Laboratory Information and Courses from MediaLab, Inc.

The cerebrospinal fluid sample should be properly labeled with the tube number, patient's name and hospital number. The samples should be transported to the laboratory immediately.

Normal cerebrospinal fluid has the following characteristics:colorlessclearno clot presentspecific gravity of 1.006 - 1.008pH 7.3When the specimen is received in the laboratory, the macroscopic examination is performed immediately. The specific gravity examination may be optional in some laboratories.

In the cytospin procedure, use a high speed centrifuge to concentrate the cells on a slide in a uniform monolayer 6 mm in diameter. The monolayer distribution enhances the morphological appearance of the cells present.Allow the slides to dry in air for several minutes and then stain them with Wright-Giemsa stain. Cytospin slides may be placed in an automatic stainer, such as Hema-Tek, or stained manually.Perform a 100 or 200 cell differential and record the number of neutrophils, eosinophils, basophils, lymphocytes, monocytes, macrophages, and blasts cells.Pathologists must review any slide which has tumor cells, unidentified cells, or immature stages of cells, such as blasts.Since criteria for review may vary from one laboratory to another, be sure to check the requirements in your laboratory before reporting the differential.

Although the procedure is simple to perform, accurate results depend on careful adherence to manufacturer’s directions and adequate quality control. Normal and abnormal controls should be tested whenever a new lot of strips is opened, and at the frequency defined by the laboratory's procedure. If quality control results do not correspond to the published control values, the problem must be resolved before patient samples are tested. High levels of ascorbic acid (Vitamin C) in the urine may inhibit some reagent strip reactions, such as glucose, blood, bilirubin, nitrate and leukocyte esterase. The urine dipstick's package insert will provide information about potential interfering substances, including ascorbic acid. Intensely colored urine may make it difficult to correctly interpret color reactions on the dipstick. The affected tests should not be reported from the dipstick. It would be necessary to use an alternative method of testing if available.

False negative results occur when elements present in the urine interfere with either the enzymatic reaction or prevent the oxidation of potassium iodide. Examples of such substances include: large quantities of ketones aspirin ascorbic acid > 50 mg/dL with some reagent strips levadopa 5-hydroxyindoleacetic acid homogentisic acid sodium fluoride ( a preservative)A specific gravity higher than 1.020 may lower glucose reagent sensitivity, especially in the presence of a high urine pH. Exposing reagent strips to excess humidity may also reduce glucose reagent reactivity.Check the package insert of the reagent strips used in your laboratory for interfering substances that may affect glucose results.

Several manufacturers offer semi-automated instruments (dipstick readers) for reading reagent strips. Use of an instrument removes the subjectivity of visually interpreting color changes on reagent strips, and assures that tests will be read at the correct time. Transcription errors will also be avoided if the instrument is interfaced with the laboratory information system. The technology employed is based on the principle of reflectance, with the amount of light reflected being inversely related to the concentration of substances present. An example of reflectance is the light which is scattered after light strikes an unpolished surface. Since each component on the dipstick produces a different color reaction, the light source for each test must be at the appropriate wavelength. This is accomplished either by using filters or monochromatic light sources. The percent reflectance is determined by dividing the test reflectance by the calibration reflectance and multiplying by 100. Algorithms are used to change the results obtained into a linear relationship with concentration of analyte.

A routine reagent strip protein method, based on the principle of "protein error of indicators," produces a visible colorimetric reaction that is capable of detecting most instances of proteinuria.Traditionally, laboratories have used sulfosalicylic acid (SSA) to confirm all positive protein reagent strip results, but this practice is not as common in today's laboratories. SSA is a precipitation method that reacts with all forms of protein. However, any substance that is precipitated by acid will produce false-positive SSA results. This includes radiographic dyes, cephalosporins, penicillins, and sulfonamides. SSA may be used as a secondary protein detection method if the urine is highly alkaline (pH of 9.0 or greater) which would overwhelm the buffering capacity of the reagent on the protein reagent stick. SSA may also be used as an alternative protein detection method if the urine is highly colored so that the colorimetric reaction is masked on the reagent strip.

The product profile for Ictotest® points out that bilirubin is very light sensitive, so urine specimens should be protected from excessive light exposure and examined as quickly as possible when received in the laboratory. On standing, bilirubin, which has a goldish color, is oxidized to biliverdin, which is a green color. Many of the procedures used to detect bilirubin will not react with biliverdin, so false-negative results may occur if urine is not fresh when tested.

Record the test result that is associated with the color block that most closely matches the color of the test in the tube. Remember that the final color may not be the test result if the "pass through" phenomenon occurred. Test results should be recorded according to your laboratory's procedure. Laboratories may choose to record results as 1%, 2%, 3%, etc; 1+, 2+, 3+, etc; or 100mg/dL, 200mg/dL, 300mg/dL, etc. The result of the test in the top image is negative, and the result of the test in the bottom image, reported as a percentage, is 2%. (Note: Colors in the photograph may vary slightly from actual test colors.)

Smith KR, Fisher HC III, Hook, EW III: Prevalence of fluorescent monoclonal antibody-nonreactive Neisseria gonorrhoeae in five North American sexually transmitted disease clinics.J Clin Microbiol 34:1551-1552, 1996We compared a direct fluorescent monoclonal antibody (DFA) test with alternative enzymatic and fermention tests for identifying presumptive gonococcal isolates in a systematic sample from patients attending five sexually transmitted disease clinics in five cities.Fourteen (2.5%) of 556 isolates from three clinics were nonreactive with the DFA confirmatory reagent and reactive by both the Quad-Ferm and Rapid NH tests. The prevalence of DFA-nonreactive Neisseria gonorrhoeae isolates varies geographically and is independent of local methods for the identification of possible gonococci.On the basis of our findings, we recommend that for use in medicolegal and other instances in which a diagnosis of gonorrhea has the potential to have far-reaching effects, it is appropriate to test DFA reagent-nonreactive, oxidase-positive, gram-negative diplococci by alternative methods of gonococcal confirmation.Although the prevalence of such isolates could change, the fluorescent monoclonal antibody confirmation reagents remain useful for many clinical situations. Their ease of use and ready applicability for screening large numbers of isolates make them useful for many laboratories.

A 72- year old woman had a history of recurrent urinary tract infections over the past several months, for which she had received different regimens of antibiotics including ampicillin, trimethoprim-sulfasoxazole, and ciprofloxacin.Relapses often occurred 10 days to two weeks after cessation of therapy.The current flare up, manifest by dysuria, lower abdominal pain and cloudy urine was accompanied by shaking chills and spiking fever.A sterile mid-stream urine specimen was sent to the laboratory for culture.

Vancomycin and ampicillin resistance among Enterococcus species, particularly E. faecium have been on a steady increase.The disk diffusion screening test is used in many laboratories to detect vancomycin resistant strains. Note in the upper photograph that no zone of inhibition is seen around either the vancomycin or the ampicillin disk, indicating resistance to both drugs.Vancomycin-resistant Enterococci (VRE) have been divided into three phenotypes--Van A, Van B, and Van C.Vancomycin-resistant strains of E. faecalis and E. faecium are commonly of the Van A phenotype, demonstrating high level resistance (MIC's higher than 64 ug/mL), as illustrated by total resistance of the test strain in the E test and the VA disk, as illustrated in the lower photograph.The strain shown in the lower photograph, however, is ampicillin susceptible at the level of 1 ug/ml (see lower set of yellow arrows), indicating that this drug may be effective in treating the urinary tract infection.

Perhaps the most efficient means for detecting methicillin-resistant staphylococci in clinical laboratories is the use of the agar dilution screening test.Illustrated in the photograph is a Mueller-Hinton agar plate containing 6ug/ml of oxicillin, previously inoculated with a strain of Staphylococcus aureus. Oxacillin is used as a marker for methicillin resistance because it is more stable in the agar medium. Growth on this screening medium is presumptive for methicillin resistance.Thus, in the presence of growth, as shown here, a follow-up MIC test must be performed to determine the exact level of resistance.

The prototype history for this organism is either a still birth or a neonate with death ensuing within 2 or 3 days post-partem due to high fever, sepsis, and respiratory distress. The mother usually experienced a flu-like illness late in the third trimester of pregnancy, characterized by low-grade fever, myalgias, malaise and backache. In this case, biopsy material of brain tissue obtained at autopsy was submitted to the pathology laboratory for tissue diagnosis and fluid from the pia-arachnoid was sent to the microbiology laboratory for culture.

While the Federally Regulated CCF must be used exclusively for DOT drug screen collections, there are extenuating circumstances when another form of CCF may be used. For example, where a post-accident collection must be made and the collector does not have time to obtain a Federally Regulated CCF. In this situation, a Non-Federally Regulated CCF may be used. The collector should note in the "Remarks" section why the Non-Regulated CCF was used.The use of a Non-Regulated CCF for a Federally Regulated collection is not a reason for the laboratory to refuse to test the specimens nor the Medical Review Officer (MRO) to release the results. The use of a Non-Regulated CCF for a Federally Regulated drug screen is a "correctable flaw," which may include the collector detailing the reason for using a Non-Federally Regulated CCF in a "Memorandum for Record."

Scenario 4:The donor returns from the restroom with a sufficient specimen. It is very warm to the touch. The collector is unable to obtain a reading off the temperature strip.Collector's Response:The collector completed the collection and prepared the specimen for shipment. The collector then told the donor that a new collection under direct observation would be conducted because the collector was suspicious of substitution or adulteration since the temperature of the specimen was not within acceptable range (90-100º F/32-38º C). A new CCF was initiated. The collector checked the "Observed" box on the CCF and noted in the "Remarks" section why the collection was observed. The collector also noted the control number of the suspect collection. The observed specimen along with the suspect specimen were both shipped to the laboratory in separate plastic tamper-resistant bags.

Scenario 5:The collector noticed that the urine the donor had just handed to her had a very strong smell like that of a cleaning product, such as bleach.Collector's Response:The collector completed the collection in the usual manner, and then explained to the donor that, because of the strong, unusual smell, the first specimen was suspected for adulteration. The collector then told the donor that an observed collection would now be done. Both the "suspect" specimen and the specimen collected by direct observation are sent to the laboratory for testing.Besides an unusual smell, other indications of adulteration might be an unusual color that cannot be explained my medication, particles, or debris in the urine, and a heavy or thick foam that is inconsistent with urine.

This program has provided some basic information about emergency situations that can occur in a laboratory.However, it is not a substitute for a hands-on first aid course, such as those that may be given at a local community center.The more you know about first aid, the more prepared you will be to act calmly and effectively in emergency situations, possibly saving lives.

Specimen rejection criteria established by your laboratory should be followed at all times, as improperly collected or processed coagulation specimens could adversely affect patient results. Generally speaking, hemolyzed specimens should not be used in coagulation testing because ADP liberated from lysed red blood cells can interfere with a number of coagulation tests, especially those involving platelet assessment. Grossly lipemic specimens may cause erroneous results or a clot may not be detected if a photo-optical coagulation system is used. An alternative method that is not affected by lipemia, such as an electromechanical method, may be required One way to avoid a grossly lipemic specimen is to ask the patient to fast prior to specimen collection.

The INR component of the laboratory result is a calculated value that is used by the clinician to monitor anticoagulant therapy and adjust dosage as dictated by clinical status. An INR of 2.0 - 3.0 is often desired as the therapeutic range. The following formula is used by the clinical laboratory to derive an INR value. The INR must be adjusted for every new lot of PT reagent. INR= (PT of patient/PT of geometric mean of the normal population)ISI The International Sensitivity Index, or ISI value, is provided by the reagent manufacturer as the relative sensitivity of the reagent itself. The INR is used to standardize PT results, and in turn, anticoagulant therapy, across laboratory instrumentation, methodologies, and locale. Be sure to frequently check that ISI values match those of the lot currently in use as erroneous results may otherwise occur .

The privacy regulations give covered entities permission to use and disclose PHI for treatment, payment, and health care operations (TPO), without obtaining specific authorization.A covered entity may disclose PHI to other covered entities such as reference laboratories, and homecare services, which are providing services to the primary covered entity.The service that the other covered entity is providing must fall within treatment, payment or health care operations (TPO).If the service being provided does not fall within TPO, an authorization is generally required.An authorization form must state the specific disclosures of PHI to be made, what the information will be used for, and must be signed and dated by the patient.

You will have many opportunities to avoid disclosing protected health information. Here is one simple example: Your best friend asks you to look up her mother's laboratory results. Knowing the HIPAA privacy regulation and your own departmental policies and procedures, you do not disclose the protected health information which she is requesting. You politely tell your friend that your are not allowed to give her the laboratory results.

Prevention of HIV exposure is the best line of defense to prevent occupational transmission of HIV as there is no vaccine available to develop specific immunity and the postexposure prophylaxis is toxic. Following appropriate workplace practices in the laboratory focus on preventing needlesticks or other sharps injuries and exposure of mucous membranes and abraded skin to HIV-infected blood or body fluids.

They are easily available.Biological pathogens can be obtained from nature, hospital  laboratories, university research facilities, etc.They can be hard to detect.Small quantities can have potentially deadly or incapacitating effects on a susceptible population.They can be used covertly.They can be spread throughout large areas by natural convection, air or water currents. They can be easily spread.Ventilation systems in buildings is one way biological agents may be spread. In addition, transportation facilities could become part of the dissemination system by carrying biological agents far from their initial source.

The LRN is a multilevel system designed to link frontline clinical microbiology laboratories and hospitals and other institutions to state and local public health laboratories in supporting advanced capacity public health, military, veterinary, agricultural, water and food testing laboratories at the federal level. Laboratories within the LRN are divided into 3 levels: Sentinel Labs, Reference Labs, and National Labs.

At the highest level are the “national” laboratories. Examples would include those operated by CDC, the United States Army Medical Research Institute for Infectious Diseases, and the Naval Medical Research Center. These laboratories have very unique resources to handle highly infectious agents and the ability to identify specific agent strains.

Level 3 laboratories are responsible for: Working with hospitals and private laboratories in their jurisdiction Knowing how to properly collect and ship clinical specimens Ensuring that specimens, which can be used as evidence in a criminal investigation, are properly handled and that chain-of-custody procedures are followed Being familiar with chemical  agents and how they can affect health and well-being Training on anticipated clinical sample flow and shipping regulations Working to develop a coordinated response plan for their respective state and jurisdiction

At present, 5 laboratories participate in Level 1 activities. At this level, technical personnel are trained to detect exposure to an expanded number of chemicals in human blood and urine. This includes all Level 3 and 2 laboratory analyses, plus analyses for mustard agents, nerve agents, and other toxic chemicals.

Recent events, including the terrorist attacks on September 11, 2001 and the subsequent bioterrorist releases of anthrax, have been a harsh awakening that the nation’s workplaces could be terrorist targets.Traditionally laboratory safety guidelines have emphasized use of optimal work practices, appropriate containment equipment, well-designed facilities, and administrative controls to minimize risks of unintentional infection or injury for laboratory workers. Today, in addition to the above, laboratories must make a risk and threat assessment, secure data and electronic technology systems, plus develop policies regarding specimen accountability, facility security, and emergency response.The next few pages will cover a number of things that you can do to assist in making your laboratory more risk free to a terrorist attack and some things you can do in case that security is breached. You too have a role in the security of your workplace!

In some laboratories the anticoagulated sample is used to prepare concentrated smears. Placing the fluid in a Wintrobe tube and centrifuging it separates the sample into four layers:fat and perivascular cellsplasmabuffy layer - myeloid and nucleated erythroid cellserythrocytesThe volume of each layer is measured using the scale on the Wintrobe tube and then the percentage of each layer is calculated. Next the plasma is removed and a smear is made from the buffy coat and top of the red cell layer. Either the manual push method or cytospin technique may be used to make the smears. They may be stained with a variety of cytochemical stains. Concentrated smears are used to examine cell morphology and demonstrate the presence of abnormal cells when the marrow is hypocellular. The smears cannot be used for differential counts or evaluation of cellularity.

Quality control procedures may include the following: monitoring variables within the laboratory, like water quality, glassware calibration, and instrument calibration, that may affect results defining protocols for performing quality control for each test procedure participating in proficiency testing programs graphing quality control results performing daily and periodic analysis of quality control data and charts troubleshooting quality control errors documenting quality control errors, including the steps taken to resolve the problem and verification of success performing routine maintenance of laboratory instruments keeping records

Internal quality control is set up within a laboratory to monitor and ensure the reliability of test results from that laboratory.The primary tool for internal quality control is called a control. A control is a specimen with a predetermined range of result values, called control values, that is processed in the same manner as a patient sample. Control samples are processed with each series or run of patient samples.If the result of a test on a control sample is different from its known value, this indicates a problem in the equipment or the methods being used.

To ensure reliability of results, many other factors besides controls are monitored. These include: water quality analytic balance calibration glassware calibration centrifuge calibration thermometer calibration electric power stability heating bath temperatures refrigerator temperatures freezer temperatures expiration of reagents, standards, and controls instrument maintenance procedure manuals, including written step-by-step procedures of all tests performed by laboratory method selection, based on local population and clinician needs normal range verification based on the local population technical competencies of laboratory staff members

External quality control is performed to ensure the reliability of test results between different laboratories. It is also required by CLIA for laboratory accreditation. External quality control is generally accomplished through proficiency testing (PT). In proficiency testing, simulated patient samples are sent out to laboratories for testing. The CLIA standards for handling proficiency testing specimens are as follows: PT samples must be tested with the laboratory's regular patient load. PT samples must be tested the same number of times that patients' samples are tested routinely. Laboratories participating in PT programs must not engage in interlaboratory comparison of PT sample results. Laboratories may not send PT samples to another laboratory for analysis. Laboratories must document all steps of processing for PT samples. PT is required for only the primary method used for testing of analytes in patients' samples during the period covered by the PT event.In return for their participation, the laboratory will receive the following information: results for each analyte sample mean result for each analyte standard deviation of results by the comparative method number of laboratories using the same method standard deviation index (SDI) lower and upper limits of acceptability of resultsPT results that are between the lower and upper limits of acceptability are considered satisfactory. For chemistry, 80% of samples must test within the acceptable range for the PT to be considered successful. External quality control serves several purposes, including: providing a check on internal quality control detecting errors in a lab's methods providing a comparison of testing methods, which is useful in selecting new methods

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.

To practice as a clinical laboratory scientist in the state of Florida, you must have an appropriate Florida license. Without a license, you cannot conduct clinical laboratory examinations or report test results. You do not need a Florida license to work in:Laboratories run by the federal government.Labs that perform only waived testing.Labs run exclusively for research and teaching purposes that do not report patient results.These laboratories may have other licensing and training requirements.

A physician may direct a clinical laboratory without a director's license if he / she is certified in clinical pathology by a national board and has at least four years of relevant experience. Non-physicians may obtain a director's license if he / she:Holds a doctor's degree in chemical, biological, or clinical laboratory scienceIs certified in one of the laboratory specialties by a national boardPasses an exam in supervision and administrationCompletes one hour of HIV / AIDS continuing educationCompletes two hours of medical errors continuing education A director can oversee up to five laboratories.

A supervisor is responsible for the day-to-day performance of laboratory testing and adherence to laboratory procedure. Other duties include:Performing technologist or technician duties as needed, if properly licensedConducting direct supervision of technologists and technicians if required by the test or the technologist's or technician's licenseEvaluating technologists' and technicians' competency in running tests and reports resultsBeing available to all personnel to answer questions and resolve problemsEnsuring that quality control is performed and corrective action taken if necessaryScheduling tests and personnelUpdating policy manualsProviding methods to identify, access, store, transport, and dispose of specimensFollowing company policy

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

Offering or taking a bribe, kickback, bonus, commission, or inducement is against the rules of the Board and against the law. Many companies give away small promotional items, such as pens or note pads, to promote their products. This is legal, but be cautious about accepting more valuable items. This could be seen as a bribe. All of the following are serious violations of Board, state, and federal rules:Participating in any commissions, bonuses, kickbacks, inducements, or split-fee arrangements from physicians, health care providers, suppliers, hospitals, nursing homes, other clinical laboratories, pharmacies, and other facilities.Exploiting or influencing a patient for financial gain, including promoting, selling, or withholding services, drugs, or referrals.

Laboratory professionals can learn about medical errors and prevention by maintaining their awareness of laboratory-related news and events. They can read print and online news sources, magazines, and professional journals to stay informed. They can also learn what is happening through televised and other media reports. Staying up to date about current trends and progress in error prevention enables professional to learn from mistakes and prevent new ones.

Laboratory discussion meetings help to prevent medical errors. The staff can meet periodically to discuss recent averted adverse events and ones that might have been averted.Discussion should not be about blame. Privacy must be protected, so real names should not be identified. Management can provide guidelines for discussion and analysis.A suggested format for discussion:1. Briefly describe each adverse event.2. Identify its possible causes.3. Discuss relevant guidelines.4. Suggest possible preventive actions.Discussion can include actions that do and do not work to prevent medical errors.

Medical errors are possible at any phase of patient care. Preanalytic medical errors begin with the patient and the places he or she receives medical care--the bedside, chair-side, hospital, clinic-- wherever the patient is located. The possibility for these errors continues through the ordering processes for medical tests or procedures. Preanalytic medical errors also happen with the systems, processes, and procedures involved in the collection of test samples from patients. These medical errors occur during the time before the laboratory is directly involved in assaying and analyzing test samples. Examples of preanalytic medical errors: Wrong patient Wrong test Wrong timing Wrong collection procedure Wrong tube, container, additive

Errors also occur after analyses are completed and reported. Postanalytic errors begin with the medical professionals who receive test results, and they include interpretation of the results. These errors can occur at--the bedside, chair-side, hospital, clinic-- wherever the patient and the medical professional are located. The possibility for postanalytic medical error continues through diagnosis and treatment procedures and processes. These medical errors occur during the time after the laboratory reports test results. Examples: Wrong test value associated with patient Wrong test interpretation Wrong diagnosis Wrong treatment Laboratory professional might believe they are not associated with postanalytic medical errors, but they can. One deadly example is fatal hemolytic transfusion reactions involving laboratory errors.

The government believes that fraud, abuse and waste exist in the healthcare industry today because of cases it has settled and prosecuted.All healthcare providers, including laboratories, make billing errors.The Office of Inspector General (OIG) believes that honest members of the healthcare community can police themselves if they receive guidance.The OIG has published Compliance Program Guidance documents for health care providers, including laboratories.

Element 7: The laboratory has a duty to respond to problems it detects either through its auditing or monitoring system or as reported by employees.It is required to take corrective action and review policies and procedures to ensure the problem does not occur again.It is required to discipline or retrain employees if necessary.The laboratory will report problems to appropriate government agencies and return any money to which it is not entitled.

Element 2: The laboratory has appointed a Compliance Officer (CO) and a Compliance Committee to serve as the focal point for all compliance activities and decision making.The CO and any member of the compliance committee is accessible to all employees in the laboratory.

Element 4: The laboratory has established a system of communication so that employees can and are encouraged to report problems and suspect activities they might observe or discover, without fear of retribution, including an anonymous option.The anonymous system instructions are posted throughout the laboratory.

Social Security Act: Medicare and Medicaid laws are in this act. Medicare rules and regulations come under this act. Antikickback laws: Provide criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive money or favors for referrals of tests or services that will be paid for by the Medicare or Medicaid programs. False Claims Act: Provides criminal penalties for knowingly or willingly filing a false claim to a government program. Self Referral (Stark) laws and regulations: Identify financial relationships that have the potential to result in directed referral to one or both of the individuals or entities involved. Prohibit the referral of patients or tests between related entities unless certain conditions are met. Health Insurance Portability and Accountability Act (HIPAA) Prohibits health care providers and payers from improper or inappropriate use of a patient's confidential health information Requires health care providers to insure that a patient's confidential information is kept secure Provides for standardized electronic formats for all health care transactions

Billing: Highest risk activity a laboratory has. All laboratory activities contribute to the billing process. Many of the risk areas included in this program are components of the billing function. Medical necessity: Medicare is only allowed, by law, to pay for tests that are reasonable and necessary for the diagnosis and treatment of disease. Medical necessity is an underlying principle of the Medicare program. Tests performed for screening or routine exams are not considered medically necessary by the Medicare program.

Advance Beneficiary Notices (ABNs) allow laboratories to bill Medicare patients directly for specific tests that are not covered by Medicare. A laboratory cannot bill a Medicare Beneficiary for a laboratory test unless it notifies the patient in writing that Medicare is not going to pay for the test. This notice is called an ABN. The beneficiary can choose not have the test performed if they do not want to pay for it. Laboratories cannot make all Medicare beneficiaries sign ABNs. The ABN must contain the specific name of the test. The ABN must give a specific reason the laboratory thinks payment for the test will be denied. The beneficiary should sign the ABN and be given a copy.

Requisitions must be designed to ensure that ordering physicians can choose tests that are medically necessary for their patients. Requisitions should contain reminders about Medicare rules of medical necessity and list the contents of panels and profiles. Requisitions must provide a place for the physician to include diagnosis (ICD9-CM) codes. Physicians should be encouraged to use only the requisitions supplied by the laboratory to order tests. Ambiguous or unclear test orders When the orders for a test are not absolutely clear, the laboratory must contact the ordering physician to clarify the orders before performing and billing for the test. The laboratory cannot guess at the order. The laboratory cannot perform and bill for tests that are not specifically ordered. The laboratory cannot change a physician order without contacting the physician. In any case where specimen integrity or patient care will be compromised by a delay in testing follow the policies the laboratory has established for such cases.

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.

It is against the law to offer or ask for money or favors to get a physician to order tests from a laboratory. This is known as an "inducement" or a "kickback." Laboratories should only give supplies to a physician for the drawing, processing, storing or transporting of specimens to the laboratory. The laboratory cannot provide supplies physicians use for their own purposes. The laboratory must monitor the amount of supplies provided to ensure that it matches the number of tests sent to the laboratory. The lab cannot give free tests except in the event of laboratory error. The lab cannot give free education to clients unless it is about the laboratory's services or policies. The lab cannot give excessive or expensive gifts or entertainment to physicians The lab can give discounts but the price must be above cost and at "fair market value."

The laboratory's couriers may not transport items except those related to the testing services offered by the laboratory. Couriers must follow all OSHA standards for the handling and transport of specimens. The laboratory is responsible for all tests it refers to other laboratories. Laboratory should not change CPT codes supplied by a reference laboratory without contacting the reference laboratory. The laboratory is responsible for all tests it bills to Medicare/Medicaid even if the test was performed by a reference laboratory.

Laboratories must not induce physicians to order unnecessary tests through their marketing or education activities: They must monitor the use of laboratory services by their clients. They must correct any situation where something they did caused an unnecessary increase in test utilization. Cost Reports Hospitals laboratories must ensure that information used in hospital Medicare cost reports is accurate and includes only those costs which are appropriate. Laboratories must follow all CLIA and OSHA regulations: failure to do so may result in a False Claims Act violation.

Medical necessity means that Medicare is not allowed by law to pay for any tests that are not necessary for diagnosis or treatment of disease.A laboratory may not submit a claim to Medicare or other government payers for any test it knows is not medically necessary except in certain cases: When the patient has signed an advance notice. When a patient has requested the lab to submit such a claim for a determination by Medicare. Medicare does not pay for screening tests or tests that are ordered in the absence of signs or symptoms.Billing department employees are responsible to follow all policies and procedures related to the submission of claims to reduce erroneous billings.

ICD-9CM (International Classification of Disease, 9th Edition, Clinical Modification) codes are used for the classification of disease and conditions and for describing signs, symptoms and medical circumstances.These codes are used to indicate the medical necessity of a particular test.ICD-9 codes can only be supplied by the ordering physician or a representative of that physician. "Code steering" means to steer or direct a physician to supply an ICD-9 code that is payable. ICD-9 codes cannot be used from a previous laboratory order. If a physician supplies a narrative description instead of an ICD-9 code the laboratory must accurately translate that code using only certified coders.It is against the law to use the wrong ICD-9 code for the purpose of causing or increasing payment for a test.

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.

The laboratory should not offer or provide free testing to any individual in a position to make or control referral for laboratory services: The laboratory may write off charges only when laboratory errors in billing or testing occur. Sales and marketing personnel cannot offer free testing in any form unless approved by the compliance officer. Free testing for indigent patients must be approved by the compliance officer. Sales and marketing personnel cannot offer or give anything of value to a customer or potential customer beyond the usual promotional items. If a client solicits a questionable or illegal item or special consideration, it should be reported to the sales manager or compliance officer.

Laboratories may only lease space from physicians who refer Medicare patients to them under certain circumstances: There must be a written lease for at least one year. Lease price must be at "fair market value." All leases must be reviewed by legal counsel to ensure compliance with antikickback and Stark laws.When leasing or renting equipment to a physician or from a physician the same basic rules apply as for space.If the laboratory is located in a hospital, the relationship between the hospital and a physician who refers to the lab may have antikickback or Stark implications.

Never use sign and symptom information received from a patient for laboratory billing purposes.Never use ICD-9 codes from previous visits for a new visit even if the request is for the same test and the patient assures you that it is for the same reason. (Standing orders are an exception.)ICD-9 codes should be requested when setting up standing orders and will then apply to all subsequent visits. It is not necessary in this case to get a new ICD-9 code for each visit.If the patient refuses to sign an ABN but demands to have the test done: Have the fact that they were given notice (ABN) witnessed by a second person. (By phone if you are located in single-person drawing site). Ensure that documentation is complete.

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.

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.

The setting is the cafeteria in a hospital or the lounge in an independent laboratory. Two employees from different departments are old friends are having lunch together. A billing clerk and a medical technologist are friends and are having lunch together. The billing clerk mentions that she saw a bill go through the system for one of her coworkers for a biopsy. She asks the medical technologist if she has the necessary security level access to see pathology test results because she is concerned about the welfare of the coworker. The medical technologist does have the necessary security clearance to see the results. She should:Correct Answer: Refuse to look up the results for the clerk and remind the clerk that it is a violation of compliance policies to do so, or to ask another to do so. Remind her of the requirement for each employee to report any violations of policy. Discussion: The Medical technologist has a responsibility to report violations of compliance policies and the friend has put her in a difficult position. For that reason, it is not enough to just refuse the clerk's request. If the medical technologist does not take the responsibility to inform the employee of the policy then there is a possibility that the employee would ask some other employee to do it for her.

The Client Services department which is a crowded room divided into cubicles which contain desks separated only by thin moveable dividers. Lots of activity, phones ringing, multiple conversations going on at once etc. A client service representative receives a call from a large client office that she speaks with every day for a variety of reasons. Today the client is requesting the laboratory to write off the charges for a test that the office person ordered incorrectly by mistake even though the laboratory has already done the test and reported the results back to the office. Since this service representative works with this office frequently she believes that this is a rare request. Actions that the client service representative may take are:Correct Answer: Refuse to write off the charges for the test and inform the client that it could be considered an inducement if the laboratory does that, which would make both the laboratory and the office liable should it ever come to light. Offer whatever billing options are available according to lab policies. or Refuse to write off the charges and explain to the client that approval must be obtained from the department manager or the laboratory compliance officer before any action can be taken because writing the test off could be considered an inducement.Discussion: The primary reason is that the test is not written off simply because the client asks for it to be done.