Physician Information and Courses from MediaLab, Inc.

A 29-year-old female of Philippine descent was seen by her physician for fatigue. The patient states that a relative told her that their family has a long history of anemia.She presented with sclera icterus and her spleen was palpable. Routine blood work was initially ordered.

In addition to 5S and the waste walk, other tools are considered essential in a Lean system. These tools are listed below:Lean Process/ConceptDefinitionLaboratory ApplicationPull systemA system where supply and production are dependent on demand. Instead of ordering the same amount of supplies on a fixed time interval, a laboratory utilizing a pull system would review data from the analyzer test counter or take inventory to match the order to the testing demand. Continuous flowOne-for-one process. No waiting between steps. Linking the rate of demand to the rate of production. Patient moves from registration to blood draw area to doctor without waiting.Blood sample arrives in the laboratory, is received, processed, and tested immediately rather than waiting to batch. Set up reductionPreparation of the work area and supplies in advance so that the process proceeds smoothly. Set up supplies into ready-to-use kits. Perhaps these can be set up by the prior shift during slow times. Error-proofing A system that doesn't let a worker make a mistake. Can be used in combination with visual signals. Many point-of-care instruments have automatic lockout of testing if quality controls are not tested, or if they fail, prior to patient testing. Value stream mapA picture that illustrates the flow of material, inventory, and product. Value stream maps are used for value stream analyses, which can allow an organization to identify waste in its processes through Lean thinking. The value stream map should start from the supplier and end at the customer. In a clinical laboratory the start would be when the physician place the order or when the courier drop off the sample. And the end would be when the results are sent to the client or physician. Different processes: preanalytical, analytical and postanalytical within the laboratory are included in-between. The value stream map can help to identify unneeded or non-value-adding steps and provide a high level review of the entire process.Takt time and level loadingTakt time is a measurement of the process flow over time that will help determine how to combine work to achieve the best flow. Based on the takt time, level loading helps to balance the volume and variety of work among employees so that work progresses at a more even pace. Cross-training allows a laboratory worker to help in another department when there is a lull in their department's workflow.

While the role of the hematopathologist in the interpretation of bone marrow samples is well defined, the role of the technologist can vary greatly depending on the laboratory and the clinical setting.In some cases, physicians deliver prepared bone marrow smears to the laboratory that they have been prepared at the patient's bedside . In other settings, the technologist assists in the bone marrow collection procedure by making bone marrow smears at the bedside. There are also situations where a physician will bring anticoagulated bone marrow in specimen tubes to the laboratory for the technologist to smear, stain, and distribute as the hematopathologist requires.Once the marrow smears are prepared and stained, the next steps will vary depending on the laboratory. In some institutions it may be the hematology or oncology fellows/attending physicians who are responsible for counting and evaluating the aspirate smears, while the biopsy samples go to pathology. In other settings it may be the technologists who perform the differentials while hematopathology completes the evaluation and interpretation.

The cerebrospinal fluid sample is obtained by a physician usually via lumbar puncture in the L3-L4 region. The opening pressure is first measured (nl 90-180 mm of water in lateral position) and if it is elevated greater than 200 mm, no more than 2 ml of CSF should be withdrawn. Sterile technique is always used to reduce the risk of infection. Care must be taken to avoid injury to neural tissue.

It is important to recognize that xanthochromia is the appearance of color in the supernatant of a fresh, centrifuged CSF sample. There are a variety of causes for the appearance of this color. Therefore, it is important that xanthochromia be reported. The physician is responsible for determining the reason for its presence.

A 24-hour urine protein may be ordered if a large amount of protein is detected with the dipstick method or if protein persists in the urine. A 24-hour urine protein may also be ordered if the physician suspects the release into the urine of protein other than albumin.

A 24-hour urine protein may be ordered if a large amount of protein is detected with the dipstick method or if protein persists in the urine. A 24-hour urine protein may also be ordered if the physician suspects the release into the urine of protein other than albumin.

For monitored collections, the Department of Transportation classifies the following as health professionals: Physician Medical Technologist Medical Laboratory Technician Nurse (RN/LPN) Physician's Assistant/Nurse Practitioner Medical Technician (A medical technician is anyone who is licensed or certified to practice in the institution where the collection is being done. For example, a phlebotomist, EMT, or medical assistant.)

There are some instances where a dermal puncture is prohibited or not recommended.Mastectomy patientsAs a general rule, a dermal puncture, or a venipuncture, should not be performed on the side affected by a mastectomy. The body's ability to fight infection is compromised if lymph nodes were removed. A physician's permission must be obtained before performing a blood collection procedure on the same side as a mastectomy. Edematous siteDermal punctures should not be performed on previously punctured sites or swollen sites. Excess tissue fluid may contaminate the specimen.Dehydrated patientIf the patient is dehydrated or has poor circulation, it may be impossible to get a quality specimen. Fingerstick on a newborn or young infant Dermal punctures must never be performed on the fingers of a newborn or very young infant (usually defined as under 12-months-old). There is very little distance between the skin and the bone. Therefore, the bone could be easily pierced during the puncture, causing injury to the bone, infection, or gangrene.

Coefficient of variation is commonly used as a means of measuring the variability of an instrument. The data are gathered by recording the values for the normal and abnormal controls for each test run. At the end of the month, the standard deviation, mean, and coefficient of variation are calculated. The testing data for a particular instrument might look like this:Normal ControlAbnormal ControlsCVsCVJanuary100.92.432.41209.54.412.11February103.12.992.90211.64.001.89March102.02.212.17206.83.951.91The coefficient of variation stays fairly constant from month to month. If there is a sudden increase, there might be a problem with the method or the equipment.In the clinical laboratory, the use of CV as a measure of relative variability should not be confused with the use of the standard deviation as a measure of absolute variability. For example, support physicians agreed that for accurate patient treatment, the inherent variability in a glucose method should be less than 5 mg/dL. In this case, neither the hexokinase nor the orthotoluidine method is acceptable. It does not matter which is more precise if neither is precise enough to result in adequate patient care.

Case StudyA young patient is admitted from the emergency room with petechial bruising. The attending physician orders a battery of tests including a PT and aPTT. The laboratory performs the requested testing and the result of the aPTT is normal; however the PT is prolonged:PT: 38 seconds (normal range 11-13 seconds)aPTT: 32 seconds (normal range 21-34 seconds)The physician then decides to order a mixing study for further analysis since the patient is not taking any oral anticoagulants, nor does she meet the known patient histories associated with prolonged PT results.

A 50-year-old male with a family history of diabetes visits his physician for routine physical. He reports that he feels his health is excellent. He exercises regularly, but often his diet is high in calories and fat.Physical Examination: Slightly overweight; blood pressure and pulse normal.A basic metabolic panel and PSA are ordered. All results are within reference range except the plasma glucose. The patient's physician orders a hemoglobin A1C (HbA1C) the following week.Laboratory results:Fasting plasma glucose (FPG)= 110 mg/dL (Reference interval 75 - 100 mg/dL)One Week Later:Hb A1C= 6.0% (Reference interval 4 - 6%)

Before glucose meters were available, urine glucose was frequently used to approximate diabetic glucose levels. Blood glucose levels can be related to urine glucose concentration because of urinary excretion of glucose. Physician offices, clinics, and patients at home tested urine with reagent strips for a semi-quantitative measurement of urine glucose and adjustments in insulin therapy were made. Monitoring a diabetic carbohydrate management is seldom performed this way today. Portable meter measurement of blood glucose is a much better management method. Urine glucose measurement is neither sensitive nor specific and does not give information about blood glucose below the renal threshold (usually 180 mg/dL).As a semiquantitative measurement, urine glucose is a routine assay on urinalysis test and an abnormal result would be investigated with blood levels. If quantitative measurements are needed, a timed urine specimen is collected and measured for glucose by blood glucose methods.

In this course we have described some emerging cardiovascular risk markers. It is important to note that there are many more markers, some of which appear robust and which may have clinical value. Examples of other risk markers that are emerging but were not discussed are listed in the table to the right.An important question that should always be asked is "how many risk markers do we need?" With so many risk markers available, the laboratory needs to research which markers are truly the strongest and most valuable for the patient demographic the facility deals with most and which markers physicians will order and utilize.

Serum lipoprotein electrophoresis is usually performed using fasting serum or plasma. In a fasting sample, large chylomicrons are not normally present and therefore, will not obscure or confound the gel. Because electrophoresis relies on dye-binding and densitometry, samples should have cholesterol > 100 mg/mL. The results of this testing can be used in a variety of ways but typically a report of "type B" or "type A" is sufficient to inform physicians whether there is increased cardiovascular risk.

Adverse drug reactions are a leading cause of morbidity and mortality in the United States. Drug metabolism is a process whereby drugs are delivered to the body, distributed, metabolized and then ultimately excreted. As there can be potentially significant differences between patient drug absorption, metabolism and excretion, molecular testing allows a physician to work with a patient's individual phenotype and/or genotype to deliver an optimum pharmaceutical selection and/or dosage.

1. Beutler E. Iron storage disease: Facts, fiction and progress. Blood Cells Mol Dis. 2007;39:140-7.2. Higgins T, Beutler E, Doumas BT. Hemoglobin, iron, and bilirubin. In: Burtis CA, editor. Teitz Fundamentals of Clinical Chemistry. 6th ed. Saunders Elsevier, 2008.3. Ganz T. Hepcidin, a key regulator of iron metabolism and mediator of anemia and inflammation. Blood 2003;102(3):78-8.4. Andrews NC, Schmidt PJ. Iron homeostasis. Annu Rev Physiolo. 2007;69:69-85.5. Murtagh LJ, Whiley M, Wilson S, et al. Unsaturated iron binding capacity and transferrin saturation are equally reliable in detection of HFE hemochromatosis. Am J Gastroenterol. 2002;97(8):2093-9.6. Haddy TB, Castro OL, Rana SR. Hereditary hemochromatosis in children, adolescents, and young adults. Am J Pediatr Hematol Oncol 1988;10:23-4.7. Edwards CQ, Ajoika RS, Kushner JP. Hemochromatosis: A genetic definition. In Barton JC, Edwards CQ, eds. Hemochromatosis: Genetics, Pathophysiology, Diagnosis and Treatment. Cambridge, UK:Cambridge Univ Pr 2000:8-11.8. Whitlock EP, Garlitz BA, Harris EL , et al. Screening for Hereditary Hemochromatosis: A Systematic Review for the U.S. Preventive Services Task Force. Ann Intern Med. 2006; 145: 209-23.9. Wallace DF, Subramaniam VN. Non-HFE haemaochromatosis. World J Gastroenterol. 2007;13(35):4690-8.10. Tavill AS. Diagnosis and management of hemochromatosis. Hepatology. 2001;33:1321-811. Qaseem A, Aronson M, Fitterman N, Snow V, Weiss KB, Owens DK, et al. Screening for hereditary hemochromatosis: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2005;143:517-21.12. Phatak PD, Bonkovsky HL, and Kowdley KV. Hereditary Hemochromatosis: time for targeted screening. Ann Intern Med. 2008; 149(4): 270 – 2.13. Brissot P, deBels F. Current approaches to the management of hemochromatosis. Hematology Am Soc Hematol Educ Program. 2006:36-41. 14. Guidance for industry: Variances for blood collection from individuals with hereditary hemochromatosis. http://www.fda.gov/cber/gdlns/hemchrom.htm Accessed 12/17/08.

Michelle, a 19-year-old female, visited her gynecologist for her first pelvic examination and testing. She has been sexually active for three years. A liquid cytology specimen was collected for a Pap test.Result: Pap smear ASC-USThe office nurse who reviewed the report discussed with the physician an order for HPV DNA test on the saved liquid cytology specimen.

Debra is a 40-year-old female who has cervical cancer screening every three years. This visit's results: Pap smear NegativeHR-HPV DNA PositiveDebra is contacted by her physician to return in one year for repeat testing.

Bone marrow samples are obtained from the patient by a physician. The technologist is responsible for examining the sample macroscopically to ensure that it is adequate, making slides on the unanticoagulated sample and processing the remaining portions of the sample as required for procedures ordered.

The physician ordering the bone marrow is responsible for providing information about the procedure to the patient or parent or guardian, if the patient is a child. In order to reduce the patient's anxiety about the procedure, the physician may prescribe a mild sedative to be administered about an hour before the bone marrow is scheduled. The site is aseptically prepared by shaving, if necessary, washing with soap and water, applying antiseptic and draping the area with sterile towels. A local anesthetic, such as 2% xylocaine, is injected into the bone, penetrating the covering of the bone called the periosteum. Since a number of nerve endings are located near the surface of the bone, it is important to be sure that this area is anesthetized.

A 50-year old woman presented to her physician reporting increasing fatigue over the past several weeks. Routine blood tests were ordered. Her white blood cell count was elevated with a slightly abnormal absolute lymphocyte count. To evaluate the patient's lymphocytosis, a peripheral blood sample was submitted for flow cytometry.The following cytograms and histograms represent data from the blood sample that was analyzed using flow cytometry.

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.

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.

Insurance industry analysis of data from 1985 through 2003 shows that about two thirds of medical errors occur in hospitals and about one third occur in physician offices. About half of hospital errors occur in operating rooms and one sixth occur in patient rooms. Wherever medical errors occur, laboratory professionals can be involved.

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.

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. Do not attempt to guess what the order is. 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.

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.

An Advance Beneficiary Notice (ABN) is given to a Medicare beneficiary to inform him/her (or that person's representative) that Medicare may not provide coverage in a specific case (e.g., for a specific laboratory test). Entities who issue ABNs are known as "notifiers." "Notifiers" can include physicians, practitioners, laboratories, and other suppliers of services that are paid under Medicare Part B. The "notifier" (e.g., the laboratory) must complete the ABN and deliver the notice to the affected beneficiary or his/her representative before providing the items or services that are the subject of the notice. The ABN must be verbally reviewed with the beneficiary or his/her representative and any questions raised during that review must be answered before it is signed. The ABN must be delivered far enough in advance that the beneficiary or representative has time to consider the options and make an informed choice. Once all blanks are completed and the form is signed, a copy is given to the beneficiary or representative. In all cases, the notifier must retain the original notice on file. Note: ABNs are never required in emergency or urgent care situations.

ICD-9CM (International Classification of Disease, 9th Edition, Clinical Modification) codes are used for the classification of diseases and conditions, and for describing signs, symptoms and medical circumstances. These codes are used to indicate the medical necessity of a particular test. All employees who are directly or indirectly responsible for reporting to Medicare must be aware of these guidelines to prevent fraudulent claims:ICD-9 codes can only be supplied by the ordering physician or a representative of that physician. 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 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 laboratory cannot give free tests except in the event of laboratory error. The laboratory cannot give free education to clients unless it is about the laboratory's services or policies. The laboratory cannot give excessive or expensive gifts or entertainment to physicians. The laboratory can give discounts, but the price must be above cost and at "fair market value."

The laboratory must ensure that its sales and marketing materials are clear and not deceptive: They should fully inform the physician about the appropriate use of laboratory tests and services. They should not be designed to induce unnecessary testing. The laboratory must have in place a document control system and record retention policy that ensures records are accessible in case of an audit or investigation. Records should be retrievable. Related documents should be linked.

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.

LMRPs (Local Medical Review Policies) are published by Medicare for some laboratory tests. Developed for tests that can be used for screening or diagnosis of disease. CPT codes describe laboratory tests and ICD-9CM codes determine when coverage is allowed. If an LMRP test is ordered by a physician, an ICD-9CM code that is included in the LMRP must be given to the laboratory or the Medicare program will not pay for the test. It is against the law for laboratory to change or add an ICD-9 code submitted by a physician. The Balanced Budget Act of 1997 made it illegal for physicians to order LMRP tests and not supply an ICD-9CM code with the order.

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.

Notices to physicians must be sent by the laboratory to its customers once each year. Notices remind physicians about Medicare rules and regulations. Notices include summaries of laboratory test ordering policies, requisition use, CPT coding and ICD coding. Physician acknowledgements must be signed by any physician who wants to create a custom panel, profile or reflex test. This is the only way a special panel or profile may be performed by the laboratory. The physician must order tests individually when there is no physician acknowledgement signed. The laboratory must renew physician acknowledgements at least annually.

Laboratories may place phlebotomists or other employees in a physician office if all of the following are done: Employee only performs laboratory related tasks. There is a written understanding given to the physician about what the employee can and cannot do. Periodic audits are done to ensure the employee is following these policies. Laboratories may place printers, computers, fax machines or other equipment or products in client offices as long as they ensure that: The physician understands the equipment belongs to the laboratory. It is used for laboratory purposes like receiving reports or ordering tests. Periodic audits are done to ensure that the client is using the equipment only for laboratory related activities.

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.

LMRPs (Local Medical Review Policies) are published by Medicare for some laboratory tests. They are usually developed for tests that can be used for screening or diagnosis of disease. LMRPs use CPT codes to identify the tests and ICD-9 codes to determine when coverage is allowed. If an LMRP test is ordered by a physician, an ICD-9 code that is included in the LMRP must be given to the laboratory or the Medicare program will not pay for the test. It is against the law for laboratory to change or add an ICD-9 code submitted by a physician. A laboratory should not submit a claim for an LMRP test that is not accompanied by an acceptable ICD-9 code. The Balanced Budget Act of 1997 made it illegal for physicians to order LMRP tests and not supply an ICD-9CM code with the order.

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.

Do not leave test orders or test results in areas where they can be viewed by patients.Do not discuss test results or any patient information in areas where patients can overhear the conversation. Be careful not to discuss confidential information on the telephone where patients can overhear the conversation.Do not provide supplies to physician offices other than those usually provided by the laboratory. Document any supplies given to an office.Do not supply items that the office can use for testing (e.g. urine dipsticks). Do not allow offices to dispose of biohazard waste or sharps in the waste containers paid for by the laboratory.

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.

A courier is making a routine stop in a client's office and is approached by the office manager with whom he is very friendly because he has been going to this office for years. The office manager asks the courier if Dr. John Smith is a regular stop on his route and the courier answers yes. She then asks the courier if he would do her a little favor since he stops at Dr Smiths office regularly anyway and drop off an x-ray for her so she won't have to call a courier service. The courier knows that this is a big account for the laboratory and customer service is a high priority for the laboratory. This courier should:Correct Answer: Refuse to do it for the customer and explain to the customer that the laboratory has a policy that says he must only provide courier services related to laboratory.Discussion: Even though this is a single incident, by doing this favor the courier is giving the office manager license to ask these kinds of favors in the future. Since the provision of this free courier service is a form of inducement or kickback to the client, both the client and the laboratory would be involved if the such a practice were to go on regularly and be discovered by the government or by the laboratory. Hiding the incident and asking the office manager to conspire with him to do this will only make it worse for the employee and would lead to serious discipline action up to termination. The courier's best course of action, for the protection of his friend the office manager and himself, the physician practice and the laboratory is to not do this and explain the reason to the office manager so she is aware of the consequences of asking this favor.

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.

Direct contact with electrical current can cause sustained muscular contraction that may prevent the victim from releasing the electrical source. Shut off the electrical current if it can be done safely by unplugging the cord or turning off the main power switch. Merely turning off an instrument or appliance will not always stop the flow of electricity.If the current cannot be turned off, a non-conductive material such as a wood or plastic broom or chair, a rug, or a rubber mat can be used to push the victim away from the source of the current. Do NOT use a wet or metal object, and do NOT touch the victim with your bare hands. Verify that the object that is used does not have a metal core. As an extra precaution, stand on something dry and non-conducting such as a mat or stack of paper while attempting to free the victim from the electrical current. Call a physician immediately. Lower the victim's head to slightly lower than the trunk of the body, and elevate the legs. Cover the victim with a blanket or coat. Begin CPR if the victim's breathing and/or pulse has stopped or seems dangerously slow or shallow.

Depending on the exposure level at your workplace, you may need to complete a medical surveillance questionnaire before you begin to work with formaldehyde. This questionnaire helps determine your personal risk from exposure to formaldehyde. If your level of exposure is high enough, you may be required to complete this questionnaire annually. The questionnaire is reviewed by a licensed physician and may require a medical follow-up exam. The questionnaire and exam are given at no cost to you and remain confidential.

This questionnaire is reviewed by a licensed physician and may require a medical follow-up exam.Both the questionnaire and exam are given at no cost to you and remain confidential.

In order to discuss TDM and PGx we need to also introduce the concept of pharmacokinetics. Pharmacokinetics is the study of drug disposition in the body: how and when drugs enter the circulation, how long they remain in the blood, and how they are eliminated. TDM is the clinical assessment of a drug's pharmacokinetic properties. Physicians and pharmacists need to establish that a drug is present at an effective concentration but not at a toxic concentration. The next few pages will describe some of the factors that determine a drug's disposition in the body. These factors ultimately decide the need for therapeutic drug monitoring.

TDM provides a quantitative measure of the circulating concentration of a drug. The physician determines if the dosage of the drug needs to be adjusted based on this information.If a drug concentration is determined to be outside the therapeutic range, it may be for one of the reasons listed in the table below. Reason Discussion Noncompliance Patients may (intentionally or unintentionally) not take the drug. TDM can thus help monitor compliance. Dosing errors The dose may have been erroneous or inappropriate given the patient's condition. Malabsorption The TDM result will reveal if the drug cannot be absorbed well through the gut and an alternative route of administration will be needed. Drug interactions Many drugs interfere with the absorption or metabolism of other drugs. These interactions will be revealed by TDM. Kidney or liver disease Any pathology that affects elimination will cause an elevation in a drug level that will be unmasked by TDM. Altered protein binding Changes in serum proteins can lead to big changes in the amount of free drug in serum. Variations in the genetics of drug-metabolizing enzymes can also affect drug concentrations in the body. This is the field of pharmacogenomics that will be discussed later in the course.

The ultimate goal in measuring CYP450 function or identifying polymorphisms is to predict effective therapeutic doses and responses in patients.Polymorphisms are identified using molecular techniques (allele-specific PCR, restriction digests, sequencing, hybridization assays, bead-based systems, microarrays, pyrosequencing, et al).Although most clinical labs do not offer PGx testing, reference labs are beginning to market these tests. For example, one reference laboratory in the Midwest that offers CYP2D6 profiling measures about one dozen of the most common and significant mutation sites on this enzyme. This allows for detection of approximately 98% of the known CYP2D6 polymorphisms. The laboratory then generates a report which will advise the physician on the patient's drug-metabolizing status.Estimates show that 6-10% of the general population have a complete deficiency of CYP2D6, with the prevalence of mutations varying from <1% to as much as 21% within a given population.

The first specific pharmacogenomics (PGx) testing application most labs are likely to encounter is that used in patients taking warfarin. Recent studies have revealed that the variations seen in patients taking the anticoagulant warfarin are due to PGx factors. The consequences of incorrect warfarin dosing are obviously serious, with inadequate doses predisposing patients to thrombosis and higher doses placing them at risk for hemorrhage. The United States' Food and Drug Administration (FDA) recently approved updated labeling for Coumadin (warfarin sold by Bristol-Myers Squibb). The new labeling suggests that physicians incorporate PGx information into warfarin-dosing regimens for patients. Manufacturers of generic warfarin products are now adding similar labeling.

Bobby Jones, a phlebotomist at Georgetown Hospital, entered the room of Mrs. Mary Grayson with a physician's order to draw some blood work. After properly greeting Mrs. Grayson, identifying himself and checking her armband, Bobby prepared for the venipuncture. He suddenly notice a sign posted above the bed that read: "Restricted left arm usage. Previous mastectomy - Do no use left arm for venipuncture." Bobby set up his equipment to use her right arm and noticed an IV line in Mrs. Grayson's right arm positioned in a vein slightly above her wrist on the dorsum (top) of her forearm.

This phlebotomist violated hospital procedures in several ways that could adversely impact patient care: Cleaning the site only with alcohol, not iodine, could result in a false-positive contaminated blood culture. This might result in the patient receiving unnecessary intravenous antibiotics, and could prolong the patients hospital stay unnecessarily. Drawing both cultures at the same time lessens the chance of recovering a bloodstream organism.Drawing both cultures from the same site might result in both of them being contaminated, making it very difficult for the physician to distinguish contamination from a "real" bloodstream infection.Relevant topics:Blood cultures: introduction, Avoid skin contamination, Blood culture site preparation 1, Blood culture site preparation 2

If someone hesitates to let you collect a blood specimen, explain to them that their blood test results are important to their care. However, patients have a right to refuse blood tests. If the patient still refuses, report this to the nurse or physician, and document patient refusal according to your hospital's policies and procedures.

The work flow of any medical laboratory involves these basic steps: Physician orders lab tests. Order is received in lab. Work list and labels generated by lab. Phlebotomist is dispatched to patient.

Phlebotomists are ethically and legally required to keep patient information confidential. Reveal patient information including medical history and results only to authorized individuals as defined by your laboratory's policies & procedures. Do not discuss test results with patients without a written order from the ordering physician.

Physicians need to know the blood concentration of certain drugs in order to select the best dose for their patients.As a phlebotomist, you might be asked to draw peak (highest), and trough (lowest) levels of various therapeutic drugs.

Cultures often require 24 or more hours before a pathogen can be recovered. A Gram stain can give preliminary information about the type of bacterial and/or fungal organisms that are present. A rapid diagnosis of bacterial meningitis, made after examining a gram-stained smear of the patient's cerebrospinal fluid, allows the physician to begin treatment immediately. Intracellular gram-negative diplococci observed in a male urethral specimen may be confirmatory of the diagnosis of gonorrhea. Cultures may not even be needed unless susceptibilities are required. (In the female genital specimen, the presence of gram-negative diplococci is not specific enough to confirm the diagnosis, and a culture or other confirmatory testing must be performed).

Gram stain is used primarily as a differential stain for bacteria, although it will also stain most fungi (especially yeasts) and some parasites, including Strongyloides and Trichomonas. The Gram stain procedure is commonly performed on direct smears of clinical samples and on smears from cultures. This course will focus on Gram stained direct smears. A direct smear is made from a clinical specimen. It can be used to: Guide the physician on initial choice of antibiotic, pending results of culture and sensitivity. Judge specimen quality. Contribute to selection of culture media, especially with mixed flora. Provide internal quality control when direct smear results are compared to culture results.

Identification of bacteria in direct smears may be of lifesaving importance. For example, a rapid diagnosis of bacterial meningitis, made after examining a gram-stained smear of the patient's cerebrospinal fluid, allows the physician to begin treatment immediately. The appearance of bacteria on gram-stained smears is suggestive of a certain species, but identification may not be made on the basis of the stain alone. An exception to this rule is the presence of gram-negative intracellular diplococci from a male urogenital specimen, which is presumptive identification of Neisseria gonorrhoeae. In addition, culture results can be correlated with the direct smear report.

It is important to note the Gram stain reaction, shape, and cellular arrangement when examining culture smears. This information may be useful in making a presumptive identification. The following nine screens contain ungraded practice questions covering the material that has been covered so far.

Glassy, Eric F.,(Ed). Color Atlas of Hematology: An Illustrated Field Guide Based on Proficiency Testing. 1998. College of American Pathologists Hematology and Cliical Microbiology Research Committee. College of American Pathologists, Northfield, IL 60093-2750.Hookey,L., Dexter, D., Lee,D. H. The Use and Interpretation Of Quantative Terminology In Reporting Red Blood Cell Morphology. Laboratory Hematology 7:85-88, 2001.Peterson P, Blomberg DJ, Rabinovitch A, Cornbleet PJ. Physician Review of the Peripheral Blood Smear: When and Why. For the Hematology and Clinical Microscopy Resource Committee of the College of American Pathologists. Laboratory Hematology 7:175-179, 2001

After an automated complete blood count (CBC) analysis has determined that abnormal RBC morphology may be present, a well-made and well-stained peripheral blood smear should be prepared. When a peripheral blood smear is made for the purpose of evaluating RBC morphology, accurate recognition and identification of RBC morphologic abnormalities can be an invaluable aid in the diagnosis of a variety of disorders. It is important to understand that red blood cell morphology report formats tend to vary widely among laboratories. Despite the standardization of many laboratory technologies and test result formats, there are still various protocols in use in the area of red cell morphology reporting. Current methods of reporting and quantifying red cell morphology include descriptive terms such as 'rare,' 'occasional,' 'many,' 'slight,' or 'moderate,' as well as numerical gradings of 1+, 2+, 3+, etc. Regardless of the terminology used, consistency is of greater importance. There must be a defined, semi-quantitative scheme that dictates how many cells with a specific morphologic abnormality qualify as "rare" or "many," and so on. The report format must be clear and useful to the physician. Some morphologic abnormalities are quite specific and diagnostic, but others are ambiguous and of little diagnostic significance.A well-defined, semi-quantitative report format for RBC morphology should be based on clinical significance. Some morphologic abnormalities are significant, even when they occur in very low numbers. These include:SchistocytesSickle cellsAcanthocytesSpherocytesTeardrop cellsPolychromatophilic cells Other morphologic abnormalities are significant only when seen in considerable numbers. These include:MacrocytesMicrocytesOvalocytesBurr cells (echinocytes)Target cellsStomatocytesHypochromic cells A final category includes morphologic abnormalities that do not need to be quantified as it serves no purpose; these findings can be noted as "present." These include RBC agglutinationRouleauxDimorphic or double red cell populationAn example of a standardized reporting format is given on the following page.

Recognition and identification of RBC morphologic abnormalites can be an invaluable aid in the diagnosis of a variety of disorders. Observation of RBC morphology from a properly prepared smear will also confirm the red cell indices reported by the hematology analyzer.RBC morphology can be visualized by examining erythrocytes on a Wright, or Wright-Giemsa stained peripheral blood smear. Evaluation of red cell morphology involves differentiating normal morphology from abnormal and artifactual morphology.

It is important to differentiate in vitro changes, which are secondary to preparing the slide, from in vivo morphology, which is the result of the pathophysiological condition of the patient. Examining erythrocytes in the critical viewing area is extremely important in making this distinction. The determination of the clinical significance of the morphology reported is the responsibility of the physician, who must correlate the blood smear findings with other laboratory parameters and with the clinical picture.

Patient A.D., a 30 year old female, was admitted to the hospital in active labor to deliver at 37 weeks gestation. Transfusion service (TS) records showed A.D. to be group O Rh negative with no record of unexpected red cell antibodies.Maternal history showed two prior pregnancies. Her first pregnancy four years ago ended in spontaneous abortion at 9 weeks gestation and she received a mini-dose (50 µg) of RhIg.In the second pregnancy, two years ago, the infant typed as Group A Rh positive, DAT negative. Patient A.D. was injected with RhIg within 72 hours of delivery. The laboratory also confirmed that in the current pregnancy RhIg was administered at approximately 28 weeks gestation subsequent to a negative antibody screen.After many hours of non-productive labor, the physician considered that labor had stalled and decided to do a cesarian section (C-section). According to hospital policy for C-sections, a type and screen was ordered.

Numerous studies have shown that, if administered correctly, RhIg is effective at preventing D immunization. To work, RhIg must be given in sufficient dose, and it must be given before Rh immunization has begun.Unfortunately, despite RhIg's proven efficacy, some women still make anti-D in the perinatal period. Such 'failures' are mainly (but not totally) due to human error. Examples of how women may still produce anti-D some 40+ years after the implementation of RhIg prophylaxis: Immunization to D occurred before RhIg was administered, e.g., before 28 weeks gestation*; Immunization to D occurred after the administration of RhIg at 28 weeks and before delivery because an antenatal FMH occurred that was too large for residual passive anti-D to give protection; Female was already immunized from a prior pregnancy but anti-D was too weak to be detected in antibody screen tests prior to RhIg administration; RhIg dosage was insufficient to clear a larger fetal bleed at delivery (e.g., FMH screen or quantification was not done or a false negative occurred); Incorrect calculation of RhIg dosage; RhIg administered too late , e.g., well after 72 hours of delivery; Antenatal RhIg not given, e.g., mother had no or limited access to prenatal care, or did not seek it, and a FMH occurred during pregnancy; Failure of physician to carry out prenatal blood testing; RhIg not given due to laboratory clerical or technical error in Rh typing the mother or child; RhIg not given in cases such as abortions, ectopic pregnancies, and trauma (e.g., car accidents). * Because anti-D production before 28 weeks is rare (the order of 0.24% to 0.31%), RhIg's use earlier in pregnancy is not recommended. It is not cost effective and would expose most women to an unneeded blood product.

Recently, significant attention has been focused on errors made during the postanalytic phase of laboratory testing and the impact errors made during this phase have on laboratory-related patient outcomes. Similar to the preanalytic phase, the postanalytic phase can be subdivided into those procedures that are within the laboratory, and those outside the laboratory; where the physician receives, interprets, and acts on the laboratory results. The examples listed below are limited to possible postanalytic errors that may occur within the laboratory and over which the laboratory has more control: Laboratory results not verified before being reported. Improper data entry or typing mistakes causing erroneous information to be reported. Critical values not reported, or not reported in a timely manner. Laboratory tests not reported or reported to the wrong health provider.(For example, poor communication to a patient's physician of the results of laboratory tests that are pending at the time of a patient's discharge.) Lack of timeliness of reporting laboratory results (slow turnaround time). Misinterpretation of an alphabetic flag in the result field (i.e. lower case "l" interpreted as the number "1". Oral results misunderstood by receiving party- no "read back" requested to confirm that data was correctly received.

During a blood collection, bacteria that is present on the skin surface may adhere to the outside of the needle as it enters into the vein. This can allow bacteria to infect the puncture site. A serious infection of the blood (septicemia) or of the tissue (cellulitis) may result. To avoid an infection, it is imperative that the phlebotomist uses a technique that thoroughly cleanses the skin at the site prior to venipuncture.Once the phlebotomist locates a suitable vein for venipuncture, the site of the vein that will be punctured is cleaned with a pre-packaged wipe saturated with 70% isopropyl alcohol.The site is cleansed using a "target" motion beginning at the center of the site and moving outward in concentric circles applying enough pressure to move surface bacteria away from the puncture point. (This is demonstrated in the image on the right). It is not recommended to use a scrubbing back and forth motion to clean the site since you may drag bacteria from a dirty area back into the clean area. Allow alcohol to air dry for effective disinfection of the site. Never use non-sterile gauze to wipe dry the alcohol as this will contaminate the site.During the remainder of the procedure, the site must NOT be touched by anything that has not been cleaned in an identical manner. The phlebotomist should avoid retouching the site after cleaning. If it is absolutely necessary to re-palpate, the phlebotomist MUST clean the gloved finger in a manner identical to the above procedure. Make certain that no other piece of equipment touches the site. This includes ends of the tourniquet and gauze. If you suspect that your needle has touched the site before entry, dispose of the needle, re-clean the site and repeat the procedure using a new needle. If a patient complains that there is redness or pain at the puncture site, even hours or days after the procedure, immediately refer the patient to his/her physician for evaluation.

Case study:You work in a large hospital that specializes in pediatrics. The policy of the facility is to encourage the parent or guardian to remain in the room during venipuncture to comfort the child. You have taken steps to prepare the child for the venipuncture, but the child starts to cry and becomes combative. The mother says that she does not want the test done.Suggested plan of action: Do not proceed if the mother has refused the blood collection for her child. The patient's physician or clinical person in charge of the patient should be contacted and informed of the situation. This may not be something that you would do directly. It may be your facility's policy for you to contact your supervisor.

Mr. R.M., a 55-year old male, was admitted to a hospital emergency department with severe lower gastrointestinal bleeding. His history revealed multiple prior transfusions, the last of which he received five years earlier.Physical examination revealed hemodynamic instability (systolic BP 60 mmHg). Blood tests revealed a hemoglobin (Hb) of 8 g/dL (80 g/L) and a hematocrit (HCT) of 28% (0.28). The patient received aggressive fluid resuscitation with Ringer's lactate and was sent to the operating room (OR) for an emergency laparotomy.The physician ordered four units of Red Blood Cells to be crossmatched.Two units of uncrossmatched group O Rh-negative Red Blood Cells were also ordered and authorized for immediate emergency transfusion.

If the physician had decided to continue transfusing the patient at this stage, the following information should be communicated: Although all donors appear to be compatible in the post-transfusion crossmatch, they are not. The results are false negatives - the patient's antibody has been "mopped up" by adsorbing to the incompatible transfused O Rh-negative RBC. Given that 6 donors were positive using the pretransfusion plasma, the antigen is a higher frequency antigen and most donors would likely be antigen-positive and incompatible. The patient's physician should consult the TS medical director before any decision to transfuse is made. Transfusing RBC before tests are complete requires physicians to sign an emergency release form in which they assume full responsibility.

According to the CDC guidelines, patients with clinical illness consistent with uncomplicated influenza who reside in an area where influenza viruses are circulating may not require diagnostic influenza testing for clinical management. Most mild cases of H1N1 infection are self-limiting and do not require confirmation. However, if a patient is hospitalized due to the severity of the symptoms, or if the diagnosis of the patient will provide needed information to the physician to direct clinical care, infection control decisions, or management of close contacts, diagnostic influenza testing should be done. In any case, if a decision to use antiviral treatment is made, the treatment should commence as soon as possible, without waiting for the results of confirmatory diagnostic tests.

When vaccine first became available to protect against infection with H1N1 virus, supplies were limited and those who were in high risk groups were given priority for receiving the vaccine. However, as of late December 2009, supplies increased substantially so that sufficient vaccine was available for everyone who chose to receive it. The CDC recommends that all individuals, regardless of age or health status, receive the vaccine. Individuals, age 65 or older with no medical risk factors, are less likely to get sick with H1N1, however, severe illness and deaths have occurred in all age groups. Therefore, it is prudent for everyone to be vaccinated. The vaccine is produced in the same manner as the vaccine against seasonal influenza and has the same assurance of safety that has been proven with the seasonal influenza vaccine. One caution that should be noted is that persons with known allergies to eggs may experience allergic reactions to the H1N1 vaccine, as they would with any influenza vaccine. These individuals should consult with a physician before receiving the vaccine.

In order for a urinalysis to be useful a physician must know not only what elements are present but the quantity of each. This section will deal with counting and estimating the microscopic elements found in the urine sediment. The quantifications may vary slightly between laboratories, but each lab should have its own criteria. Quantitation may be divided into three steps: Looking for casts Counting elements Estimating elements

When the laboratory receives notification of a transfusion reaction, the first step is a clerical check. The clerical check should be performed as soon as possible to identify any possible ABO incompatibility. The technologist will compare the component bag, label, paperwork, and patient sample and look for errors. If an error is found, the physician must be notified. Once the post-transfusion sample is received, the sample should be examined for the presence of hemolysis. Both the pre-transfusion sample and post-transfusion sample can be compared. Destruction of red cells and release of free hemoglobin will result in a pink to red supernatant. Pink or red colored serum may indicate intravascular hemolysis. The patient's serum may appear icteric if the hemolytic process is extravascular. The ABO testing must be repeated on the post-transfusion specimen as well. Examination of a post-reaction urine sample made aid in the diagnosis of acute hemolysis. Free hemoglobin in the urine indicates intravascular hemolysis. A direct antiglobulin test (DAT) must be performed on the post-transfusion sample. An EDTA lavender top tube is the required specimen type. If the DAT is positive on the post-transfusion sample, then one should be performed on the pre-transfusion sample. If the pre-transfusion DAT is negative and the post-transfusion is positive, the presence of incompatible red cells should be suspected. All findings must be reported to the supervisor or medical director, who may request additional tests.

Adverse reactions after transfusion of blood components must be evaluated promptly. Most serious reactions occur within the first 15 minutes of starting a transfusion. Continuous monitoring allows reactions to be discovered in a timely manner. The transfusionist must be able to recognize the symptoms of a transfusion reaction and know the appropriate steps to take when one occurs. The first critical step is to stop the transfusion immediately, but keep the patient's line open with saline. The physician should be contacted immediately for instructions regarding patient care. The transfusion service must be notified of the reaction. They will usually provide instructions on proper documentation of the reaction, and the return of any remaining component and/or tubing. The appropriate patient samples are to be sent to the laboratory and usually include blood and urine. The transfusionist must be sure to follow all hospital policies.

The symptom most commonly associated with a delayed hemolytic transfusion reaction (DHTR) is unexplained decrease in hemoglobin and hematocrit. Patients may also present with fever and jaundice. Hemolysis occurs slowly and is primarily extravascular. Unlike an acute hemolytic transfusion reaction (AHTR), hemoglobinuria, acute renal failure, and disseminated intravascular coagulation (DIC) are not generally seen. On some occasions, patient's may not present with any symptoms. Serologic findings include a positive direct antiglobulin test (DAT) and/or a positive antibody screen in post-transfusion testing. In many cases, the physician will send a request for an additional transfusion because of the decreased hemoglobin levels, and not suspect a DHTR. The positive antibody screen will trigger an investigation including antibody identification. The DAT may have a mixed field appearance because of the antibody-sensitized transfused red cells and the non-sensitized patient red cells. Segments from the donor unit can be tested for the offending antigen once the antibody has been identified.Antibodies that are most often reported as the cause of DHTR are anti-Jka and anti- Jkb. Other antibodies that are also commonly implicated in a DHTR include Kell, Rh, and Duffy system antibodies.The patient's physician should be notified so that additional clinical and laboratory evidence can be evaluated.

Symptoms of TB can mimic other diseases and the physician must consider the patient's history as well as physical symptoms before making a final diagnosis.

Respirators are used in situations that pose a high-risk for exposure to infectious aerosols. The most commonly used respirator in the health care facility is the N95 respirator, shown in the image on the right. An N95 respirator should be used when collecting specimens from patients with known or suspected cases of active tuberculosis. In a microbiology laboratory, a respirator should be used when it is probable that aerosols might be released in the biosafety cabinet at substantial levels as a result of the manipulation of the potentially infectious specimen. Health care workers (HCW) are screened for medical conditions by a physician prior to using respiratory protection.Annual fit-testing and training on proper usage of the N95 respirator is required. Fit testing ensures a good face seal can be achieved. Each time the respirator is worn, the wearer performs a user-seal check to ensure adequate respiratory protection. HCW who, for medical reasons, cannot use N95 respirators and men with beards or other facial hair that would interfere with the seal between the face and the respirator must use a different type of respirator that offers sufficient aerosol protection but does not require fit-testing. However, annual training on proper usage is required.

Smudge cells are remnants of cells that lack any identifiable cytoplasmic membrane or nuclear structure. Smudge cells, also called basket cells, are most often associated with abnormally fragile lymphocytes in disorders such as chronic lymphocytic leukemia (CLL). However, they can also be seen in degenerating samples; in which case, their origin may not be lymphocytic. Smudge cells are indicated by the arrows in this image. In some laboratories, a semi-quantitative estimate of the number of smudge cells may be made; in others, a report of "smudge cells present" may suffice. This reporting scheme must be understood by the physician in order to maximize patient care outcomes through his/her decision making process. For example, in the context of this exercise, does it make any difference to the physician if you report few or many smudge cells; or, is a report of smudge cells present sufficient? The answer to this question applies not only to smudge cells, but to the reporting of any other atypical white cells as well. An agreement must be reached between the hematology laboratory and clinical services as to how semi-quantitative estimates will impact the need for further testing in view of patient care outcomes.

In 1952 Dr. Chediak reported a childhood disorder in which abnormal cytoplasmic inclusions appeared in the neutrophils of four family members. In 1954 Higashi reported a similar abnormality in an 11-month old Japanese infant. These inclusions were identified as lysosomal in origin and found in this rare autosomal recessive disorder. Death in patients afflicted with this condition was usually related to recurrent infections or hemorrhage. Ocular and cutaneous albinism, increased susceptibility to pyogenic infections, abnormal granules in neutrophils, and a bleeding tendency are all prominent findings in Chediak-Higashi anomaly. Notice the striking neutrophilic inclusions which appear as coarse intra-cytoplasmic azurophilic granules(indicated by the arrows in the images on the right). These granules arise from dilated portions of the Golgi-endoplasmic reticulum lysosomal apparatus.

A 14-year-old boy came to the physician's office with a sore throat that progressively worsened over a three-day period. His posterior pharynx was swollen, shiny and erythematous. The boy complained of pain on swallowing. His temperature was 98.5°F. A rapid direct streptococcal antigen test was positive. However, his symptoms did not subside over the next two days while on antibiotic therapy. Anorexia and nausea were persistent and compounded by a frontal headache. Cervical lymph nodes became noticeably enlarged. A complete blood count (CBC) was ordered. The results of the CBC were: WBC 11.9 x 109/L ( Reference interval= 3.8 - 9.8 x 109/L) with: 17% segmented neutrophils 5% band neutrophils 72% lymphocytes 6% monocytes All red cell findings were normal. The automated differential flagged for atypical cells, presumptively atypical lymphocytes. A peripheral blood smear was prepared. The image on the right is a representative field from the Wright-Giemsa stained smear (1000X magnification).A rapid qualitative test for infectious mononucleosis was positive. This is a case of group-A streptococcal infection superimposed on infectious mononucleosis. Symptoms subsided in three weeks following completion of the antibiotic therapy.