| Your Role As a clinical laboratory worker, your role is vital in the health care process. You provide information to doctors, nurses, and healthcare organizations that is vital to proper patient care. Because your role is so important, you must be properly qualified, trained, and licensed for your position. You must also keep up with the latest laboratory techniques and developments by fulfilling continuing education requirements; and you are bound by a code of ethics, which ensures that patient results are accurate, reliable, and free from error and bias. | View Page |
| Director Qualifications Effective date March 17, 2008All applicants for a Director license must meet the qualifications for a high complexity laboratory director that are defined in 42 CFR 493.1443 as published on October 1, 2007.A licensed physician may direct a clinical laboratory without a separate laboratory director's license if he / she is certified in clinical pathology by the American Board of Pathology (ABP) or the American Osteopathic Board of Pathology (AOBP); is board-certified in the pertinent laboratory speciality; and/or has four years of pertinent clinical laboratory experience (post-graduate) with two years experience in the speciality that will he/she will direct.A non-physician may obtain a director's license for a specialty area if he / she: Holds an earned doctoral degree in a chemical, biological, or clinical laboratory science Is certified in the pertinent laboratory specialty by an approved national board A director can oversee up to five laboratories. | View Page |
| Capability Violations The accuracy and safety of patient testing depends on the capability and honesty of clinical laboratory personnel.
If an individual's ability to perform testing is influenced by illness, injury, drug use (legal and illegal), or alcohol use, he or she may no longer practice. The Board can order a doctor's exam to determine if illness, injury, drugs, or alcohol is a factor. The individual can get his / her license back after recovery and proving that the condition is no longer a problem.
If an individual commits a crime in any state relating to matters of honesty (such as filing false reports or advertising false services), that individual's Florida license may be suspended.
Other licensed personnel who know that an individual is practicing despite being under the influence of drugs or alcohol, is physically or mentally incapable, has been convicted of a lab-related crime, or is not competent to perform his / her duties are required to report the individual to the Board.
The following are violations of Board rules:Continuing to practice after becoming unable to safely perform testing because of illness or use of alcohol or drugs, or another mental or physical condition.
Continuing to practice after being judged mentally or physically incapable.Being convicted of any crime relating to activities of clinical laboratory science or involving dishonesty or lack of morals.
Failing to report to the Board that one has been convicted of a crime (as listed above), been judged mentally or physically incapable, or had a licensed revoked in another state.
Knowingly allow an unqualified person to perform clinical laboratory duties.
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| 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.
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| Panels and profiles Panels and Profiles:
It is not against the law for a laboratory to allow the use of panels, profiles and custom panels.
The laboratory must ensure that the ordering doctor knows what tests are included in a panel or profile and what CPT codes will be billed to the Medicare program.
The laboratory notifies doctors about panels and profiles through a written notice and the requisition.
Employees should not permit the order of any panel or profile not authorized by the laboratory.
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| Test pricing and antitrust It is not against the law for a laboratory to have different fee schedules for different billing situations.Most laboratories have one fee schedule for customers that must be billed individually (patients, insurance, Medicare) and one for customers billed monthly on an invoice type of statement (client or doctor billing).The difference in price between the two schedules should be a reflection of the financial benefits of direct client billing.Test prices should be determined by means of a financial analysis that include such factors as cost, market value and reasonable profit.Contractually arranged pricing that results from negotiations with insurance and managed care companies should at least cover costs of testing.Laboratories may not work together to fix or set prices in the market place. | View Page |
| Communicating with patients in person When communicating directly with patients concerning their laboratory tests or orders be careful not to discuss the following:
Why a test has been ordered by a physician.
What the test might indicate or what the test results mean.
Any opinions about their doctor.
Any information about internal laboratory issues.
Refer the patient to their doctor for information about the tests and the results.If the laboratory provides any printed information about tests that are designed for patients, give the patient that information. | View Page |
| Test orders Anytime an order is not clear, the physician office must be contacted.Do not use information supplied by a patient to clarify an order. Patients cannot add tests on their own. If a patient insists they want tests not specifically ordered by the doctor, the doctor should be contacted.When transferring a doctor's order from a non-standard form like a prescription pad to a laboratory requisition, it is important to ensure the accuracy of the order.Attach the original order document to the requisition sent to the laboratory.Follow all laboratory policies about panels and profiles, ambiguous orders and reflex tests. | View Page |
| Case Study 3 It is 11:00 PM and the specimen processing department is finishing up the night's accessioning and test requesting. A specimen processor is working on a requisition that has an order for a Hepatic Profile but there are two tubes of blood with the order, one of which is a lavender top tube. This is the fourth requisition from this same doctor's office and all of them have had a lavender top tube and serum tube with an order for a chemistry test and a CBC. No CBC is marked on the requisition or written on the tube. The specimen processor figures the office just forgot to mark the test and knows that the results will be delayed and the sample might not be any good if he doesn't order the CBC now. He is also under pressure from the technical departments to finish processing on time so they can get their work done on time for result printing in the morning. What should the processor do?Correct Answer: Look up the laboratory's policy for handling such a situation and follow the policy.Discussion: The laboratory is not permitted to change a doctor's order in any way. By ordering the CBC the processor is ordering a test that the doctor did not specifically order and therefore makes the laboratory subject to a violation of the False Claims Act. By reviewing and following the laboratory policy the processor assures that the laboratory, the physician and the patient's best interests are met. | View Page |
| Case Study 4 Busy hospital laboratory in a 350 bed urban hospital that provides laboratory testing for the hospital and for the hospital's outreach testing laboratory. A medical technologist in the microbiology department receives a call from a friend who works in a laboratory in a physician office. The physician is not a regular client of the laboratory currently but uses another laboratory for most of their work. The microbiologist knows that the sales department would like to get this account. The friend explains to her that she is doing a quality control check on her in-office microbiology testing and her regular laboratory will do it but is going to charge her for it. She asks the microbiologist if she will do it for free since it is quality control, not Medicare and is not going to be billed to anyone.She tells the microbiologist that she would like to use the hospital lab for everything but her doctor insists on using the competitor. She indicates that the favor might help get the doctor to try the hospital laboratory for other tests. The microbiologist should:Correct Answer: Explain to her friend that if the hospital does the tests for no charge on the promise of other referrals, both the physician office and the hospital could be liable for violations of the antikickback statute.Discussion: The antikickback statute is implicated in this scenario because the free testing is solicited on the condition that other referrals may occur as a result of providing the favor. In fact, the solicitation itself is a violation of the law. The fact that Medicare patients are not specifically mentioned in the scenario is not sufficient to remove the risk. The technologist should also report the incident to the Compliance Officer and seek advise about what documentation, if any, should be kept concerning the incident. | 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 |
| Panels and profiles Panels and Profiles: It is not against the law for a laboratory to allow the use of panels, profiles and custom panels. However, all applicable CPT codes must be included. The laboratory must ensure that the ordering doctor knows what tests are included in a panel or profile and what CPT codes will be billed to the Medicare program. The laboratory notifies doctors about panels and profiles through a written notice and the requisition. Employees should not permit the order of any panel or profile not authorized by the laboratory. | View Page |
| Test pricing and antitrust It is not against the law for a laboratory to have different fee schedules for different billing situations.Most laboratories have one fee schedule for customers that must be billed individually (patients, insurance, Medicare) and one for customers billed monthly on an invoice type of statement (client or doctor billing).The difference in price between the two schedules should be a reflection of the financial benefits of direct client billing.Test prices should be determined by means of a financial analysis that include such factors as cost, market value and reasonable profit.Contractually arranged pricing that results from negotiations with insurance and managed care companies should at least cover costs of testing.Laboratories may not work together to fix or set prices in the market place. | View Page |
| Case Study 3 It is 11:00 PM and the specimen processing department is finishing up the night's accessioning and test order entry. A specimen processor is working on a requisition that has an order for a Hepatic Profile but there are two tubes of blood with the order, one of which is a lavender top tube. This is the fourth requisition from this same doctor's office and all of them have had a lavender top tube and serum tube with an order for a chemistry test and a CBC. No CBC is marked on the requisition or written on the tube. The specimen processor figures the office just forgot to mark the test and knows that the results will be delayed and the sample might not be any good if he doesn't order the CBC now. He is also under pressure from the technical departments to finish processing on time so they can get their work done on time for result printing in the morning. What should the processor do?Correct Answer: Look up the laboratory's policy for handling such a situation and follow the policy.Discussion: The laboratory is not permitted to change a doctor's order in any way. By ordering the CBC the processor is ordering a test that the doctor did not specifically order and therefore makes the laboratory subject to a violation of the False Claims Act. By reviewing and following the laboratory policy the processor assures that the laboratory, the physician and the patient's best interests are met. | View Page |
| Case Study 4 A busy laboratory is located in a 350 bed urban hospital that provides laboratory testing for the hospital and for the hospital's outreach testing program. A medical technologist in the microbiology department receives a call from a friend who works in a laboratory in a physician office. The physician is not a regular client of the laboratory currently but uses another laboratory for most of their work. The microbiologist knows that the sales department would like to get this account. The friend explains to her that she is doing a quality control check on her in-office microbiology testing and her regular laboratory will do it but is going to charge her for it. She asks the microbiologist if she will do it for free since it is quality control, not Medicare, and is not going to be billed to anyone.She tells the microbiologist that she would like to use the hospital lab for everything but her doctor insists on using the competitor. She indicates that the favor might help get the doctor to try the hospital laboratory for other tests. How should the microbiologist respond to this request?Correct Answer: Explain to her friend that if the hospital does the tests for no charge on the promise of other referrals, both the physician office and the hospital could be liable for violations of the antikickback statute.Discussion: The antikickback statute is implicated in this scenario because the free testing is solicited on the condition that other referrals may occur as a result of providing the favor. In fact, the solicitation itself is a violation of the law. The fact that Medicare patients are not specifically mentioned in the scenario is not sufficient to remove the risk. The technologist should also report the incident to the Compliance Officer and seek advise about what documentation, if any, should be kept concerning the incident. | 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 |
| A 55 year old female, who recently returned from an extensive trip to China, presented to her physician complaining of diarrhea and abdominal cramps. The doctor ordered a complete blood count (CBC), chem 21 panel, and stool for culture and parasite examination (O & P). The CBC revealed pronounced eosinophilia. The chem 21 and stool culture were unremarkable. The O & P revealed suspicious forms like the one below that each measured approximately 140 µm by 80 µm. This patient is most likely infected with: | View Page |
| A 43 year old female presented to her doctor for a routine check-up. Her only complaint was that she had been experiencing watery stools that occasionally contained pus and blood. Examination revealed tenderness in her abdomen. A stool for parasite study was sent to the lab. Two suspicious forms were seen. The oblong form on measured 53 µm by 60 µm whereas the rounder form measured 45 µm by 37 µm. Use the pulldown boxes to identify each picture: | View Page |
| A 27 year old male was seen in the emergency room complaining of diarrhea. He had no other symptoms and was in very good health. The doctor ordered a stool for culture and parasite study. The culture revealed no enteric pathogens. This suspicious form was seen on the wet preparations and the permanent stain. It measured 16 µm. With which of the following parasites is this patient most likely infected? | View Page |
| A 31 year old male missionary worker recently returned from Africa where he helped a small rural community update their sanitation practices. He presented to his physician weak and complained of recent weight loss, abdominal pain, and diarrhea that was often bloody. The doctor ordered a battery of tests including a complete blood count (CBC) and stool for parasite examination. The CBC revealed eosinophilia and anemia. This suspicious form was seen on the wet preparations. It measured 52 µm by 27 µm. What parasite is mostly likely present? | View Page |
| A 44 year old female immigrant from Southeast Asia presented to the local clinic complaining of fever, chills, diarrhea and weakness. Patient history revealed that the woman worked in a research laboratory in her homeland. Her primary project was to develop an effective insecticide for the dreaded sandfly. The doctor decided to culture her blood for parasites. This form, measuring 14 µm, was recovered. The patient is most likely suffering from: | View Page |
| A 50 year old male domestic airline pilot was rushed to the hospital after complaining of tremendous fluid loss due to severe diarrhea. History revealed that the patient was diagnosed with AIDS 6 months ago. The doctor ordered a battery of tests including a stool for parasite examination. Since the sample was properly labeled indicating that the patient was immunocompromised, the lab performed both the standard processing procedures and a modified acid-fast (mod AFB) stain. The mod AFB stain revealed this suspicious form which measured a mere 4 µm. This patient is most likely infected with: | View Page |
| An 18 year old female athlete, who recently competed in a barefoot run for charity in Southern Georgia, presented to her doctor for a routine check-up. Other than complaining of being exhausted and having occasional diarrhea, she was in good health. The doctor ordered a stool for culture and parasite examination. The culture was negative. Numerous suspicious forms, as that shown here, were seen upon microscopic examination of the stool. The name of this suspicious form is: | View Page |
| A 12 year old female went to her doctor for her yearly back-to-school check-up. She was in good health and was asymptomatic at the time of the examination. Due to the increased incidence of parasites in the area, the doctor ordered a stool for parasite examination as part of the routine physical testing. Multiple suspicious forms, measuring approximately 9 µm each were seen. Which of the following is most likely the identification of these forms? | View Page |
| A 58 year old male, who recently returned from an extensive overseas business trip to Africa, presented to the local clinic complaining of nausea, vomiting, and an achy feeling all over his body. At first he thought it was just the flu, but it persisted. The doctor ordered a battery of tests including blood smears for parasitic study. This suspicious form was recovered. The patient is most likely suffering from: | View Page |
| A 45 year old mother of two went to her physician because her children were recently diagnosed with ascariasis and she was concerned that she had also contracted the disease. Other than complaining of recent sporadic diarrhea, she was in overall good health. The doctor ordered a stool for ova & parasite examination. This suspicious form, measuring 55 µm was seen throughout the sample. This form is most likely: | View Page |
| A 16 year old male champion athlete went to his doctor complaining of a persistent cough, fever, bloody diarrhea and overall weakness. Upon questioning the patient, it was learned that he had recently competed in a freshwater swimming competition in the Caribbean. Examination revealed a dermatitis on the patient's right calf. A battery of tests were ordered including a CBC, chemistry profile, and a stool for culture and parasitic examination. The CBC revealed the presence of eosinophilia. The other hematology and chemistry tests were unremarkable. The culture was negative. This suspicious form was seen on all parasite preparations made from the stool sample submitted. This form measures 165 µm by 68 µm. This patient is most likely suffering from an infection with: | View Page |
| A 27 year old female graduate student recently returned from South America, where she completed a nature study of the rain forest. She spent months "living off the land." The woman went to her physician seeking treatment for a sinus infection, which she thought was responsible for several recent bouts of diarrhea. Upon questioning the patient, the doctor decided to collect stool for culture and parasitic examination. The stool culture was reported as "no enteric pathogens isolated." This suspicious form was seen on both wet preparations and on permanent stain. It measures 17 µm. The identify of this form is most likely: | View Page |
| A 40 year old male recently completed a two-week hiking expedition in Russia. Upon his return to the United States, the man presented to his physician complaining of severe foul-smelling diarrhea and abdominal discomfort. The doctor immediately suspected a parasitic infection and ordered stool for examination. The sample was loaded with this suspicious form that averaged 13 µm in length. This patient is most likely suffering from: | View Page |
| A 17 year old female went to her doctor complaining of diarrhea. With the exception of seasonal allergies, she was in relatively good health. Patient history was unremarkable. A stool was submitted for culture and parasite examination. The culture was reported out as "no enteric pathogens isolated." This suspicious form was seen on wet preparation and permanent stain. It measures 27 µm. This patient is most likely suffering from which of the following conditions: | View Page |
| A 40 year old male just returned from a six-month tour of the Far East. He went to his doctor upon his return complaining of weakness, diarrhea, fever and cough. Upon questioning the patient it was learned that he spent many an evening swimming in the various local fresh water ponds. The doctor, suspicious of a parasitic infection, ordered a stool for examination. Two suspicious forms were seen: form 1 is roundish and measures 77 µm by 62 µm. Form 2 is long and ladder-like and lays on the edge of form 1. What are these two structures? | View Page |
| A stool collected at a local doctor's office was received in the laboratory for parasitic examination. The sample was not received in fixative and due to the new courier system did not arrive in the lab within the traditionally acceptable time frame. Due to logistical difficulties of the patient collecting and submitting another sample, the laboratory director authorized the sample to be processed. The comment "specimen delayed in transit, please evaluate results accordingly" was included in the report. These two suspicious forms were seen upon examination of the specimen. Label these two forms: | View Page |
| A 6 year old female presented to the local clinic complaining of intense perianal itching and diarrhea. The doctor ordered a cellophane tape prep and stool for routine culture and parasitic examination. The cellophane tape prep revealed suspicious form on the left. The stool culture was negative. The form on the right was seen upon examination of the stool for parasites, which measures 10 µm. Label these two suspicious forms: | View Page |
| A 29 year old male steak house owner from Arizona presented to his doctor complaining of weight loss, abdominal pain and diarrhea. Patient history revealed that the man eats all of his meals at his restaurant and his favorite meat is rare sirloin steak. The man also noted that he had recently been on anti-parasitic medication. The doctor ordered a stool for parasitic examination. These two suspicious forms were seen. The patient is most likely suffering from an infection with: | View Page |
| A 35 year old man presented to his doctor with fever, diarrhea, abdominal pain and epigastric discomfort. Upon questioning the patient, it was learned that he travels extensively on business and loves to try new kinds of raw fish. The patient is most likely suffering from: | View Page |