| Case A 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%) | View Page |
| Case C A 55-year-old female is seen for a routine physicial. She has gained 20 pounds since her last physical two years ago, which she attributes to lack of exercise and a high-fat diet. She also reports increased stress in her life because of work and additional responsibility of caring for her elderly father. Suspecting that the patient has developed diabetes, her physician orders a Hb A1C test, which is repeated two weeks later. Initial Hb A1C = 6.8% (Reference interval 4 - 6%)Repeat Hb A1C (two weeks later)= 6.7% (4 - 6%) | View Page |
| Case A (continued)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 HbA1C the following week.Laboratory results:Fasting plasma glucose (FPG)= 110 mg/dL (Reference interval 75 - 100 mg/dL)One Week Later:HbA1C= 6.0% (Reference interval 4 - 6%)Which of the following statements is most accurate regarding the patient in Case A? | View Page |
| Clinical Testing A large number of assays related to carbohydrate management and diabetes monitoring are performed in clinical laboratories, hospital nursing units, nursing homes, physician offices, clinics, and by patients at home, school, or work.Assays that will be discussed are: Blood Glucose Urine Glucose Ketones Microalbuminuria Insulin and C-Peptide Insulin Antibodies Glycosylated Proteins | View Page |
| Urine Glucose 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. | View Page |
| The Laboratory's Role in Diagnosis and Monitoring of Diabetes Even though most diabetics, physician offices, clinics, nursing homes, and nursing units use glucose meters for monitoring glucose levels, the laboratory's role in diagnosis is vital. The function of the laboratory is crucial in diagnosis, monitoring, and management of diabetes. Diabetic patients can go into severe metabolic imbalances that are life threatening. These metabolic conditions include: diabetic ketoacidosis, hyperosmolar nonketotic coma, and hypoglycemia. Laboratory testing is essential in diagnosing and monitoring these conditions.Laboratory blood glucose and HbA1C levels are used to demonstrate the level of hyperglycemia required for diagnosis. If an OGTT is needed for classification or characterization of hyperglycemia, a patient is sent to a hospital or clinical laboratory for the test. Detection of elevated microalbumin levels that can signal early stages of renal impairment is accomplished through laboratory testing. There are many other disease states and complications associated with diabetes. Clinical laboratories detect these diseases and monitor the complications that result. Important among these assays are urea, creatinine, and serum lipids. If a diabetic does have a pancreatic transplant, serum C-peptide and insulins levels monitor transplant success and viability of transplanted organ. | View Page |
| An Rh negative pregnant female has produced anti-D and the physician has decided to use molecular typing to determine if the fetus is at risk. Is the following statement true or false?If molecular genotyping demonstrates that the father is homozygous for the RHD allele, molecular typing of the fetus is also indicated. | View Page |
| RhIg 'Failures' 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 continue to 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 the administration of RhIg, e.g., before 28 weeks gestation*; Immunization to D occurred after the administration of RhIg at 28 weeks and before delivery because an antenatal fetomaternal hemorrhage (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 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. | View Page |
| References 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. | View Page |
| Transferrin Saturation Transferrin saturation (TS) is usually reported along with the serum iron (SI) and total iron binding capacity (TIBC). TS indicates the percent of iron binding sites on transferrin that are carrying iron. TS is derived from a calculation using the formula:TS =(SI/TIBC) x 100TS results are reported as percentages. Typical reference intervals for TS are 20% to 55% for males and 15% to 50% for females. TS is currently considered to be a good test for screening persons for hereditary hemochromatosis (HH) due to its sensitivity and specificity for iron overload. It may be elevated prior to significant deposition of tissue iron. TS levels increase as additional iron is accumulated.A drawback to using the TS is that it is dependent on performing both the SI and TIBC. The unsaturated iron-binding capacity UIBC may be a lower cost alternative.The optimal TS criterion for detecting HH is controversial. Using a TS of >60% for males and >50% for females has been found highly accurate in detecting abnormal iron metabolism in persons with HH. Others studies suggest using lower TS levels, e.g. 45%, as a criterion indicating further testing is warranted. Current guidelines from the American College of Physicians include a TS cutoff level of >55% for identifying iron overload. (11)Patients with initially increased TS should be followed by performing a second TS from a fasting morning specimen. The patient should also be advised not to take vitamins supplemented with iron or oral contraceptives for several days prior to the repeated test. TS levels may be affected by diurnal variation, dietary factors, and co-existing disease states such as inflammation and hepatitis. Patients with HH may have falsely normal TS if chronic blood loss or inflammatory disease is present. | View Page |
| What is the American College of Physicians' recommended criterion level for transferrin saturation when testing for hereditary hemochromatosis (HH)? | View Page |
| Maintenance Therapy Lifelong treatment of hereditary hemochromatosis (HH) is needed to keep iron at low levels. Without regular treatment, iron stores will re-accumulate. The primary care physician may manage patient care during long-term maintenance. Long-term maintenance typically consists of removal of an average of 2 to 6 units of whole blood yearly, although this number is variable. Monitoring of hemoglobin and serum ferritin levels determine the frequency of phlebotomy. Serum ferritin levels should be maintained at concentrations of no more than 50 ng/mL. (10,13)) | View Page |
| Director Qualifications Effective date March 17, 2008All applicants for a Director license must meet the qualifications for a high complexity laboratory director that are defined in 42 CFR 493.1443 as published on October 1, 2007.A licensed physician may direct a clinical laboratory without a separate laboratory director's license if he / she is certified in clinical pathology by the American Board of Pathology (ABP) or the American Osteopathic Board of Pathology (AOBP); is board-certified in the pertinent laboratory speciality; and/or has four years of pertinent clinical laboratory experience (post-graduate) with two years experience in the speciality that will he/she will direct.A non-physician may obtain a director's license for a specialty area if he / she: Holds an earned doctoral degree in a chemical, biological, or clinical laboratory science Is certified in the pertinent laboratory specialty by an approved national board A director can oversee up to five laboratories. | View Page |
| Description of Specialties (3) Specialists in radioassay use radionuclides to determine the chemical makeup of body fluids such as blood and urine.
Specialists in blood gas analysis evaluate lung and breathing function by levels of oxygen, carbon dioxide, pH, and hemoglobin with automated tests.
Specialists in histology examine cellular and tissue samples using fixation, dehydration, embedding, microtomy, frozen sectioning, staining, and other similar techniques. Histology specialists licensed as technicians can perform specimen processing, embedding, cutting, staining, and frozen sectioning only under the general supervision of a director, supervisor, or technologist.
Specialists in cytology process and interpret samples relating cytopathological disease. Non-gynecological cytology preparations can be screen by a specialist in cytology but final review and interpretation must be done by a physician. | View Page |
| Kickback and Inducement Violations 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. | View Page |
| Rules Violations Clinical laboratory personnel are extremely important in patient care. Physicians and patients must trust that all reports and test results provided by clinical laboratory personnel were obtained by competent, licensed individuals who are free from bias.
The Board of Clinical Laboratory Science has strict rules regarding clinical laboratory personnel. A violation of these rules can result in fines, suspension, or even criminal and civil legal penalties. Please pay carefully attention to the next several pages, which cover these violations. | View Page |
| Test Requisitions 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. | View Page |
| Issues Related to Test Ordering, Performance, and Resulting The laboratory can only perform tests that are ordered by individuals authorized to order tests. If an employee knows that a test has been ordered by someone other then an authorized individual, the employee should report it to their supervisor or the compliance officer (CO). The laboratory must have a system in place to detect tests that are not performed due to a laboratory error and stop or credit the billing for these tests. The laboratory cannot bill for tests that are not performed. An employee who is aware that a test has been canceled or has not been performed for some reason must follow the policies and procedures associated with correcting the billing. Release of test results Laboratory employees should release test results only to a person who is authorized to receive the test results. The Clinical Laboratory Improvement Amendments (CLIA) define an authorized person as: "an individual authorized under State law to order tests or receive test results, or both." Patients may be considered "authorized persons," if State law defines them as such. Refer to your own State laws regarding release of laboratory results directly to patients. | View Page |
| 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. 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. | View Page |
| Physician Notices and Acknowledgements Notices must be sent annually by the laboratory to its customers (physicians). 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. | View Page |
| Case Study 3 It is 11:00 PM and the specimen processing department is finishing up the night's accessioning and test order entry. A specimen processor is working on a requisition that has an order for a Hepatic Profile but there are two tubes of blood with the order, one of which is a lavender top tube. This is the fourth requisition from this same doctor's office and all of them have had a lavender top tube and serum tube with an order for a chemistry test and a CBC. No CBC is marked on the requisition or written on the tube. The specimen processor figures the office just forgot to mark the test and knows that the results will be delayed and the sample might not be any good if he doesn't order the CBC now. He is also under pressure from the technical departments to finish processing on time so they can get their work done on time for result printing in the morning. What should the processor do?Correct Answer: Look up the laboratory's policy for handling such a situation and follow the policy.Discussion: The laboratory is not permitted to change a doctor's order in any way. By ordering the CBC the processor is ordering a test that the doctor did not specifically order and therefore makes the laboratory subject to a violation of the False Claims Act. By reviewing and following the laboratory policy the processor assures that the laboratory, the physician and the patient's best interests are met. | View Page |
| Case Study 4 A busy laboratory is located in a 350 bed urban hospital that provides laboratory testing for the hospital and for the hospital's outreach testing program. A medical technologist in the microbiology department receives a call from a friend who works in a laboratory in a physician office. The physician is not a regular client of the laboratory currently but uses another laboratory for most of their work. The microbiologist knows that the sales department would like to get this account. The friend explains to her that she is doing a quality control check on her in-office microbiology testing and her regular laboratory will do it but is going to charge her for it. She asks the microbiologist if she will do it for free since it is quality control, not Medicare, and is not going to be billed to anyone.She tells the microbiologist that she would like to use the hospital lab for everything but her doctor insists on using the competitor. She indicates that the favor might help get the doctor to try the hospital laboratory for other tests. How should the microbiologist respond to this request?Correct Answer: Explain to her friend that if the hospital does the tests for no charge on the promise of other referrals, both the physician office and the hospital could be liable for violations of the antikickback statute.Discussion: The antikickback statute is implicated in this scenario because the free testing is solicited on the condition that other referrals may occur as a result of providing the favor. In fact, the solicitation itself is a violation of the law. The fact that Medicare patients are not specifically mentioned in the scenario is not sufficient to remove the risk. The technologist should also report the incident to the Compliance Officer and seek advise about what documentation, if any, should be kept concerning the incident. | View Page |
| Advance Beneficiary Notice (ABN) 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. | View Page |
| Changes to ABN, Effective March 1, 2009 Beginning March 1, 2009, providers (including independent laboratories), physicians, practitioners, and suppliers are required to use a newly revised ABN form --Form CMS-R-131-- for all situations where Medicare payment is expected to be denied. The revised ABN replaces the existing General Use ABN, ABN-G (Form CMS-R-131G), and the Laboratory ABN, ABN-L (Form CMS-R-131L), and NEMB (Form CMS-20007). An example of the new form is included on this page as a resource. The revised form will continue to be used for notifying beneficiaries of Medicare denial reasons, but it may also be used to provide voluntary notification of financial liability. The revised ABN still permits pre-printing of lab-specific key information (blanks A - D) and still permits the use of the same denial reasons that were used with the former ABN-L (Blank E). Three commonly used reasons for noncoverage are: Medicare does not pay for this test for your condition. Medicare does not pay for this test as often as this (denied as too frequent). Medicare does not pay for experimental or research use tests. There must be at least one reason applicable to each item or service listed in Blank (D). The same reason for noncoverage may be applied to multiple items in Blank (D). | View Page |
| ICD-9CM Coding 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. | View Page |
| Local medical review policies (LMRPs) Local Medical Review Policies (LMRPs) 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 a 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. | View Page |
| Inducements 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." | View Page |
| Phlebotomists and Equipment in Client Offices 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. | View Page |
| Marketing and Record Retention 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. | View Page |
| Utilization and Other Regulations 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 Hospital 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. | View Page |
| Laboratory Billing Department Communication With Physicians and Patients It is important that billing department employees are clear and accurate when communicating with physician office personnel and patients. Never guess at the answer to a question; ask if you are unsure. Do not speculate or express personal opinions. When requesting diagnosis information from the physician office staff, be careful to not lead them to give a billable code. The code must come from the patient's medical record. Billing department employees must accurately state laboratory policies and procedures, or forward the call to a supervisor to avoid misstatements and misunderstandings. | View Page |
| Documentation All information related to diagnosis or other billing information received from a physician office must be documented. Documentation includes the name of the person collecting the information, the name of the person giving the information, and the date. This documentation must be linked to the original order. Billing department employees must ensure that complete records and documentation exist for all billing transactions.Not documented means not done. All communication, either written or verbal, with government, Carrier, or Fiscal Intermediary representatives must be documented. Employees should report instances where records are missing, incomplete, or improperly filed, to ensure that corrective action is taken. | View Page |
| Medical coverage policies (LMRPs) 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.
| View Page |
| Confidentiality All employees have a responsibility to maintain the confidentiality of medical information.
Medical information should never be discussed outside of the laboratory.
It should only be discussed with the ordering doctor or an authorized representative of the doctor.
Employees should verify the identity of the individual requesting such information
Employees who communicate with patients, physicians or their office staff, insurance company representatives or government employees about any laboratory activity should only give information they know to be true and accurate.
Employees should never give false information and should never guess the answer to any question.
In case of doubt, refer the person to a supervisor.
| View Page |
| Requisitions and ambiguous orders 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.
| View Page |
| Documentation and test release Documentation of compliance activities is the responsibility of all employees.
All forms must be completed and properly filed.
All procedures must be followed and properly documented.
If documentation of compliance activities cannot be established during an audit or investigation, the government will assume that the compliance program is not being followed.
Release of test results by phone, fax and other non-routine methods:
Employees should release test results only to the person who ordered the test.
Never release test results to another physician or entity unless authorized by the ordering physician in writing.
Never release the results of a test to a patient unless authorized in writing by the ordering physician.
| View Page |
| Physician notices and acknowledgements 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.
| View Page |
| Inducements 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."
| View Page |
| Phlebotomists and equipment in client offices 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.
| View Page |
| Marketing and record retention 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 record retention policy that ensures records are accessible in case of an audit or investigation.
Records should be retrievable.
Related documents should be linked.
| View Page |
| Utilization and other regulations 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. | View Page |
| ICD-9CM coding 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. | View Page |
| Local medical review policies (LMRPs) 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.
| View Page |
| Documentation All information related to diagnosis or other billing information received from a physician office must be documented.
Documentation includes the name of the person collecting the information, the name of the person giving the information, and the date.
This documentation must be linked to the original order.
Billing department employees must ensure that complete records and documentation exist for all billing transactions.Not documented means not done.All communication, (either written or verbal), with government, Carrier, or Fiscal Intermediary representatives must be documented.Employees should report instances where records are missing, incomplete, or improperly filed, to ensure that corrective action is taken. | View Page |
| Communication with physicians and patients It is important that billing department employees are clear and accurate when communicating with physician office personnel and patients.
Never guess at the answer to a question; ask if you are unsure.
Do not speculate or express personal opinions.
When requesting diagnosis information from the physician office staff be careful to not lead them to give a billable code:
The code must come from the patient's medical record.
There is an incentive program for patients to find and report fraud and abuse by health care providers, including laboratories, so:
Billing department employees must accurately state laboratory policies and procedures, or forward the call to a supervisor to avoid misstatements and misunderstandings.
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| Equipment and space 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. | View Page |
| Confidentiality and inducements 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.
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| Communicating with patients in person When communicating directly with patients concerning their laboratory tests or orders be careful not to discuss the following:
Why a test has been ordered by a physician.
What the test might indicate or what the test results mean.
Any opinions about their doctor.
Any information about internal laboratory issues.
Refer the patient to their doctor for information about the tests and the results.If the laboratory provides any printed information about tests that are designed for patients, give the patient that information. | View Page |
| Test orders Anytime an order is not clear, the physician office must be contacted.Do not use information supplied by a patient to clarify an order. Patients cannot add tests on their own. If a patient insists they want tests not specifically ordered by the doctor, the doctor should be contacted.When transferring a doctor's order from a non-standard form like a prescription pad to a laboratory requisition, it is important to ensure the accuracy of the order.Attach the original order document to the requisition sent to the laboratory.Follow all laboratory policies about panels and profiles, ambiguous orders and reflex tests. | View Page |
| Case Study 9 The setting is automated chemistry department, night shift, busy core laboratory for a hospital based outreach laboratory. A medical technologist who operates the automated chemistry analyzer on third shift encounters short samples a couple of times a night. When this happens, he runs as many of the ordered tests as he can and fills in the blank results with a comment indicating that a short sample occurred. As far as he knows there isn't a policy that addresses this problem directly.The test reports out with the results and the comments. The technologist does not have to change the physician order in any way and is providing the maximum results that can be reported for the specimen in a timely fashion. This is done as a matter of patient care and quality service. There has not ever been a complaint about this practice as far as he knows. Are there any additional steps this technologist should be taking?Correct Answer: The technologist should follow the procedures that the laboratory has in place for testing and billing samples for which there is no order or for ambiguous orders. If the policies do not seem to address his particular situation, he thinks there should be a separate policy to cover this situation or has a question about it, he should talk to his supervisor or to the laboratory compliance officerDiscussion: This choice addresses the problem in the most complete manner, in that the employee fulfills his responsibility to take action when he thinks there is a problem.
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| Case Study 2 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.
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| Case Study 3 It is 11:00 PM and the specimen processing department is finishing up the night's accessioning and test requesting. A specimen processor is working on a requisition that has an order for a Hepatic Profile but there are two tubes of blood with the order, one of which is a lavender top tube. This is the fourth requisition from this same doctor's office and all of them have had a lavender top tube and serum tube with an order for a chemistry test and a CBC. No CBC is marked on the requisition or written on the tube. The specimen processor figures the office just forgot to mark the test and knows that the results will be delayed and the sample might not be any good if he doesn't order the CBC now. He is also under pressure from the technical departments to finish processing on time so they can get their work done on time for result printing in the morning. What should the processor do?Correct Answer: Look up the laboratory's policy for handling such a situation and follow the policy.Discussion: The laboratory is not permitted to change a doctor's order in any way. By ordering the CBC the processor is ordering a test that the doctor did not specifically order and therefore makes the laboratory subject to a violation of the False Claims Act. By reviewing and following the laboratory policy the processor assures that the laboratory, the physician and the patient's best interests are met. | View Page |
| Case Study 4 Busy hospital laboratory in a 350 bed urban hospital that provides laboratory testing for the hospital and for the hospital's outreach testing laboratory. A medical technologist in the microbiology department receives a call from a friend who works in a laboratory in a physician office. The physician is not a regular client of the laboratory currently but uses another laboratory for most of their work. The microbiologist knows that the sales department would like to get this account. The friend explains to her that she is doing a quality control check on her in-office microbiology testing and her regular laboratory will do it but is going to charge her for it. She asks the microbiologist if she will do it for free since it is quality control, not Medicare and is not going to be billed to anyone.She tells the microbiologist that she would like to use the hospital lab for everything but her doctor insists on using the competitor. She indicates that the favor might help get the doctor to try the hospital laboratory for other tests. The microbiologist should:Correct Answer: Explain to her friend that if the hospital does the tests for no charge on the promise of other referrals, both the physician office and the hospital could be liable for violations of the antikickback statute.Discussion: The antikickback statute is implicated in this scenario because the free testing is solicited on the condition that other referrals may occur as a result of providing the favor. In fact, the solicitation itself is a violation of the law. The fact that Medicare patients are not specifically mentioned in the scenario is not sufficient to remove the risk. The technologist should also report the incident to the Compliance Officer and seek advise about what documentation, if any, should be kept concerning the incident. | View Page |
| At medical examination, a 50-year-old Caucasian male expressed concern regarding diabetes. There is a history of type 2 diabetes, hypertension, and cardiovascular disease in his family. He has gained a few pounds each year and his physician notes abdominal obesity. His physician orders laboratory tests to evalute his risk of cardiovascular disease.Vital Signs and Pertinent Laboratoy Results:Blood Pressure: 128/82 mm Hg Weight: 230 lbsHeight: 5' 11'' Calculated BMI: 32.1Waist Circumference: 45 inchesFasting Blood Glucose: 120 mg/dLTriglycerides: 170 mg/dLHDL-C: 42 mg/dLWhich one of the following statements regarding this patient is true if the physician uses the guidlines of NCEP: ATP III Diagnostic Criteria for metabolic syndrome evaluation? | View Page |
| A 45-year-old African American female has been diagnosed and treated for type 2 diabetes for the past five years. She maintains good control of her blood glucose with medication but does not exercise and has gained 12 pounds over the past year.At her next appointment, her physician orders hs-CRP along with blood assays to monitor her diabetes.Laboratory Result:hs-CRP 2.8 mg/L | View Page |
| A physician discusses weight with an overweight 60-year-old female at her yearly physical appointment. The female exercises regularly and eats healthy most of the time. The physician suggests she decrease carbohydrate intake and decrease portion size at meals.Review patient vital signs and laboratory assay results to decide if a diagnosis of metabolic syndrome is appropriate using the NCEP:ATP lll Diagnostic Criteria shown on the right.Height: 5' 7'Weight: 192 lbsBMI: 30.1Waist Circumference: 37 inchesBlood Pressure: 108/70Fasting Blood Glucose: 92 mg/dLTotal Cholesterol: 172 mg/dLLDL-C: 112 mg/dLHDL-C: 46 mg/dLTriglycerides: 70 mg/dLhs-CRP: <1.0 mg/LWhich of these statements regarding this patient is true? | View Page |
| References Armstrong C. Practice guidelines AHA and NHLBI review diagnosis and management of the metabolic syndrome. Am Fam Physician. 2006;74:891-1062.D'Amore PJ. Evolution of c-reactive protein as a cardiac risk factor. Lab Med. 2005;36:234-238.Devaraj, S, Swarbrick MM, Singh U et al. CRP and adiponectin and its oligomers in the metabolic syndrome evaluation of new laboratory-based biomarkers. Am J Clin Pathol. 2008;129:815-822.Eckel RH, Grundy SM, Zimmet PZ. The metabolic syndrome. Lancet. 2005;365:1415-1428.Expert Panel in Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (authors). Executive summary of the third report of the national cholesterol education program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III). JAMA.2001;285:2486-2497.Gade W, Gade J, Collins M et al. Failures of feedback: rush hour along the highway to obesity. Clin Lab Sci. 2010;23:39-50.Gade W, Gade J, Collins M et al. Beyond obesity: the diagnosis and pathophysiology of metabolic syndrome. Clin Lab Sci. 2010;23:51-61.Grundy SM. Does a diagnosis of metabolic syndrome have value in clinical practice? Am J Clin Nutr. 2006;83:1248-1251.Grundy SM, Brewer HB, Cleeman JI, et al. Definition of metabolic syndrome: report of the national heart, lung, and blood institute/american heart association conference on scientific issues related to definition. Circulation. 2004;109:433-438.Grundy SM, Cleeman JI, Daniels SR, et al. Diagnosis and management of the metabolic syndrome: An American Heart Association/National Heart, Lung, and Blood Institute scientific statement. Circulation. 2005;112:2735-2752.Grundy SM. Obesity, metabolic syndrome, and cardiovascular disease. J Clin Endocrinol Metab. 2004;89:2595-2600.Mathew B, Francis L, Kayalar A, et al. Obesity: effects on cardiovascular disease and its diagnosis. J Am Board Fam Med. 2008;21:562-568.Metabolic Syndrome. National Heart Lung and Blood Institute. Diseases and Conditions Index. Available at http://www.nhlbi.nih.gov/health/dci/Diseases/ms/ms_whatis.html. Accessed December 5, 2011.Mittal S. The Metabolic Syndrome in Clinical Practice. London, England. Springer-Verlag Springer Science; 2008.Molinaro RJ. Metabolic syndrome: an update on prevalence, criteria, and laboratory testing. MLO. 2007;39:24-27.Ronti T, Lupattelli G, Mannarino E. The endocrine function of adipose tissue: an update. Clin Endocrinol. 2006;64:355-365. | View Page |
| A 68-year-old female, who recently vacationed in Brazil, presented to her physician exhibiting overall weakness, fever, and enlarged lymph nodes. Blood was collected for culture and parasitic examination. The culture was negative. This suspicious form was recovered upon examining the Giemsa-stained preparation. This patient is most likely suffering from: | View Page |
| A 55 year old female, who recently returned from an extensive trip to China, presented to her physician complaining of diarrhea and abdominal cramps. The doctor ordered a complete blood count (CBC), chem 21 panel, and stool for culture and parasite examination (O & P). The CBC revealed pronounced eosinophilia. The chem 21 and stool culture were unremarkable. The O & P revealed suspicious forms like the one below that each measured approximately 140 µm by 80 µm. This patient is most likely infected with: | View Page |
| A 31 year old male missionary worker recently returned from Africa where he helped a small rural community update their sanitation practices. He presented to his physician weak and complained of recent weight loss, abdominal pain, and diarrhea that was often bloody. The doctor ordered a battery of tests including a complete blood count (CBC) and stool for parasite examination. The CBC revealed eosinophilia and anemia. This suspicious form was seen on the wet preparations. It measured 52 µm by 27 µm. What parasite is mostly likely present? | View Page |
| A 45 year old mother of two went to her physician because her children were recently diagnosed with ascariasis and she was concerned that she had also contracted the disease. Other than complaining of recent sporadic diarrhea, she was in overall good health. The doctor ordered a stool for ova & parasite examination. This suspicious form, measuring 55 µm was seen throughout the sample. This form is most likely: | View Page |
| A 27 year old female graduate student recently returned from South America, where she completed a nature study of the rain forest. She spent months "living off the land." The woman went to her physician seeking treatment for a sinus infection, which she thought was responsible for several recent bouts of diarrhea. Upon questioning the patient, the doctor decided to collect stool for culture and parasitic examination. The stool culture was reported as "no enteric pathogens isolated." This suspicious form was seen on both wet preparations and on permanent stain. It measures 17 µm. The identify of this form is most likely: | View Page |
| A 31 year old female with a known history of amebiasis, presented to her physician complaining of bloody diarrhea and fever. Previous patient history revealed that she lives in substandard conditions. Parasitic examination of the woman's stool revealed this suspicious form that measures 20 µm. The identification of this form is: | View Page |
| A 40 year old male recently completed a two-week hiking expedition in Russia. Upon his return to the United States, the man presented to his physician complaining of severe foul-smelling diarrhea and abdominal discomfort. The doctor immediately suspected a parasitic infection and ordered stool for examination. The sample was loaded with this suspicious form that averaged 13 µm in length. This patient is most likely suffering from: | View Page |
| A 27 year old West African immigrant went to the local clinic complaining of fever, chills, and joint pain. The physician immediately ordered blood for parasitic examination. The Giemsa-stained thin blood smear revealed the three suspicious forms below. This patient is most likely suffering from an infection with: | View Page |
| Basic Pharmacokinetics 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. | View Page |
| Steady State Most drugs are not given as a single dose but are part of a regimen. It is the physician's responsibility to prescribe a drug so that the concentration of that drug reaches a safe and effective level. The dosing-goal for the prescribing clinician, if multiple doses of a drug will be given, is for both the peak and the trough drug levels to be consistently within the therapeutic range. If a drug is given at intervals that are the same as its half-life, it will take about 5 half-lives to reach steady state. | View Page |
| Unexpected Concentrations 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. | View Page |
| A physician needs to prescribe a drug with a narrow therapeutic window. He is concerned about possible toxic effects. To assess the upper concentration of such a drug, which time for drawing the specimen do you think makes the most sense? | View Page |
| Clinical Utility 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. | View Page |
| The Bottom Line By knowing a patient's disposition to specific drugs, the physician should be able to start the patient on an appropriate regimen rather than perfecting treatment based on trial and error. Drugs whose metabolism may prove to be problematic can be avoided, and second-line therapies that are metabolized by different, unaffected enzymes can be chosen. Clinical chemists, pharmacologists, and physicians need to translate knowledge of CYP450 polymorphisms into clinically-validated treatment algorithms. Dosing recommendations for PM, EM, IM and UM patients are beginning to appear in the literature for various classes of drugs, and the FDA is encouraging the incorporation of pharmacogenomic testing in the development process for new drugs. | View Page |
| Warfarin Metabolism 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. | View Page |
| Case 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. | View Page |
| Discussion The phlebotomist should always carefully observe the patient for clues about his mental and physical condition. In this case, the patient verbally expressed her fear of needles. In other cases, such fear may be expressed on the patient's face or through other clues. It may help to engage apprehensive patients in conversation during the venipuncture to keep their mind off the procedure.As soon as the patient stated that she felt faint, the procedure should have been terminated. If a sitting patient faints, placing her head between her knees will help to revive her. Make sure the patient does not injure herself. Ammonium (smelling) salts, if in use at your institution, should be used cautiously, since they can be irritating. Get help from the nursing staff or a physician. Stay with the patient at least 15 minutes. The patient should not leave the area for at least 30 minutes. Make sure other appropriate institutional procedures are followed after fainting.Relevant topics:Fainting, Fainting continued | View Page |
| Discussion 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 | View Page |
| Record elapsed time Record the time elapsed when bleeding stops.If bleeding persists more than 15 minutes:Stop the test.Apply pressure to the wound.Notify a physician.Record the bleeding time as greater than 15 minutes.
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| Patients Refusing Blood Work 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. | View Page |
| What is a phlebotomist's role in health care facility? [continued] Phlebotomists work in a variety of settings including:
Hospitals
Physician Offices
Nursing Homes
Home Health Care
Clinics, and
Military facilities.
A well trained phlebotomist will therefore have a variety of job opportunities available.Other medical professionals, including nurses, respiratory therapists, and medical assistants may also be trained to collect blood specimens.
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| Laboratory work-flow cycle 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.
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| Work-flow cycle: test performance to treatment Laboratory performs analytical tests.
Lab results are returned to physician.
Physician treats patient based on results of lab tests. | View Page |
| Professionalism: maintaining confidentiality 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.
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| Patient observation Observe the patient carefully during the procedure and be on the lookout for reactions such as nausea and vomiting.
If these or other symptoms persist, contact the patient's physician. You may need to terminate the test.
Of course, always follow your institution's specific procedure for performing glucose tolerance tests. | View Page |
| Introduction 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. | View Page |
| References 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 | View Page |
| Case Study The image on the right is representative of the peripheral blood smear from a five-month-old immigrant from Asia. Her mother was concerned that the child was not eating well. Her spleen was palpable.These blood count results were reported:ParameterPatient ResultReference IntervalRBC5.5 x 1012/L3.1 - 4.5 x 1012/LHgb9.6 g/dL9.5 - 13.5 g/dLHCT30.4%29- 41%MCV55.4 fl74 - 108 flMCH17.5 pg25 - 35 pgMCHC31.6 g/dL30 - 36 g/dLRDW34.9%11 - 15%Reticulocyte10.9%0.5 - 4.0%Knowing that the family is from a region of Thailand where HbE carriers are prevalent, the physician ordered a hemoglobin electrophoresis. The hemoglobin electrophoresis detected HbE. Based on the blood count results and this representative microscopic field, which of the following peripheral blood findings should be reported? | View Page |
| Introduction to Red Blood Cell Morphology Reporting 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. | View Page |
| Case Presentation 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. | View Page |
| Use in Pregnancy As applied to pregnancy, RhIg's purpose is to prevent immunization to the D antigen in the perinatal period and thus prevent HDFN due to anti-D. If the mother has already produced anti-D, RhIg is of no use.Accordingly, RhIg is routinely administered to Rh negative women* not previously sensitized to the D antigen under the following circumstances:1, Antenatal. Antepartum prophylaxis of 300 µg (1500 IU) at about 28 weeks gestation in the USA and Canada, which could be weeks later, depending on how physician appointments are scheduled. To illustrate variation in antenatal international practice, in the UK smaller doses of RhIg (e.g., 500 IU) may be given at 28 weeks and 34 weeks, although many UK facilities issue a 1500 IU dose at 28–30 weeks. With antenatal administration, the Rh of the fetus is usually unknown. Some transfusion services recommend a further antenatal dose if the infant is undelivered after 40 weeks.2. Postnatal. Prophylaxis of 300 µg (1500 IU) at delivery of an Rh positive or weak D infant, preferably within 72 hours of delivery but can be given up to 28 days later if administration is delayed. If RhIg administration is delayed beyond 72 hours, laboratory policies differ as to when it would no longer be administered.* Policies related to women who are weak D (formerly Du) are discussed later.Note: Because RhIg contains IgG anti-D, when given antenatally, it can cross the placenta and sensitize fetal D-positive red cells. Occasionally the fetus may be born with a weakly positive DAT, but significant hemolysis does not occur. | View Page |
| RhIg 'Failures' 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. | View Page |
| Case Presentation 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. | View Page |
| Literature and online resources LiteratureDutton RP, Shih D, Edelman BB, Hess J, Scalea TM. [abstract]. Available at: Safety of uncrossmatched type-O red cells for resuscitation from hemorrhagic shock.J Trauma. 2005 Dec;59(6):1445-9. Accessed November 5, 2012.Johnson ST, Rudmann SV,Wilson, SM. Serologic problem solving strategies:a systematic approach. Bethesda, MD: AABB, 1996.Online resourcesThe following are online examples of good practice. The information should not be used as a substitute for technical and clinical judgment. Medical and technical information becomes obsolete quickly and current sources relevant to the user's location should always be consulted.Transfusion reactions: Transfusion complications (Canadian Blood Services)Education website for CBS's hospital customersREACT (Sunnybrook HSC, Toronto, ON, Canada) Pocket reference card for nurseson signs and symptoms of transfusion reactionsQuick cals (online calculator of p values for Fisher's exact test) Use a one-tailed test (since we would expect an antibody to react with red cells that are positive for the corresponding antigen) | View Page |
| The antibody screen is positive but the transfusion of the O Rh-negative RBCs is already in progress. What are the transfusion service (TS) laboratory's priorities in this case?Place the following procedures that will be followed by the TS in the appropriate order of priority. | View Page |
| Other post-transfusion tests The patient's post-transfusion plasma was also retested with the 6 RBC that tested positive initially. Like the antibody panel done on the post-transfusion plasma, they are now all negative by gel IAT.Unfortunately, the panel results with the patient's post-transfusion eluate do not give clear results (only cells #1 and #9 react) and the antibody remains unidentifiable. Suppose that the physician had decided to continue transfusing the patient at this stage. Take a moment to think about what you would advise regarding the compatibility of such transfusions, all of which appear to be compatible in the crossmatch. When you have considered the options, continue to the next page. | View Page |
| Consulting the patient's physician 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. | View Page |
| Follow-up with clinical staff The patient's physician was notified that compatible blood was unavailable and that the patient's antibody was still being investigated.When asked whether or not the patient was experiencing a transfusion reaction due to the transfusion of the two unmatched and incompatible O Rh negative RBC, the nurse in the OR stated that the patient was undergoing surgery and completely sedated. A transfusion reaction was not apparent but they would investigate and closely monitor.Hemolytic Transfusion Reactions (HTR)Before proceeding to the next page, make a short list of signs and symptoms associated with immediate hemolytic transfusions reaction and another list associated with delayed hemolytic transfusion reactions. | View Page |
| Guidelines for Diagnostic Testing and Treatment 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. | View Page |
| Treatment Options for H1N1 Infection Most patients who have suspected or confirmed cases of H1N1 infection have a mild, uncomplicated, self-limited illness that may not require antiviral treatment. If infected individuals have a normal immune system, they should be able to recover from the infection with symptomatic treatment only and without antiviral therapy. However, it is the decision of the patient's physician whether to treat or not to treat. The CDC provides this decision tree as a guideline if the illness is mild and uncomplicated:The CDC suggests that patients with suspected or confirmed influenza should be treated if: They are hospitalized as a result of the illness They are at risk for severe disease including these patients: Patients that have certain medical conditions, such as asthma, diabetes, heart disease, or patients with weakened immune systems that may exacerbate the infection. Children younger than 2 years old Adults 65 years or older Pregnant women or women up to 2 weeks post-partum They have a progressive or complicated illness characterized by signs of: lower respiratory tract disease such as hypoxia or abnormal chest x-ray CNS complications such as encephalitis Complications of low blood pressure including shock or organ failure Myocarditis Invasive secondary bacterial infection The treatment options indicated for the 2009 H1N1 infection include oseltamivir (brand name Tamiflu®), an oral tablet, and zanamivir (brand name Relenza®), an inhaled antiviral agent.Reference: Centers for Disease Control and Prevention. Updated interim recommendations for the use of antiviral medications in the treatment and prevention of influenza for the 2009-2010 season. December 7, 2009. Available at: http://www.cdc.gov/h1n1flu/recommendations.htm. Accessed January 18, 2010. | View Page |
| H1N1 Vaccine 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. | View Page |
| Other CDC Actions for the Influenza A 2009 H1N1 Virus The CDC not only monitors the influenza A 2009 H1N1 virus, but also provides guidance to physicians, public health/healthcare employees, and the general public. The CDC also ensures that there are sufficient quantities of medicines and medical supplies in the event of a public health emergency. The branch in charge of stockpiling and dispersing these supplies is called the Strategic National Stockpile or SNS, which is a division of the CDC. During the outbreak of the H1N1 virus, the SNS dispersed antiviral drugs and respiratory protection devices and other personal protective equipment (PPE) across the United States as well as U.S. territories to assist in the response to the Influenza A 2009 H1N1 virus. | View Page |
| Preliminary Laboratory Investigation 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. | View Page |
| What is the first step a transfusionist should take when a transfusion reaction is suspected? | View Page |
| Procedure for a Suspected Adverse Reaction 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. | View Page |
| Transfusion Reactions: Introduction ".....In the past, a person with blood type O negative blood was considered to be a universal donor. It meant his or her blood could be given to anyone, regardless of blood type, without causing a transfusion reaction. This is no longer a relevant concept because of a better understanding of the complex issues of immune reactions related to incompatible donor blood cells." Reference: Mayo Clinic Health Oasis - Ask a Physician 08/09/2000. As quoted in: Blood types and compatibility. Bloodbook.com; 2005. Available at: http://www.bloodbook.com/compat.html. Accessed April 26, 2011.Transfusion of blood components is generally a safe and effective way to correct hematologic deficits. However, a transfusion reaction may occur and health care providers must be aware of the risks involved with blood transfusions and evaluate the risks against the potential therapeutic benefits. A transfusion reaction can be defined as any adverse event occurring during or after the transfusion of blood components. Adverse events can range from fever and hives to renal failure, shock, and death. Some adverse events can be prevented, but others cannot. | View Page |
| Diagnosis 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. | View Page |
| Smudge Cells 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. | View Page |
| Additional Comments The following pages in this presentation includes a series of white blood cell and platelet abnormalities (nonneoplastic) that may be identified in a peripheral blood smear. Many cases will simulate the practice of a peripheral smear review by a hematology technologist. He or she must assess what responses in patient care may be triggered by the clinician attempting to interpret the reported findings on a peripheral smear.Observations of white blood cell abnormalities in the peripheral blood smear should be reported in order to direct the physician to an immediate specific diagnosis, such as: Atypical lymphocytes, suggesting infectious mononucleosis rather than leukemia Toxic granules in neutrophils, as found in acute infections, or atypical granules suggesting a genetic disorder An unusual mix of cells, such as too many or too few neutrophils, monocytes, or other myeloid cells The presence of giant platelets, myelocytes, or other cells, suggesting a myelodysplastic syndromeIn summary, laboratory data should be presented to clinicians in a user-friendly fashion to promote effective decision making. | View Page |
| Chediak-Higashi Anomaly 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. | View Page |
| Approximately 10% of the circulating white cells were similar to the one seen in this image. The patient was 42 years old and visited his physician because of recent bruising. Note the absence of platelets on the smear. Possible associated conditions include: | View Page |
| Case History One 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. | View Page |