced Beneficiary Notice (ABN) attached to it that is signed by the patient, even when the tests that were ordered don't need them. She asks the nurse at the station but she informs the phlebotomist that she doesn't know anything about it because it is done on the night shift.She lets the phlebotomist know that she will inform the nursing supervisor about it when she arrives at 9:00 AM. The phlebotomist completes her blood draws and returns to the laboratory. What should the phlebotomist do, if anything, in addition to her letting the nurse know about the problem?Correct Answer: The phlebotomist should report the incident to her supervisor upon returning to the laboratory.Discussion: Since the laboratory is submitting the claims for any Medicare patients that the phlebotomist might draw, the problem is the labs problem. However, it is not going to change the fact that the ABNs were already signed by the patients if the phlebotomist refuses to draw them or if the nursing personnel are required to remove them. By contacting the supervisor, an appropriate representative from the laboratory can follow up with the nursing supervisor to ensure they understand the laws and regulations that govern ABNs. | View Page |
| Case Study 8 The setting is a billing office in a laboratory where two or more clerks work together in very close proximity with each other, so that each can easily see what the other is doing. A billing clerk notices that one of his fellow employees is changing or adding codes to requisitions he is processing. This employee is a friend of his and he knows that he really needs the job at the laboratory because he is a single parent raising two kids. He also knows that what the employee is doing is against the company's compliance policies.He asks the employee about it and is given the explanation that because the computer requires something to be entered in the ICD-9 code field and he only does this with non-Medicare patients, it doesn't matter. The employee explains that it saves him a lot of time he uses to call to get codes for the Medicare patients. What should this clerk do about this?Correct Answer: She should talk to the supervisor about the problem even if she talks to the employee about it and the employee says she will talk to the supervisor and stop doing it.Discussion: Every employee who becomes aware of a violation of the law or a compliance policy has a responsibility to take action, which includes reporting the problem to a supervisor or the compliance officer. It doesn't matter that these patients are not Medicare patients, the important thing is that the employee is violating a compliance policy. If this employee does not report the problem he is himself violating a compliance policy. If it is subsequently discovered that he knew and didn't report it, he could be terminated. If there is a need for refunds to be done or other action, it will not occur and could create a big problem for the lab in a subsequent audit or other action. | View Page |
| Case Study 1 A billing clerk is entering billing demographics on requisitions as a part of the normal days work. The department is under pressure to reduce accounts receivable, which means that the more clean claims that are filed, the better. This particular requisition is for a Medicare patient and has an LMRP test but does not have a diagnosis on it. She remembers that just a few requisitions before this one she had a requisition from the same doctor that had this same test on it that did have a diagnosis that allowed the test to be billed. She thumbs back in the pile and finds the previous requisition, notes the code that was used and adds it to the current requisition. This will help her meet the department goal of getting claims paid and reducing accounts receivable. It is all right for her to do this because:Correct Answer: She should not do this because it is against the law to change diagnosis information on a requisition.Discussion:
A laboratory employee should never change, add or use previously received diagnosis information for the purpose of making a test billable for the Medicare program or for any other insurance or payer. This is a form of fraud and for each claim submitted as a result of this activity the laboratory is liable for a false claim and would have to pay the government back three up to times the reimbursement for the test and up to $10,000 for each claim submitted. Further, if the employee is caught doing this, even if the employee is ignorant of the law and any laboratory policy prohibiting it, she must be disciplined and so should the supervisor. Any employee who notices another employee doing this should correct the employee and report the incident to the department supervisor immediately. | View Page |
| In Case of a Spill Small spills (as defined by your facility) may in most instances be handled by laboratory or other employees. However, if you experience symptoms of overexposure during the clean up, such as burning eyes, or throat irritation, immediately leave the cleanup area and get help from your institution's Spill Response team or other designated persons.Major spills (as defined by your facility) will usually require immediate assistance from the Spill Response team or other designees. There are several ways to clean up small spills, two of which are described below:1. Dike up the formaldehyde with absorbent pillows. Then dispose of these pillows in a sealed, formaldehyde-labeled container. 2. A chemical that reacts with and neutralizes formalin may be used to treat the spill.Your supervisor will show you the location of these emergency spill clean-up materials or discuss alternative procedures. Be sure to follow your own institution's policies and procedures in regard to formalin spills. | View Page |
| Safety Data Sheet The appropriate SDS (Safety data sheet) for formalin can be found in your laboratory's SDS book or online. You should know where to access the SDS and be familiar with its content. Direct any questions you may have to your supervisor. | View Page |
| How is Exposure to Formaldehyde Monitored? A monitoring badge is attached to your lab coat collar in the "breathing zone" for a specified length of time. This badge is then sent to an outside laboratory by your supervisor to determine your level of exposure to formaldehyde. | View Page |
| Monitoring Results The employer will review the results of the monitoring and, according to the OSHA Formaldehyde Standard, CFR 1910.1048, must inform each affected employee of the results within 15 working days after the receipt of the results. Notification can be given either individually in writing or by posting the results in an appropriate location that is accessible to employees. If employee exposure is above the PEL, affected employees shall be provided with a description of the corrective actions being taken by the employer to decrease exposure. | View Page |
| Goals of this Program Locate potentially hazardous chemicals in your workplace. Explain how to obtain a copy of a material safety data sheet (MSDS). Explain the information included on chemical labels. Identify exposure control measures.The intent of th to recognize potentially hazardous chemicals in the workplace, be able to locate the paper copies of material safety data sheets (MSDSs) in the laboratory, or know how to obtain an electronic copy of an MSDS when needed. The goals also include able to explain the information that is included on chemical labels and choose to use engineering controls, personal protective equipment and safe work practices to avoid exposure to hazardous chemicals. | View Page |
| Your Responsibility Read the manufacturers' labels and safety data sheets (SDS), and follow the instructions and warnings. Access pertinent safety information through your supervisor. If you are concerned that something is a potential hazard, either in the facility or in your work procedures, contact your supervisor as soon as possible. | View Page |
| Read the Label! Before you move, handle or open a chemical container, READ THE LABEL and follow the instructions. If you are not sure about something, ask your supervisor before you act. | View Page |
| Right to Know As an employee, you have the right to know the types of hazardous substances that are used in your workplace. Material safety data sheets are now referred to as safety data sheets (SDSs) under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). SDSs must be available to you for each chemical used in the laboratory, either in paper or electronic form. Ask your supervisor for the exact location. | View Page |
| To Request a MSDS To request an MSDS from your supervisor, do so in writing and it will be made available to you within 15 working days. | View Page |
| Common Sense Rules Make these common sense rules a part of your job: Identify hazards before you start a job. Don't take chances. Ask your supervisor when in doubt. Be prepared! Know how and where to get help. | View Page |
