MID M AM MERICA A CLLINICA AL LAB BORATTORIEES, LLC C Dirrectory of o Service es Refference Guide G Pub blished: December 21,, 2011 Mid America Clinical Labora atories, LLC r reserv ved All rights Mid America Clinical Labora atories ectory of Serrvices Dire 2560 North Shadeland Aven nue N 46219-016 63 Indianapolis, IN 1 Table of Contents About Mid America Clinical Laboratories, LLC ............................................................................................... 3 Mid America Clinical Laboratories’ Vision for the Future................................................................................................................................................3 Description of Laboratories ......................................................................................................................................................................................................3 Quality Assurance and Laboratory Accreditation .............................................................................................................................................................3 Client Response Center (CRC) ..................................................................................................................................................................................................4 Courier Services/Specimen Pick-up .......................................................................................................................................................................................4 Hospital Based Lab (HBL) Test Availability ...........................................................................................................................................................................5 Patient Service Center Network ..............................................................................................................................................................................................5 Professional Consultations ........................................................................................................................................................................................................6 Reference Ranges .........................................................................................................................................................................................................................6 Result Reporting ...........................................................................................................................................................................................................................6 Test Additions – After Submission of Specimen ................................................................................................................................................................6 Web Page ........................................................................................................................................................................................................................................6 MACL’s Directory of Services (DOS)........................................................................................................................................................................................6 Unlisted Tests/Tests Not Found In This Directory of Services .......................................................................................................................................6 General Specimen Collection Information ..................................................................................................... 8 Introduction ...................................................................................................................................................................................................................................8 Proper Labeling.............................................................................................................................................................................................................................8 Health and Safety Precautions .................................................................................................................................................................................................9 Unacceptable Specimens ..........................................................................................................................................................................................................9 Blood Collection ........................................................................................................................................................................................................................ 10 Urine Collection ......................................................................................................................................................................................................................... 12 Coagulation Specimen Collection and Handling ........................................................................................................................................................... 13 Microbiology Specimen Collection and Handling ....................................................................................... 14 Cytopathology Specimen Collection and Handling ..................................................................................... 22 Reflex Testing .................................................................................................................................................. 28 Client Information .......................................................................................................................................... 30 Account Management Team ................................................................................................................................................................................................. 30 Billing ............................................................................................................................................................................................................................................. 30 Ordering Supplies ..................................................................................................................................................................................................................... 31 Instructions for Packaging Specimens and Test Requisitions .................................................................................................................................... 32 Allergy Evaluations ......................................................................................................................................... 35 General Test Listings Interpretive and Additional Information (from Quest Diagnostics, Inc.) 2 About Mid America Clinical Laboratories, LLC Mid America Clinical Laboratories is an independent clinical laboratory jointly owned by the Community Hospital Network, St. Vincent Hospitals and Health Services, Quest Diagnostics, Inc., and CoLab, LLC. Mid America Clinical Laboratories embraces, from its founders, the concept of quality, service and excellence by working together. Mid America Clinical Laboratories is customer-oriented, provides open and honest communication to engender trust and integrity with all of its customers and works with its associates as team members. In addition, Mid America Clinical Laboratories recognizes that it is an extension of its founders and will recognize their missions’ emphasis on efficiency, respect for the individual, simplicity and quality improvement. The primary objective of the partners in Mid America Clinical Laboratories (MACL) is to provide Indiana-based laboratory services to physician practices throughout central and northern Indiana and to improve the efficiency of the individual hospital laboratories. It is the mission of Mid America Clinical Laboratories to provide a full range of clinical laboratory services to patients and other customers with an emphasis on high quality, efficiency and responsiveness. Mid America Clinical Laboratories’ Vision for the Future At Mid America Clinical Laboratories, we are striving to Be First in Customer Satisfaction Through Service, Information and Innovation. Each of our associates is committed to our Values: • Commitment to Service • Creativity • Integrity • Respect • Quality Description of Laboratories The Hospital Based Laboratories (HBLs) provide transfusion services, chemistry, hematology, coagulation, urinalysis and rapid microbiological tests when results are needed for the immediate treatment of the patient. The Regional Laboratory performs routine testing when results are not required immediately. Most microbiology and esoteric testing is performed in the Regional Laboratory because the technology precludes rapid turnaround (e.g. bacterial cultures). Three laboratory/patient service centers provide a limited STAT testing menu as well as specimen collection services. Quality Assurance and Laboratory Accreditation Board certified anatomic and clinical pathologists direct laboratory activities, providing supportive services in both the medical and technical areas. Well trained and competent certified medical technologists, cytotechnologists and technicians as well as a comprehensive and continuously monitored quality control program enable Mid America Clinical Laboratories to provide precision and accuracy in its test results. Day to day quality and accuracy are assured by internal and external proficiency testing programs. Mid America Clinical Laboratories is accredited or approved to provide laboratory services by the following organizations: American Association of Blood Banks (AABB) Centers for Medicare Services Clinical Laboratory Improvement Amendment (CLIA) College of American Pathologists (CAP) Indiana State Department of Health Medicaid 3 MID AMERICA CLINICAL LABORATORIES SERVICES Client Response Center (CRC) At Mid America Clinical Laboratories, we recognize that lab quality is defined by clinical quality and service quality. We will continually strive to understand, respond to and meet the needs of our clients through functioning as a client advocate, recognizing and responding to service opportunities and facilitating resolution. We maintain a telephone call center staffed with courteous and knowledgeable associates, available to answer questions and offer assistance in obtaining laboratory testing services. The MACL Client Response Center assists with questions about our test menu or test results. CRC also helps with referrals to the appropriate Mid America employee to assist with problem resolution and professional consultation. The Client Response Center is staffed seven days a week and calls are answered 24 hours each day. All customer inquires relative to specimen requirements, test results, test information, hard copy reports, etc., should be directed to the Client Response Center at (317)803-1010 or (877)803-1010. Courier Services/Specimen Pick-up Courier service for specimen pick-up and supplies delivery at physician offices, clinics, hospitals and nursing homes is available daily throughout our service area. Our couriers work on a schedule designed to meet our customers’ needs. Calls for pick-ups and ordering supplies should be directed to (317)803-1020. 4 Hospital Based Lab (HBL) Test Availability A limited menu of laboratory tests are available in all of the hospital-based facilities. STAT orders for these tests are usually resulted within one hour or less of specimen receipt. The list is comprehensive, and not all tests are available at every site. Acetaminophen Acetone Albumin Alcohol Alkaline Phosphatase ALT Aminophylline Ammonia Amylase AST Basic Metabolic Panel Bilirubin, Direct Bilirubin, Neonatal Bilirubin, Total Blood Gas BNP Body Fluid, pH BUN Calcium Carbon Monoxide CBC w/o Diff CBC with Diff Cell Count, CSF Cell Count, Joint Fluid Chloride, Blood CKMB CO2 Comprehensive Metabolic Panel CPK Creatinine D-Dimer Digoxin Dilantin Drug Screen, Urine Electrolytes, Blood Electrolytes, Urine Factor VIII Activity Factor IX Activity Fetal Fibronectin Fetal Hemoglobin (APT) Test Fibrinogen Gentamicin Glucose, Blood Glucose, CSF Gram Stain Group A Strep Screen, Rapid HCG, Qualitative, Serum HCG, Qualitative, Urine HCG, Quantitative, Serum Hepatic Panel India Ink Influenza A & B by EIA Ionized Calcium Lactic Acid, Blood Lamellar Body Count LDH Lipase Magnesium O2 Saturation/Oxyhemoglobin Occult Blood, Fecal Occult Blood, Gastric Phenobarbital Phosphorous Platelet Count Platelet Function Test Potassium, Blood Potassium, Urine Protime, PT PTT, Partial Thromboplastin Quantitative Dimer Renal Panel RSV by EIA Salicylate Sed Rate Sodium, Blood Sodium, Urine Specific Gravity, Urine Tegretol Total Protein, Blood Total Protein, CSF Trichomonas Prep Troponin I Uric Acid, Blood Urinalysis Valproic Acid Vancomycin Methemoglobin Mono Screen WBC, Stool Patient Service Center Network Mid America Clinical Laboratories has a comprehensive network of Patient Service Centers (PSCs). Our PSCs provide specimen collection services, including the following: • • • • Routine phlebotomy (venipuncture) Urine collections Capillary sticks Throat swabs In addition to specimen collection, we have three laboratory service centers and our hospital-affiliated labs that also provide a limited STAT test menu to support medically urgent situations. Locations for PSCs are available by calling CRC at 317-803-1010 or on the internet at www.maclonline.com. 5 Patients must bring a Mid America Clinical Laboratories test requisition for service at our locations. The test requisition must be completed with specific test order codes, all medically appropriate diagnosis codes as provided by the physician, patient demographics and billing or insurance information. Professional Consultations Members of our staff are available for questions or medical and technical consultation. Our Client Response Center Representatives can provide assistance in contacting the appropriate Mid America staff member for professional consultation. Reference Ranges Reference ranges (normal ranges) for interpretation of results will be included on each patient test report. Because of continuing improvements in methodology and expanding knowledge in clinical interpretation, reference ranges do not remain static in a progressive laboratory. Each report will carry current reference ranges for the specific test. Result Reporting In accordance with regulations governing clinical laboratories and in order to maintain the confidentiality of records, it is the policy of Mid America Clinical Laboratories to release test related information to only the person who ordered the test or that person’s authorized representative. Written reports are delivered electronically or by mail. Alert (critical) results are flagged in the laboratory computer system when results exceed the verification range. All alert and STAT values will be telephoned as soon as they are available, followed by written reports. Turnaround times for STAT tests performed on site in the Hospital Based Labs will be one hour or less from time of receipt in the lab. Turnaround times for routine tests performed on site at the Regional Laboratory will usually be 12 hours. Most microbiology and esoteric test results are available within 48 to 72 hours of specimen receipt. Test Additions – After Submission of Specimen The Client Response Center (CRC) can arrange for additional testing if sufficient specimen type and volume remains after the initial tests have been completed. To request a test addition, contact CRC at 317-803-1010. We are required by federal regulations to obtain written authorization for every test we perform. A hard copy request for written confirmation will follow all verbal test requests. An employee authorized by the requesting client or physician must sign this written confirmation. Web Page A wide variety of information about Mid America Clinical Laboratories is available at www.maclonline.com. Information on lab test requirements, locations of our patient service centers, copies of our monthly newsletters, and employment opportunities can be viewed. MACL’s Directory of Services (DOS) Mid America Clinical Laboratories’ Directory of Services (DOS) contains all the information needed to order and procure testing services. The DOS is made available to all customers and prospective customers in a variety of convenient, user-friendly formats, including our web page, on CD and in printed versions. Unlisted Tests/Tests Not Found In This Directory of Services We are continually developing new procedures. As a result, some tests may not be listed in this edition of the Mid America Clinical Laboratories DOS. Additionally, certain procedures are no longer offered because they have become obsolete. Contact the Client Response Center for information on tests not found in this DOS. 6 Mid America Clinical Laboratories will accept testing that is referred to other facilities as a convenience to our clients if that laboratory is a testing partner of ours. A handling fee will be charged except as prohibited by law. 7 General Specimen Collection Information Introduction The quality of any laboratory test result is dependent on many variables. First, the patient must be properly prepared so that the best possible specimen can be collected. Next, the actual collection of the specimen must be completed. Then, the specimen should be properly processed, packaged and transported to the laboratory in a timely manner and under environmental conditions that will not compromise the integrity of the specimen. After all of these activities take place, a quality analysis can be performed. Specific specimen requirements for each test are listed in the General Test Listing section of this directory. Specimen requirements include information such as specimen volume, collection and transport containers as well as transport temperature. If additional information is needed for the interpretation of the test results or there are specific instructions for patient preparation, they are listed along with specimen requirements. It is critical that an adequate specimen volume is submitted for analysis. The volume requested in this directory will be enough for initial analysis, as well as any confirmatory tests that must be performed. If an inadequate specimen is submitted, we may not be able to perform the initial test or required confirmatory procedures. If repeat or confirmatory tests cannot be performed, the report will indicate that specimen quantity submitted was “QNS” (Quantity Not Sufficient) for additional testing. When serum or plasma is to be submitted for analysis, it is generally a good practice to collect a volume of blood that is 2 to 2.5 times the volume of serum or plasma needed for the test. As an example, if 4 mL of serum or plasma is needed for a test, collect 8 to 10 mL of blood. When an inappropriate specimen or unclear test requisition has been submitted, the ordering physician will receive notification with instructions for resolving the problem. To prevent future delays, a report will be issued with information regarding proper specimen submission. Proper Labeling 1. Test Orders All laboratory specimens must be accompanied by a valid order. The order may be a manual or computer requisition and must indicate the patient first and last name. It is recommended that the patient’s name on the primary container exactly match that on the requisition. In addition, test orders, date and time of collection, patient medical record number (for hospital registered patients), order number and ordering physician name must be included. MACL clients are assigned a unique customer number which is preprinted on the test requisitions. In general, specimens will not be accepted in the laboratory without an order, an ordering physician, and without a patient name. 2. Hospital Patients The identification label must be completed and affixed to the primary container after the specimen has been collected and before the specimen is taken from the patient’s room. The following information must be included on the label: a. b. c. d. e. f. g. h. I. Patient’s name (no nicknames) Hospital registration number Medical Record number Date and time collected Patient’s room number IS order number Source of specimen, (other than blood). Fi O2 for blood gas specimens Initials of the person obtaining the specimen 8 3. Outside Facilities/Clients The specimen is labeled by the individual obtaining the specimen. The following must be included on the label: a. b. c. d. Patient’s name, written exactly as it appears on the test requisition Account number Date and time collected Source of specimen (other than blood). When submitting a specimen in a transfer tube, the specimen type must be indicated on the transfer tube label (e.g., serum, plasma, urine). Note: When ordering tests in a series (e.g., growth-hormone stimulation, glucose tolerance, multiple-site renin specimens); 1) Use one test requisition. 2) Label each specimen with the patient’s unique identifier, date and time of collection (if applicable), site (if applicable) or other pertinent condition under which each specimen was collected. 3) Write the number of specimens on the test requisition. 4) Submit all specimens within a series together in one specimen bag. Health and Safety Precautions All specimens should be handled as if they are infectious. The greatest dangers to health care workers exposed to blood and body fluids are the Human Immunodeficiency Virus (HIV) and the hepatitis viruses. The following safety guidelines must be followed when preparing specimens for transport to Mid America Clinical Laboratories. a. Specimen container must be properly sealed. A leaking container not only compromises specimen integrity but poses a health hazard for those handling the specimen. A leaking specimen can also contaminate the requisition which is a safety hazard throughout the process. b. Specimens collected in syringes will not be accepted with the needle attached. The needle must be removed and a syringe port attached. c. All specimens must be transported in a plastic ziplock bag as secondary containment. This protects anyone handling the specimen in case of leakage or breakage. d. All specimens from outside facilities are transported in coolers with a fixed Biohazard label. This meets the requirements of CFR 1910.1030. (G), “Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment, or disposal are exempted from the (individual specimen) labeling requirement.” e. Clients have the responsibility to secure the specimen for transportation in a locked box. It is the customer’s responsibility to report to local authorities any loss of or tampering with specimens occurring before pickup by Mid America Clinical Laboratories. Unacceptable Specimens Specific instructions for storage and shipment of specimens for individual tests are listed under specimen requirements in the alphabetical listing of laboratory tests. Occasionally, blood specimens are contaminated with substances that interfere with accurate sample analysis: 1. Hemolysis - Hemolysis occurs when the membrane surrounding red blood cells is disrupted and hemoglobin and other intracellular components escape into the serum or plasma. (This may occur with a difficult draw.) 9 Hemolyzed serum or plasma varies in color from faint pink to bright red, rather than the normal straw color. Even a slight hemolysis will alter certain test results. Grossly or moderately hemolyzed specimens may be rejected. 2. Hyperbilirubinemia - Icteric serum or plasma varies in color from dark to bright yellow, rather than the normal straw color. Icterus may affect certain test results. Upon receipt of such specimens, we may request a new sample to assure results of diagnostic value. 3. Radioisotope interference - Diagnostic procedures or therapy involving radioactive compounds may invalidate radioisotope assays. Obtain specimens for anticipated radioisotope assays before administering isotopes to the patient. 4. Turbidity - Turbid, cloudy or milky serum (lipemic serum) may be produced by the presence of fatty substances (lipids) in the blood. Bacterial contamination may also cause cloudy serum. Moderately or grossly lipemic specimens may alter certain test results. A recent meal can produce transient lipemia. For the majority of tests performed on serum, plasma or whole blood, a fasting specimen is preferred. Fasting is defined as no consumption of food or beverage, other than water, for at least 8-12 hours before testing. The fasting specimen provides information that reflects the physiological baseline of the patient. This information can easily be compared to information from tests obtained at other times and provides a means for reliably monitoring a patient’s condition for the duration of their care. Blood Collection 1. Blood, Plasma Plasma contains fibrinogen and other clotting factors when separated from the red cells. Evacuated tubes used to collect plasma specimens contain an anticoagulant and frequently a preservative. The additive in the tube is specified and correlates to the color of the tube stopper. Consult the individual test specimen requirement or Mid America Clinical Laboratories’ tube collection chart to determine the correct additive/tube to use. Perform venipuncture. Invert tube gently at least 8 times, 4 times for light blue tubes. If the plasma is removed from the original vacutainer vial, the transfer tube and requisition must be labeled to indicate that the specimen is plasma. 2. Blood, Serum We recommend the use of serum separator collection tubes for most analyses. However, please check individual specimen requirements for restrictions. Perform venipuncture. Invert the tube gently at least five times. Centrifugation Instructions: 3. a. Do not remove the stopper at any time. Allow the blood to clot in an upright position at least 30 minutes (but not more than 60 minutes) before spinning. Do not centrifuge immediately after drawing blood. b. Centrifuge at greater than 3000 RPM for 10 minutes. c. Normally the specimen is transported to the laboratory in the original vacutainer. Only transfer serum to a plastic vial when immediate freezing is necessary. Label the transferred specimen as serum. Do not freeze the glass tubes. Blood, Whole 10 Collect whole blood according to the instructions provided for the individual test. Thoroughly mix the blood with the additives by gently inverting the tube at least ten times. Maintain the specimen at room temperature before transporting to our laboratory unless instructed otherwise by the specimen requirements. Never freeze whole blood unless specifically instructed by the specimen requirements. 4. Common Blood Collection Tubes and Additives HEMOGARD CLOSURE Plain Red RUBBER STOPPER Plain Red ADDITIVE Light Blue Light Blue Sodium Citrate. 0.105 M, (3.2%) Removes calcium to prevent clotting. Green Green Inhibits thrombin formation to prevent clotting. Lavender Lavender Sodium heparin, lithium heparin EDTA Pink N/A EDTA Removes calcium to prevent clotting. Gold Black/Red Gel separator/ clot activator Gray Gray Royal Blue Royal Blue Sodium fluoride, Potassium oxalate None Clot activators shorten the time for clot formation. The gel forms a barrier between cells and serum. Inhibits glycolysis. Removes calcium to prevent clotting. None EDTA Tan Tan EDTA White N/A EDTA/Gel ADDITIVE FUNCTION Contains no anticoagulants and no additives. Removes calcium to prevent clotting. Contains no anticoagulant. CONSIDERATIONS No additive. Clot formation takes 30 minutes. Tube should be full and mixed well. Blood to anticoagulant ratio very important (9:1). Be careful of the type of heparin that is being used for what type of testing. Should be well mixed; invert 6-8 times. Should be well mixed; invert 6-8 times. Tubes should be inverted 5 times to expose the blood to the activator. Centrifuged after clot formation is complete. Should not be used for other chemistries. Chemically cleaned and the rubber stoppers contain low levels of metals. Removes calcium to prevent clotting Inhibits thrombin formation to prevent clotting. Removes calcium to prevent clotting. The gel forms a barrier between the plasma and cells. 11 Chemically cleaned and the rubber stoppers contain low levels of metals. N/A LABORATORY USE Serum chemistries, serology, body fluids, therapeutic drug monitoring. Coagulation studies, PT, APTT, factor assay. Plasma chemistries. Whole blood hematology cell counting, CBC. Blood Bank tests ONLY. Most chemistry testing and some drug levels. Not suitable for Blood Bank testing. Glucose testing, glucose tolerances, alcohol levels Toxicology, trace metals. Lead Some Hepatitis and HIV PCR tests. Urine Collection 1. Urine, Chemistry The normal composition of urine varies considerably during a 24 hour period. Most reference values are based on analysis of the first urine voided in the morning. This specimen is preferred because it has a more uniform volume and concentration, and its lower pH helps preserve the formed elements. Urine for pregnancy testing should be a first morning voiding, or a random specimen with a specific gravity of at least 1.010. Note the time of collection of the specimen on the test requisition form and on the label of the container. 2. Urine, Hematology (Urinalysis) To reduce contamination, the specimen submitted for urinalysis should be a clean catch “midstream” sample. Submit a first morning specimen whenever possible. Instructions for collecting a clean catch midstream specimen are located on page 18-19. 3. Urine, Cultures See Microbiology Specimen Collection section for specific instructions (pages 18-19). 4. Urine, 24-Hour Collection Because proper collection of 24 hour urine specimens is essential for accurate test results, patients should be carefully instructed in the correct procedure. Printed instructions for the patient are available from the laboratory. 5. a. Unless the physician indicates otherwise, instruct the patient to maintain the usual amount of liquid intake but to consume no alcoholic beverages. b. During the collection period, keep the 24 hour urine container in a refrigerator or cool place to prevent growth of microorganisms and possible decomposition of urine constituents. c. Have the patient empty his/her bladder in the morning into the toilet (not to be included in the 24 hour collection). Write the date and time of voiding on the container label. d. Collect the patient’s next voiding and add it as soon as possible to the 24 container. e. Add all subsequent voidings to the container as in Step d. The last sample collected should be the first specimen voided the following morning at the same time as the previous morning’s first voiding. f. The start and stop times, along with the total volume, must be recorded on the specimen container. hour Urine Drug Screens Non-forensic screening for drugs of abuse occurs when a urine specimen is submitted without a forensic chain of custody form. This testing is performed 24 hours a day in the Hospital Based Laboratories and is resulted within one hour of specimen receipt. The method of testing is a qualitative detection of the major metabolites of the drugs of abuse. The results are used for emergency medical/clinical diagnostic purposes and can not be used to take legal or punitive action. For non-emergency medical/clinical diagnostic purposes, a more comprehensive non-forensic screen for drugs of abuse is available. 12 Forensic testing requires a special collection kit containing a chain of custody form, security seals and specimen collection container. Collection of these specimens are done by appointment in several of the Mid America Clinical Laboratories Patient Service Centers. Call 317-803-1010 for locations. The patient must bring a picture ID to confirm patient identification. Patients without proper identification will not be able to be tested. Forensic testing must have a physician’s order, agreement with an employer, or a court order before the laboratory can collect the specimen. The specimens are sent out to a reference laboratory for testing. Note: Forensic screening for drugs of abuse is not performed on an inpatient basis. Coagulation Specimen Collection and Handling For coagulation testing to be valid, critical attention must be paid to the collection and processing of these blood samples. These instructions must be followed. Deviation from them will significantly alter the results. 1. If a number of different tubes are to be collected from a patient, the order of the draw of the tubes is as follows: a. Light blue top tubes* b. Serum tubes (gold, red/black, red) c. Green top tubes d. Lavender or pink top tubes e. Gray top tube *In the event that only light blue top tubes are to be drawn, and a winged blood collection set is being used, a red top tube must first be collected before drawing the blue top tube. This will fill the tubing’s dead space to ensure maintenance of the proper blood-to-additive ratio. 2. Venipuncture must be clean with no trauma. Hemolyzed samples are not acceptable. 3. Mix sample gently by inverting the tube(s) 4 times immediately after filling. 4. Deliver specimens to the laboratory within 30 minutes of collection. 5. Tube must be properly filled. The correct ratio of blood to citrate is critical (9:1). 6. Platelet function tests must not be drawn with a butterfly set or in “short draw” light blue top tubes. 13 Microbiology Specimen Collection and Handling Introduction The ability to assess the clinical significance of microbiology laboratory results is dependent upon proper specimen collection, preservation and transport. There is a wide variety of microorganisms found on the body naturally as “normal flora”. Specimen collection and preservation procedures are designed to avoid normal flora, if possible, or to at least keep their numbers low. Mid America Clinical Laboratories has produced a color pictorial “Microbiology Specimen Transport Guidelines” chart to assist in choosing the appropriate device. Sensitivities Antimicrobic susceptibilities are performed as a reflex test on appropriate organisms, whether or not a susceptibility is specifically requested. Susceptibility tests are not performed on normal flora, on isolates that have predictable sensitivity patterns, such as beta hemolytic streptococci, or on anaerobes. Most isolates are held for seven days and special requests can usually be accommodated. Please contact the Microbiology Department at (317)803-0050 concerning these requests. Specimen Site When submitting a specimen, please be specific about the site of the specimen. Do not use terms such as “wound”, “swab”, “fluid”, “tissue”, etc. For example, use the term “abdominal wound”. This gives the laboratory a much better idea of appropriate methods to use to grow the organisms expected as normal and as pathogenic from that area of the body. Microbiology Reports Reports are generated daily on routine cultures and weekly on fungus and acid-fast (AFB) cultures. Fungus cultures are examined for four weeks and AFB cultures for six weeks before reporting as negative. Unacceptable Specimens Unacceptable specimens may result in test cancellation or delay. The following is a list of the most common rejection criteria. 1. Mislabeled or unlabeled specimen and/or test request form. 2. Source not stated on test request form. 3. Inappropriate specimen for culture requested (such as an anaerobic culture request on a sputum specimen). 4. Improper specimen container or transport media. 5. Specimen too old (length of time varies with specimen source). 6. Specimens received in expired transport containers. 7. Urine contaminated with stool. 8. Stool contaminated with urine. 9. Diapers with absorbed stool. 10. Viral cultures collected with calcium alginate or wooden shaft swabs. 14 11. Tissue specimens in formalin. 12. Urine transport tube not filled to minimum line. Specimens for Anaerobic Culture Specimens for anaerobic culture must be transported in a container appropriate for the preservation of anaerobes. These transporters generally contain gel. The following specimen types are not appropriate for anaerobic culture due either to the presence of normal anaerobic flora or to the rarity of anaerobic infections from the specimen site. 1. Boil, pustule, decubitus and other superficial wounds 2. CSF 3. Nose, throat swabs 4. Sputum and bronchoscopic specimens (unless obtained by double lumen technique) 5. Feces and rectal swabs, except for Clostridium difficile cultures 6. Voided or catheterized urine 7. Vagina, cervical, urethral swabs As a general rule, aspirated fluid or tissue is preferable to a swab. Deep sites are the typical sites for recovery of anaerobes. Specimens for Viral Culture 1. Always include source of specimen and, when appropriate, type of infection and/or virus expected. 2. Recovery of virus is improved if the specimen is collected in the acute stage of the illness. 3. Viral, chlamydia, mycoplasma, ureaplasma transport media is available from the laboratory. M4 media is useful for recovery of any of these organisms. M4RT media is acceptable for viral culturing and testing only. 4. Collection of specimens for viral culture: a. Respiratory specimen 1) Viruses responsible for respiratory illness in a conscious patient may be collected for viral culture simply with a throat swab. Swab the posterior region of the pharynx with a sterile dacron swab. Do not use a calcium alginate or wooden shafted swab, which may be inhibitory to certain viruses. Break the swab into a viral transport tube immediately after collection. Cap the tube securely and label it. Place the tube in a plastic bag for transport to the laboratory. 2) b. For an RSV EIA test, nasal washings are preferred. Send nasal washings in a viral transport tube. Urine specimen. Collect a clean catch midstream (CCMS) or freshly catheterized urine into a sterile urine cup. Deliver the specimen to the laboratory promptly or refrigerate until delivery. c. Skin lesion specimen. 15 The preferred specimen for skin lesion is an aspirate from a fresh lesion via a 26 or 27 gauge needle attached to a tuberculin syringe. Expel the aspirated fluid immediately into a viral transport tube and cap securely. Label the tube. If the lesion cannot be aspirated, apply a sterile dacron swab to the lesion and rub vigorously. Break the swab into a viral transport tube and cap securely. d. Tissues or biopsies. Collect fresh tissue from an appropriate site using sterile technique. Each specimen need not be more than 1-2 cm. in diameter. Place in viral transport media. e. Feces/rectal swab. Collect feces in a clean container. Transfer sufficient feces to viral transport vial to make a 20-40% suspension. For rectal swab, insert swab(s) at least three centimeters into anal orifice. Rotate to ensure sufficient fecal specimen on swab. Break swab tip(s) off into viral transport vial. f. Cerebrospinal fluid. If less than 1 ml, send in CSF collection tube. If 1-2 ml, send in viral transport media. g. 5. Blood and serum Except for cytomegalovirus and enteroviruses, blood and serum are usually not productive specimen sources for the isolation of viruses. For isolation of cytomegalovirus from white blood cells (buffy coat), submit fresh blood in heparin. Send 7 ml whole blood at room temperature. DO NOT REFRIGERATE. For isolation of enteroviruses from serum (newborns and young children), collect one red-top tube of blood. Separate serum and submit in a plastic screw capped vial. Refrigerate specimens at 2-8º C (except CMV culture from buffy coat) immediately after collection. Do NOT freeze. 16 VIROLOGY Guidelines for Specimen and Test Selection • For detailed instructions on specimen collection, see previous section. • Refer to the General Test Listing section for test selection. • Preferred specimen type listed below in bold type. Disease or Syndrome Suspected Agents Clinical Specimens Cardiac Pericarditis/Myocarditis Myocarditis Pleurodynia Enterovirus, Influenza, Adenovirus, Parainfluenza, HSV, CMV Enterovirus Pericardial Fluid, Stool (only for Enterovirus), Throat Swab (HSV) Stool, Pleural Fluid, Throat Swab Exanthema and Rashes Chickenpox Zoster (Shingles) Herpes Simplex Herpangina Varicella-Zoster Varicella-Zoster Herpes Simplex Virus (HSV) Echovirus, Coxsackie A Vesicle Swab, Throat Swab Vesicle Swab Vesicle Swab Vesicle Swab, Stool, Throat Swab Adenovirus, Varicella-Zoster, Chlamydia trachomatis Adenovirus, HSV Conjunctival Swab Conjunctival Swab, Corneal Scraping Rotavirus, Adenovirus 40/41, Enterovirus For Antigen Testing Only Stool, Rectal Swab Enterovirus, HSV, Mumps Enterovirus, HSV, VaricellaZoster CSF, Stool (only for Enterovirus), Throat Swab CSF, Stool (only for Enterovirus), Throat Swab Cytomegalovirus (CMV), HSV HIV CMV HSV Chlamydia trachomatis, CMV Chlamydia trachomatis Urine (only for CMV), Throat Swab, CSF, Orifice Swab Blood (PCR testing only) Urine, Throat Swab Vesicle, Mouth, Eye, Throat or Ear Swab, CSF (if indicated) Respiratory Aspirate, Nasopharyngeal or Throat Swab Conjunctival Swab Influenza, Parainfluenza Adenovirus, Enterovirus, Respiratory Syncytial Virus (RSV) Nasopharyngeal (NP) Aspirate, NP Swab, Throat Washing or Swab, Sputum, Bronchial Washing, Bronchoalveolar Lavage Sexually-Transmitted Diseases Cervicitis Epididymitis Nongonococcal Urethritis Pelvic Inflammatory Disease Lymphogranuloma Venereum (LGV) Perianal Infection Herpes Chlamydia trachomatis, HSV Chlamydia trachomatis, HSV Chlamydia trachomatis, HSV Chlamydia trachomatis, HSV Chlamydia trachomatis Chlamydia trachomatis, HSV, CMV HSV Condyloma Human Papillomavirus Cervical Dysplasia and Carcinoma Human Papillomavirus Endocervical Swab, Genital Tissue (biopsy) Urethral Swab Urethral Swab, Genital Tissue (biopsy) Endocervical Swab, Genital Tissue (biopsy) Lymph Node Aspirate, Endocervical Swab, Lesion Swab Perianal or Rectal Swab Lesion Swab; Vesicular Fluid; for Asymptomatic Shedding Endocervical Swab with a Vulvar Sweep Endocervical Swab, Genital Tissue Biopsy (For nucleic acid probe only) Endocervical Swab, Genital Tissue Biopsy Eye Infections Conjunctivitis Keratitis Gastrointestinal Diarrhea Nervous System Aseptic Meningitis Encephalitis Perinatal Infections “Failure to Thrive” Cytomegalic Inclusion Disease Herpes Pneumonitis Conjunctivitis Respiratory Upper and Lower Respiratory Infections (including Pharyngitis, Croup, Bronchiolitis, Viral Pneumonia, and Influenza) 17 Blood Culture Collection 1. Labeling Label all culture bottles with the patient’s name, date and collection time, phlebotomist’s initials, and site of draw. 2. Timing We recommend the following guidelines for the timing of the collection of blood cultures and optimal recovery of microorganisms present. Before the use of systemic antimicrobials, obtain two separate sets of blood cultures. Most often, two separate sets of blood cultures will suffice. More may be required to confirm certain suspected diagnoses. Systemic and Localized Infections ▪ Suspected acute sepsis, meningitis, osteomyelitis, arthritis, or acute, untreated bacterial pneumonia: Obtain two sets of blood cultures. ▪ Fever of unknown origin: Initially, obtain two sets of blood cultures; 24-36 hours later obtain two additional sets of blood cultures. Note: The yield beyond four sets of blood cultures is often negligible. ▪ Suspected early typhoid fever or brucellosis: Owing to the low-grade bacteremia present in these infections, obtain four sets of blood cultures (the same venipuncture site may be used) over a 24-36 hour period. Infective Endocarditis Acute: Obtain three sets of blood cultures during the first 1-2 hours of evaluation. Subacute: Obtain three sets of blood cultures on the first day (ideally 15 or more minutes apart, the same venipuncture site may be used). If all three sets are negative, obtain two additional sets of cultures. Culture-negative endocarditis: Consult with the Medical Director, and/or local medical staff after five negative sets of blood cultures. Special culture techniques may be advised. 3. Blood Culture Bottles Since these cultures are processed using special media and instrumentation, it is necessary to submit all of these cultures in the Biomerieux aerobic (green) and anaerobic (orange) bottles supplied by Mid America Clinical Laboratories. For children, use a Biomerieux pediatric bottle (yellow). 4. Phlebotomy for Blood Cultures After palpation, scrub the venipuncture site with 70% alcohol or a blood culture skin prep device for a minimum of 30 seconds. Allow to air dry. ▪ Apply iodine/iodophor (1-2% tincture of iodine or 10% povidone-iodine) for 60 seconds in concentric circles away from the venipuncture site covering an area 1 ½ - 2 inches in diameter. After the puncture site has been decontaminated, do not touch. ▪ Decontaminate the diaphragm bottle tops by swabbing with 70% alcohol. Allow it to dry. Do not use iodine on the diaphragm tops. ▪ Using a syringe and needle or a “butterfly” double needle collection system, perform venipuncture and obtain 20 mL of blood (if an adult patient), 10 mL of blood (if a pediatric patient weighing 30-80 lbs.) and inoculate bottles as described below. ▪ Following venipuncture, remove iodophor that can irritate the skin of patients with 70% alcohol and allow to evaporate. ▪ Do not overfill bottles. Greater than 12 mL in the adult bottles and greater than 5 mL in the pediatric bottles constitute overfills. 18 5. Blood Culture Volumes Adult: Inoculate 10 mL each into Aerobic and Anaerobic bottles. If you cannot obtain 20 mL of blood, divide as follows: ▪ Less than or equal to 8 mL: transfer entire amount to Aerobic bottle. ▪ Greater than 8 mL, but less than 20 mL: transfer 8-10 mL to Aerobic bottle and the remainder to Anaerobic bottle. Pediatric Patients weighing 30-80 lbs: If you cannot obtain 10 mL of blood, divide as follows: ▪ Less than or equal to 5 mL: transfer entire amount to a Peds bottle. Throat Specimen Collection 1. Have the patient sit in an upright position. 2. Ask the patient where their throat hurts most. If the patient is a child that appears to be resistant, it may be helpful to allow the child to sit on the adult’s lap and instruct the adult to restrain the child’s arms from grabbing the swab. 3. Instruct patient to open mouth and stick out their tongue. 4. Use the tongue depressor to hold the tongue down. 5. Put the swab all the way to the back of the throat, rub in the area of the tonsils and behind them, making sure to touch area the patient says hurts. Move the swab up and down. Touch any white patches in the tonsillar area. 6. Do not rub the roof of the mouth or the tongue. 7. The swab must be saturated for accurate testing. 8. Label the culturette with the patient information. Date, time and initial the specimen. Label the specimen with the source of the collection (throat). Urine Culture Collection Submit specimens in urine culture transport tubes. 1. Patient Collection Guidelines: Clean Catch Midstream (CCMS) Females: 1. Wash hands using soap and water. 2. Open the collection cup. Do not touch the inside of the cup or the lid. 3. Spread the outer portion of the urinary area and hold apart for collection. 4. Use three wipes to clean the area. 5. Wipe one side, front to back, with first wipe. 6. Wipe other side, front to back, with second wipe. 7. Wipe the center, with third wipe. 8. Urinate into the toilet for a few seconds and stop. 9. Continue to urinate into the cup. 10. Replace the lid on the container. Screw the lid on tightly to prevent leakage. 11. Wash hands. 19 Males: 1. Wash hands using soap and water. 2. Using one of the antiseptic wipes, clean the end of the penis. Retract the foreskin if needed. 3. Repeat using second wipe. 4. Open the collection cup. Do not touch the inside of the cup or the lid. 5. Urinate into the toilet for a few seconds and stop. 6. Continue to urinate into the cup. 7. Replace the lid on the container. Screw the lid on tightly to prevent leakage. 8. Wash hands. 2. Collection Guidelines: Indwelling Catheter. Obtain the specimen with a needle and syringe. Select the puncture site 1-2 inches away from the catheter tube entry point. Cleanse the area to be punctured with 70% alcohol. Aspirate exactly 5 mL of urine with a sterile needle and syringe. Disinfect the rubber stopper and aseptically transfer the specimen to the urine transport tube provided. Specimens obtained from the collection bag are not suitable for analysis. Foley tips will not be accepted. 3. Urine Culture Transport Prevention of contamination by normal vaginal, perineal, and anterior urethral flora is the most important consideration for collection of a clinically relevant urine specimen. (See guidelines above for collection of a urine specimen.) Unpreserved urine is an excellent growth medium for most bacteria. Unless urine is preserved during transport, bacteria may multiply, causing colony counts to be erroneously high. The maintenance medium in the transport kit prevents rapid multiplication of bacteria in the urine during shipment. Send urine for culture in a gray topped urine tube. Instructions for use: a. Obtain the urine specimen. b. Open the pouch and remove the transfer device and tube. c. Submerge the straw of the transfer device to the bottom of the urine container. The container may be tipped at an angle if the volume of urine is limited. d. Place the transport tube in the holder portion of the transfer device and push it down as far as it will go, puncturing the stopper. e. Hold the tube and transfer device in position until the urine stops flowing into the tube. f. Remove the transport tube from the transfer device and shake the tube vigorously. g. Discard the transfer device and remaining cup of urine into appropriate biohazard disposal containers. Precaution: The transport tube must be filled to the minimum line indicated on the tube. A tube which is not filled at least to this line is unacceptable for culture. Sputum Specimen Collection Collect by instructing the patient to remove dentures, rinse mouth, gargle with water and cough deeply, expectorating into appropriate collection container. All specimens labeled “sputum” that are consistent with saliva will be rejected. Rejection is based on observation of cells on a gram stained smear. Stool Specimens 20 Specimens should be submitted in transport media suitable for the test(s) ordered. See individual test listing and the “Microbiology Specimen Transport Guidelines” chart for specific requirements. Wound Specimen Collection (wound, abscess, burn, exudate) 1. The specimen of choice depends on the extent and character of the infection. An aspirate is always preferred to a swab. A dry swab usually yields results of poor quality. 2. The methods for collection of wound and other skin and tissue collections are as follows: a. Unruptured abscess: Do not swab. Decontaminate the skin and aspirate contents with a syringe. If possible, submit a portion of the abscess wall after draining the abscess. Submit the specimen in an anaerobic transport container. b. Open lesions: Remove as much of the superficial flora as possible by decontaminating the skin with skin disinfectant. Remove exudate and sample the margin of the wound using a swab and firm pressure. Do not request anaerobic culture on open, superficial lesions. 3. Be as specific as possible in giving a specific anatomic source. “Wound”, “abscess” or “swab” is too general. 4. Transport the specimen to the lab as quickly as possible. 21 Cytopathology Specimen Collection and Handling Specimen Collection and Handling The essence of a successful Cytopathology program depends on both the physician and the laboratory. Obtaining the patient’s medical history, and a properly fixed, adequate specimen is essential. A final report, using descriptive Cytopathology terminology and an accurate interpretation are required to assure appropriate follow-up. Cytopathology services are offered in partnership with Ameripath of Indiana. Supplies We strongly recommend the use of our collection materials (Cytopathology Test Requisitions, liquid-based collection vials, slides, fixatives, endocervical brushes, brooms, spatulas and slide containers). Ordering Information Complete a Cytopathology test requisition including: ▪ Patient’s first and last name, social security number or unique identifier and date of birth ▪ Date of specimen collection ▪ Source of material submitted (cervical, endocervical, vaginal, or other gynecologic or non-gynecologic site) ▪ Submitting physician’s name, UPIN and telephone number For GYN Specimens: ▪ Last menstrual period (LMP) ▪ Pertinent clinical information (pregnant, postpartum, hormone therapy, oral contraceptives, hysterectomy, postmenopausal, pelvic radiation, etc.) ▪ History of abnormal cytology, gynecologic surgery, cryosurgery, high risk positive HPV For Non-GYN Specimens: ▪ Source and specific site (left, right, quadrant, etc.) ▪ Nature of lesion (solid/cystic, mobile/fixed, functional/non-functional, etc.) ▪ Any other pertinent history (previous surgery, presence of other masses, previous abnormal findings) ▪ Mammographic, X-ray or other imaging findings Specimen Identification We cannot accept specimens that are not properly labeled per Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. ▪ Label all slides on frosted end in pencil with patient’s first and last name or unique identifier. ▪ Label specimen containers (on the container wall, not the lid) with the patient’s first initial and full last name or unique identifier and site(s) of specimen collected. Unacceptable specimens*, with rare exception, will be rejected. *Unacceptable Specimens are defined as: ▪ No patient identification on test requisition 22 ▪ No patient identification on slide or specimen container (Labeling the slide holder only is not adequate identification.) ▪ No account/physician number or name and none available ▪ Slides broken beyond repair ▪ Specimen leaked from container ▪ Mismatch between name of patient on specimen and name on test requisition ▪ Inappropriate or incomplete test requisition ▪ Syringe with needle attached Specimen Collection Gynecologic Patient Preparation ▪ Patient abstains from sexual intercourse for 48 hours prior to the examination ▪ Patient abstains from using vaginal medication, vaginal contraceptives, lubricants, or douches for 24-48 hours prior to the examination ▪ The optimal time for a Pap test is mid-cycle. Menses may interfere with Pap test interpretation Note: DO NOT USE lubricant on the speculum. The speculum may be moistened with warm water if desired. The use of lubricant may contribute to an increased incidence of unsatisfactory Pap tests. Lubricants may contain ingredients known as “carbomers” or “carbopol polymers” that interfere with liquid-based Pap tests by causing immiscible agglutination of cells. Image Assisted ThinPrep® Pap Test/ThinPrep® Pap Test Brush / Spatula Device 1. Complete the test requisition. 2. Record the patient’s first and last name or unique identifier on the vial. 3. Obtain an adequate sampling from the ectocervix using a plastic spatula. 4. Immediately rinse the spatula in the PreservCyt® Solution vial by swirling vigorously in the vial 10 times, forcibly removing cells by scraping the spatula against the container if necessary. Discard the spatula. Do not let the spatula sit in the vial. 5. Obtain an adequate sampling from the endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottom-most fibers are exposed. Slowly rotate 180° clockwise. DO NOT OVER-ROTATE. 6. Rinse the brush in the PreservCyt® Solution by rotating the device in the solution 10 times while pushing against the PreservCyt® vial wall. Swirl the brush vigorously to further release material. If material is still visible on the bristles, then scrape the bristles with the spatula staying within the fluid. Swirl the brush vigorously to further release material. Discard the brush. Do not let the brush sit in the vial. 7. Tighten the cap so that the torque line on the cap passes the torque line on the vial. 8. Place the vial and requisition in a specimen bag for transport to the laboratory. Broom-like Device 1. Complete the test requisition. 2. Record the patient’s first and last name or unique identifier on the vial. 23 3. Obtain an adequate sampling from the cervix using a broom-like device. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently, and rotate the broom in a clockwise direction five times. 4. Rinse the broom in the PreservCyt® Solution vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. Swirl the broom vigorously to further release material. If material is still visible on the bristles, then scrape the bristles against the vial staying within the fluid. Swirl the broom vigorously to further release material. Discard the collection device. Do not let the broom sit in the vial. 5. Tighten the cap so that the torque line on the cap passes the torque line on the vial. 6. Place the vial and requisition in a specimen bag for transport to the laboratory. Specimen Collection Non-Gynecologic Fixatives: Appropriate fixatives for non-gyn cytology specimens include: ▪ CytoLyt® ▪ 95% ethyl alcohol ▪ Isopropyl or methyl alcohol may be used as a substitute if none of the above fixatives are available. ▪ Tissue Transport Media for possible flow cytometry analysis for lymphoma Smear (NOTE: Aspiration of cyst contents should be submitted as fluids, and not smears.) 1. Complete test requisition. 2. Write patient’s first and last name or unique identifier in pencil on frosted end of slide. 3. Submit 2-6 slides of material from any source that can be evaluated cytologically. 4. Immerse slides in 95% ethanol immediately after smearing. 5. Transport in ethanol containing slide vials. Fluid 1. Complete test requisition 2. Place fluid into 10 ml of CytoLyt®. Specimens greater than 10 mL should be fixed with a volume of fixative equal to the volume of the specimen. 3. Place fluid/fixative mixture in a tightly capped, leak-proof, labeled container (label the container wall, not the lid). a. Syringes are not acceptable specimen containers. b. Transportation of specimens with attached needles violates Department of Transportation Federal regulations, 49CFR173. Source Submission Requirements Breast Cyst Aspiration Mix material with an equal volume of fixative (see Fixatives). Breast Solid Mass Aspiration See Fine Needle Aspiration Biopsy below. Breast Secretion (Nipple Discharge) Drops of fluid from the nipple are smeared directly on clean glass slides and immersed immediately in alcohol. Do not remove the slides from the fixative. Send in alcohol transport container. 24 Bronchial Brushings Roll brush(es) over clean, dry slide(s). Fix immediately with alcohol. The brush(es) used to prepare bronchial brushing slides may be swirled in a container of appropriate fixative to dislodge additional specimen. Submit slides and liquid specimen together with one test requisition. Bronchial Washings Mix with an equal volume of fixative or put specimen in at least 10 mL of fixative if specimen is less than 10 mL volume. Effusions Mix material with an equal volume of fixative (see Fixatives). Endometrial Washings Mix material with an equal volume of fixative (see Fixatives). Esophageal Brushings Roll brushes over clean, dry slides. Immerse immediately in 95% ethanol. The brush(es) used to prepare slides may be swirled in a container of appropriate fixative to dislodge additional specimen. Submit slides and liquid specimen together with one test requisition. Esophageal Washings Mix material with an equal volume of fixative (see Fixatives). Fine Needle Aspiration Biopsy, (FNA) (Solid Lesion) FNA Slide Technique – Preferred Method 1. Label 6 glass slides with the patient’s first and last name or unique identifier on the frosted end prior to starting the procedure. Include the site, if there is room on the slide. 2. If local anesthetic is used, infiltrate into the region, avoiding possible contamination of the actual nodule. 3. Attach a 23 or 25 gauge needle to a syringe. 4. Insert needle into lesion. 5. While applying negative pressure, move needle back and forth traversing the entire lesion. 6. Release negative pressure, then remove needle. Specimen should not be drawn up into the barrel of the syringe. Pressure should be released as fluid appears in the needle hub. The cells and tissue fragments obtained from a solid lesion should remain in the hub. 7. After withdrawing the needle, eject one drop of specimen onto a slide. 8. Use another slide to smear the aspirated material. 9. Fix one of the pairs of slides immediately by immersion in 95% alcohol. 10. Leave one slide to air dry and submit this slide labeled “air dried.” 11. This procedure should be repeated 3-6 times, using a sterile syringe and needle each time, until the lesion has been thoroughly sampled. 12. If excess blood, fluid or cellular material is obtained with a needle pass, the excess should be expressed into a container of CytoLyt® or other cytology fixative. The container should be labeled with the patient’s First Initial and Full Last Name or unique identifier. The needle and syringe should be rinsed with 25 this same fixative. Submit the liquid specimen with the fixed and air-dried slides using one test requisition. Fine Needle Aspiration Biopsy, (FNA) (Solid Lesion) FNA Liquid-based Fixative Technique (Alternate Method) 1. Label container of CytoLyt® or other cytology fixative with the patient’s first and last name or unique identifier prior to starting the procedure. 2. If local anesthetic is used, avoid contaminating the site of the nodule. 3. Attach a 23 or 25 gauge needle to a syringe. 4. Insert needle into lesion. 5. While applying negative pressure, move needle back and forth traversing the entire lesion. 6. Release negative pressure, then remove needle. Specimen should not be drawn up into the barrel of the syringe. Pressure should be released as fluid appears in the needle hub. The cells and tissue fragments obtained from a solid lesion should remain in the hub. 7. Eject specimen directly into container of CytoLyt® or other cytology fixative. The container should be labeled with the patient’s first and last name. 8. Flush needle and syringe with fixative. 9. This procedure can be repeated multiple times, using sterile syringe and needle each time, until the lesion has been thoroughly sampled adding material obtained with each aspiration to the same container of fixative. Gastric Brushings Roll brush(es) over clean, dry slide(s). Fix immediately with alcohol. In order to dislodge additional cells, swirl the brushes used to prepare the slides in a container of fixative labeled with the patient’s first and last name or unique identifier. Submit slides and liquid specimen together with one test requisition. Gastric Washings Mix material with an equal volume of fixative (see Fixatives). Lymph Node (Touch Prep) Fix immediately in alcohol or air dry. Air-dried slides should be labeled as such. Paracentesis (Abdominal Fluid) Mix material with an equal volume of fixative (see Fixatives). Pericardial Fluid Mix material with an equal volume of fixative (see Fixatives). Pneumocystis jiroveci (previously Pneumocystis carinii) Bronchoalveolar lavages are preferred specimens. Bronchial washing, brushings or sputum may be submitted, but diagnostic yield is less. Mix material with an equal volume of fixative (see Fixatives). Fix submitted smears by immersing immediately in alcohol. Submit a minimum of 2 slides. Use pencil to label frosted end of slide with patient’s first and last name or unique identifier. Write “Evaluate for Pneumocystis” on test requisition. Skin (Viral) Lesions Remove crust or dome from lesion. Scrape ulceration with a brush or 26 curette. Spread material on a slide. Fix slides immediately by immersing in alcohol. Submit specimen in the alcohol container. Sputum Submit early morning deep-cough specimen prior to any food ingestion. Have patient rinse mouth with plain water before sputum is collected. Collect separate specimens on 3 consecutive mornings. Do not pool specimens. Mix material with an equal volume of fixative. Thoracentesis (Pleural or Chest Fluid) Mix material with an equal volume of fixative (see Fixatives). Urine (Bladder/Kidney, Voided) Submit all specimens in an equal volume of fixative (see Fixatives). Mark test requisition “Voided” or “Catheterized” as applicable. Urine Collected at Home 1. Provide patient with an appropriate volume of fixative (e.g., 50 mL Of alcohol or pre-measured container of CytoLyt®). 2. Instruct the patient to drink three (3) 8-oz. glasses of water before bedtime. 3. Have patient collect the second a.m. urine specimen and mix an equal volume with the fixative. Do not submit a 24-hour urine collection for cytologic evaluation. For any additional questions about Non-Gyn collection, requisitions, supplies or test results, please call (317)275-8000. 27 Reflex Testing Test Ordered Adrenal Antibodies TL Code Result (Reflex Criteria) 4645 Positive AFB Culture 4554 All orders, except CSF AFB Stain 4503 All orders Second or Confirmatory Test Adrenal Antibody Titer AFB stain, due to need for rapid information AFB culture, due to low sensitivity of AFB stain TL Code 36155% 4503 4554 Acetylcholinesterase Fetal Hemoglobin %4929 36208 ANA Titer & Pattern %36209 AFP, Amniotic Fluid 232 MoM >1.9 ANA Screen 249 1:40 or higher Anaerobic Culture 4469 All Orders Anticardiolipin Antibodies: IgA 4661 >22 or < 40 APL anti ß2 Glycoprotein IgA %59309 Anticardiolipin Antibodies: IgG 4662 >23 or < 40 GPL anti ß2 Glycoprotein IgG & IgM %59310 Anticardiolipin Antibodies: IgM 4663 >11 or < 40 MPL anti ß2 Glycoprotein IgM & IgM %59310 Anti-HCV 8472 Reactive with Low Signal/Cutoff Ratio Antireticulin Antibody 37520 Positive Aspirated or deep wound specimen received for aerobic culture 4550 All orders As Ordered Any Specimen Submitted 36560 Positive Bronchial Alveolar Lavage (BAL) Coccidioides Antibody IgG Cryoglobulin 36562 Positive None 4550 SEE DOS All orders Various cultures Pathogens isolated Dilute Russell Viper Venom Test (DRVVT) 59177 Abnormal GC Chlamydia DNA Probe Screening 6919 Positive Gram Stain 497 CSF Specimen Hepatitis B Surface Antigen 8472 Positive Hepatitis B Core AB Total CSF, Deep Wound, Respiratory Cultures Culture 501 Borderline or Positive Hepatitis C as part of a Needlestick Profile None Reactive with Low Signal/Cutoff Ratio Hepatitis C Viral RNA, Quantitative Real-Time PCR 35645 > 7,000,000 IU/mL Homocysteine as part of a Thrombotic Profile 31789 > 13.0 India Ink 59215 CSF Specimens Gram Stain RIBA Antireticulin Antibody IgA Titer Anaerobic culture Cytology Coccidioides AB Complement Fixation Cyrocrit (calculation) Gram stain, due to CAP requirements 497 8739 Not available as a separate test 4469 Not available as a separate test 906 Not available as a separate test 497 Identifications and sensitivities for appropriate pathogens isolated None Dilute Russell Viper Venom Test ratio 59178 Chlamydia DNA Probe Genital GC DNA Probe Genital 8502 8501 Culture 4550 Confirmation 36204 Hepatitis B Core AB IgM 4848 Hepatitis C Viral RNA Qual PCR 34024 Extended Range Not available as a separate test Methylene Tetrahydrofolate Reductase 677 36165 Fungus Culture 59250 Legionella culture, due to low sensitivity of Legionella stain None Legionella Stain None All orders Image assisted PAP with expanded HPV 51183 ASCUS, ASC-H LSIL, HSIL HPV-HR 31532 Liquid based PAP with expanded HPV 51168 ASCUS, ASC-H LSIL, HSIL HPV-HR 31532 Lyme Disease Ab Scrn 6646 Abnormal Lyme Disease Antibogy IgG & IgM by Western Blot 8593 Mitochondrial Ab 259 Positive Mitochondrial Ab Titer 36205 Myocardial Ab 261 Positive Myocardial AbTiter 36156 Parietal Cell Ab 262 Positive Parietal Cell Ab Titer %36207 28 Test Ordered TL Code Result (Reflex Criteria) 59180% > 115 Platelet Function Test, Epinephrine (PFT) 59149 > 192 seconds Protein C Activity 1777 < 70 1779 < 50 PTT Lupus Anticoagulant (Within a Profile) 59311 Greater than reference interval (>41.8 currently) Q Fever Antibody (Includes Phases I and II, IgG and IgM) screen 37071 Positive 59360 Negative Throat culture, due to low sensitivity of rapid test 36125 Reactive RPR Titer Treponema Pallidum Antibodies 799 Reactive RPR Titer %36203 59151 No Sperm Seen Fructose %59342 Skeletal Muscle Ab 266 Positive Striated Ab Titer %36210 Smooth Muscle Ab 263 Positive Smooth Muscle Ab Titer 681 All orders 36568 Positive 883 > 22.0 Platelet Function Adenosine Diphosphate (Within a Profile) Protein S Activity Rapid Group A Strep Screen RPR (Dx) RPR (Monitor) Semen Analysis Stool for Ova and Parasites Teichoic Acid Antibody Thrombin Clotting Time (within a profile) Negative Trichomonas Prep 7909 Urinalysis 3020 Urinalysis, Culture if Indicated Urine Metabolic Screen and Quantitative Organic Acids von Willebrand Activity Not available as a separate test 4459 Positive leukocyte esterase, nitrites, hemoglobin, protein or other than clear Nitrate positive or leukocyte esterase positive, WBC >5/hpf Bacteria > trace Yeast Present Second or Confirmatory Test Platelet aggregation TL Code 59154 Platelet Function Adenosine Diphosphate %59180 Protein C Antigen 510.19 Protein S Antigen and Free S Antigen STACLOT ™ Q Fever Antibody (includes Phases I and II, IgG and IgM) titers %51023 %51022 %51027 38506, 38510, 38508, 38512 394 %36203 4112 %36206 Permanent stain (Trichrome) Not available as a separate test Teichoic Acid Antibody Titer Not available as a separate test Thrombin Clotting Time with Protamine Sulfate correction Trichomonas Culture %51014 3960 8563 Microscopic 395 Urine Culture Positive Not available as a separate test Urine Amino Acid Quantitation < 50% 29 von Willebrand Antigen %51024 Client Information Account Management Team As a client of Mid America Clinical Laboratories, a member of the Sales team of account representatives will be assigned to help manage the services received from our laboratory. The MACL account representative can be contacted directly or through the sales support team at our facility. Billing Several billing options are available to our clients. Client billing (billing to health care provider, physician or group practice), patient billing (billing to the patient at a home address) or third party billing (billing to insurers with whom MACL has a claims processing agreement) can be selected. In order for us to bill third parties, we must be provided with the patient’s complete billing information including the patient’s address and insurance information which may also include claims address, group or ID number. All medically appropriate diagnosis ICD-9 codes are also necessary in order for us to bill a third party. A copy of the patient’s insurance card should also accompany the order. Field Name Bill To Patient Name Date of Birth Sex Patient Social Security # Patient Phone # Name of Insured/Responsible Party if Other Than Patient Street Address of Insured Medicare/Medicaid # Relationship to Insured Insurance Co. Name Member/Insured ID # Group # Insurance Address Employer Name/Employer # Insured SS # If Not Pt. ICD9 Diagnosis Code Patient/Responsible Party Signature UPIN Referring Physician and/or Payors Fields the Physician Must Complete to Bill Their Account The Patient Medicare/Medicaid X X X X X X X X X X X X X X X X X X Insurance X X X X X X X X X X X X X X X X X X X X X X Payers (including Medicare) are focusing on medical necessity guidelines. Many payers require laboratories to include diagnoses (diagnosis, symptom, condition, complaint or problem) on every claim as documentation of medical necessity. Our focus is specifically on Medicare’s medical necessity guidelines. Diagnosis information must be furnished using the ICD-9-CM coding system. Centers for Medicare Services (CMS) guidelines indicate that the ultimate responsibility for providing correct ICD-9 codes lies with the ordering physician. All Medicare carriers have implemented Local Medical Review Policies that restrict the medical conditions under which Medicare payment for certain tests will be made. These policies define the medical conditions (diagnosis, symptom, condition, complaint or problem) or ICD-9 codes that establish the medical necessity of certain tests under which payment will be made. If a limited coverage test is ordered in conjunction 30 with a diagnosis code that is not included in the Medicare carrier’s predetermined list of diagnoses, Medicare will not pay for the test. Based on these policies, we must have the most specific ICD-9 diagnosis codes, rather than a descriptive diagnosis, for each test on each patient. Any diagnosis information submitted on our claims must be furnished by the ordering physician or his or her authorized staff, and must be consistent with the diagnosis information documented in the patient’s medical records for that date of service. If required diagnosis information (valid and specific ICD-9 codes) is missing or invalid on the test requisition, we must generally contact the ordering physician or his or her authorized staff to obtain this required information. When this happens, it is not unusual for patients to receive unnecessary and often confusing correspondence from Medicare, their insurance companies, our laboratory, and the physician’s office pertaining to medical necessity/diagnosis information. Providing all medically appropriate and specific ICD-9 diagnosis codes on ALL test requisitions that accompany the specimen to our laboratory (including electronically submitted requisitions) can help to: ▪ Prevent inconvenience for patients ▪ Reduce payment delays from insurance companies ▪ Prevent the inconvenience of having us contact the ordering physician’s office Medicare will only pay for services that are determined to be reasonable and necessary under section 1862(a)(1) of the Medicare Law. If Medicare determines that a particular service, although it would otherwise be covered, is not reasonable and necessary under the Medicare Program Standards, Medicare will deny payment for that service. These tests may be identified as “limited coverage” under the National Coverage Determinations or Local National Coverage Determinations, may have frequency limits, or may be performed using a test kit that is not currently approved by the Food and Drug Administration. By signing a valid Advance Beneficiary Notice (ABN), the patient or responsible party is confirming agreement to assume financial responsibility for payment of these tests. The following information must be marked and/or indicated for the ABN to be valid: • • • • Name of the test indicated Date of Service Option Box 1 or Option Box 2 checked. The Option box 1 indicates that the patient would like to receive the laboratory test and they understand that Medicare may or may not cover the test and the patient may be liable for the bill. Option box 2 indicates that the patient has declined the laboratory testing service. Patient’s Signature (patient must sign prior to receiving the service) CPT Codes (Current Procedure Terminology Codes) All requests for CPT codes are accompanied by the following CPT code disclaimer: The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed. It is the client’s responsibility to determine the appropriate coding when a client is billing a third party payor for services performed by MACL. Ordering Supplies Certain supplies necessary to collect and submit specimens for analysis by MACL are provided to customers as part of our testing services. Type and quantity of items must correlate to the tests submitted to MACL for testing. 31 Ordering supplies can be done from the Internet. Go to www.maclonline.com and select “Try our new online client supply request system” at the bottom of the screen. Follow the instructions. Supplies can also still be ordered by calling 317-803-1010 and selecting option 4. Instructions for Packaging Specimens and Test Requisitions 1. Complete the “Patient Information” and “Insurance Information” sections and check (√) which party will be responsible for payment in the “Bill To” section of the test requisition. Enter the ICD-9 diagnosis codes that reflect the patient’s diagnoses and provide medical justification for the tests ordered. 2. Collect the specimen(s) in proper transport container. (Refer to the test detail section of the Directory of Services for more information.) Ensure that all specimen container caps and lids are properly tightened to prevent leakage. 3. Fold the top copy (original) of the test requisition in half widthwise (top to bottom) with the patient’s name and bar code facing out. Retain the second copy for your files. 4. The specimen bag has two pouches. Place the specimen(s) in the rear pouch with the zip lock. Place the requisition in the front pouch with the bar code facing out. 5. Frozen specimens must be placed in a separate specimen bag along with a separate requisition. Frozen specimens cannot be split for other tests. Proper Specimen Packing Helps Expedite Your Order. 32 1 1 1 1 1 1 3 1 2 1 1 4 2 2 8 5 6 7 2 2 2 2 9 2 2 2 1 2 1 3 3 3 3 33 Test Requisition Definitions 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. Bar Code Section Contains the pre-assigned client and requisition numbers. Client Number Identifies your MACL client identification number. Requisition Number Identifies the specific patient order. Client Address Section Client name, address and phone appear here. Date Collected Indicate date specimen is collected. Time Indicate the collection time. Circle AM or PM. Total vol/hrs Indicate the total volume (ML) of specimen and the hours of collection (HR). Fasting Indicate by checking the box if fasting is applicable for this patient. U.P.I.N. Referring Physician and/or Payers Indicate the name of referring physician here. If the order is billed to Medicare, it must also indicate the physician’s U.P.I.N. number. This area may contain a combination of UPINs, Referring Physicians or Payers. When completing a Generic Test Requisition, every field on the sample requirement section must be completed or testing may be delayed. Call/Fax Results Check the box if results are to be called or faxed. Include the appropriate number(s), starting with the area code. Duplicate Report Fill in the complete name and address of physician(s) to receive duplicate report, or fill in an established client number, preceded by the # sign. Incomplete information will cause delays in test results reporting. Bill to Box In the Bill To box, check the box which indicates the type of billing requested: doctor’s office, insurance, patient. Patient Name Print last name and first name. Date of Birth Date of Birth—Month, Day, Year (MM DD YEAR). Sex Indicate M-Male F-Female Patient Social Security Number Indicate the patient’s social security number. Office/Patient ID Number Indicate any patient ID to be printed on the report or client bill. Patient Phone Number Indicate the patient’s phone number, starting with area code. Name of Responsible Party, if Other Than Patient Indicate the responsible party if other than the patient. Indicate last name, first name, and middle initial. Patient or Responsible Party Address Indicate the address of the patient or responsible party. Include the street address, apartment number (key number, if applicable), city, state and zip. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34 Relationship to Insured Indicate the relationship to insured by checking one of the following boxes? Self Spouse Dependent Insurance Company Name Indicate the name of the insurance company and insurance plan or product. Member/Insured ID Number Indicate the member or subscriber number as it is listed on the insurance card. Group Number Indicate the group number as it is listed on the insurance card. Insurance Address Indicate the insurance company’s address as it is listed on the insurance card. If there is more than one listed on the card, use the claims office address. Employer Name Indicate the patient’s or responsible party’s employer’s name and employer ID number. Insured Social Security Number Indicate insured social security number, if not the patient. Insured Birth Date Date of Birth—Month, Day, Year (MMDDYEAR) ICD-9 Diagnosis Code(s) Indicate all applicable codes in the boxes provided. Do not include descriptive diagnosis. ICD-9 codes are for billing purposes only and will not be considered as clinical history in the evaluation of Pap Smears. Advance Beneficiary Notice (ABN) Medicare will only pay for services that it determines to be reasonable and necessary under section 1862(a)(1) of the Medicare Law. If Medicare determines that a particular service, although it would otherwise be covered, is not reasonable and necessary under the Medicare Program Standards, Medicare will deny payment for that service. By signing an ABN, the patient or responsible party is confirming agreement to assume financial responsibility for payment of these tests. Tests identified on requisitions with an “@” are likely to be denied payment if the diagnosis does not meet the reimbursement rules. Those tests identified with “&” are likely to be denied because the test is non-FDA approved/experimental. Tests designated with “F” are likely to be denied for payment because Medicare will pay for screening with these tests but only once every twelve months. Tests marked with “B” have both diagnosis and frequencyrelated coverage limitations. Additional Tests Indicate all MACL Order Codes for additional tests required that are not preprinted on the Test Requisition; and/or indicate “STAT” if STAT testing is required. (Note: Additional fees will be assessed for this expedited service.) Physician Signature Physician signature required for Medicaid billing in specific states. Standing Order Information Need: Start date, stop date and frequency. Allergy Evaluations Individual Allergens Preferred Specimen: 1 mL serum from a red-top tube for 1-4 allergens tested, and at least 2 mL serum for each 5-10 allergens tested. Allergen Specific IgE Interpretation of Results Specific IgE Class 0 1 2 3 4 5 6 kU/L < 0.35 0.35-0.70 0.71-3.50 3.51-17.5 17.6-50 51-100 > 100 Level of Allergen Specific IgE Antibody Absent/Undetectable Low Level Moderate Level High Level Very High Level Very High Level Very High Level The individual allergens, represented with their Pharmacia CAP System® code in the following Tables may be ordered on an individual basis. These Tables are listed alphabetically by allergen. Alphabetical by Allergen Table 1 Animals Cat epithelia Chicken feathers Cow dander Dog dander Dog epithelia Duck feathers Goat epithelia Goose feathers Guinea Pig epithelia Hamster epithelia Horse dander Mouse epithelia Mouse serum proteins Mouse urine proteins Parrot/Parakeet droppings Parrot/Parakeet feathers Parrot/Parakeet serum proteins Pigeon droppings Rabbit epithelia Rat Rat epithelia Rat serum proteins Rat urine proteins Sheep epithelia Swine epithelia Pharmacia Code e1 e85 e4 e5 e2 e86 e80 e70 e6 e84 e3 e71 e76 e72 e77 e78 379 e7 e82 e87 e73 e75 e74 e81 e83 Test Code 2601 2651 2604 2605 2602 2664 2656 2661 2606 2652 2603 2657 6744 2658 2663 2662 2679 2607 2654 2538 2659 6778 2660 2655 2653 Alphabetical by Allergen Table 2 Biologics & Occupational Castor bean Cotton seed Green coffee bean Insulin, bovine Insulin, human Insulin, porcine Ispaghula (psyllium) Latex Silk Sunflower seed Wild silk Pharmacia Code k71 k83 k70 c71 c73 c70 k72 k82 k74 k84 k73 Test Code 2751 23862 2752 2755 2760 2754 2753 8927 2758 23864 2757 Pharmacia Code f202820 f762851 f492849 f237 f261 Test Code Table 3 Food Almond Alpha-lactalbumin Apple Apricot Asparagus 35 2563 2626 Avocado Banana Barley Basil Beef Beta-lactoglobin Black Pepper Blackberry Alphabetical by Allergen f968928 f928926 f6 f269 f272827 f772852 f280 f211 Honey Kiwi fruit Lamb Lemon Lentils Lettuce Lime Lobster Mackerel Malt 2806 2564 2561 2630 f247 f84 f88 f208 f235 f215 f306 f80 f206 f102 8930 2884 2888 2708 3010 2862 2709 2855 2713 2863 Table 3 (Continued) Food Blue mussel Blueberry Brazil nut Broccoli Buckwheat Cabbage Carrot Casein Cashew nut Cauliflower Celery Cheddar cheese Cheese, mold type Cherry Chestnut Chicken meat Chili Pepper Cinnamon Clam Cocoa Coconut Codfish Coffee Corn Crab Cucumber Egg Mix Egg white Egg yolk Eggplant Garlic Ginger Gluten Goat Milk Grape Grapefruit Green bean Green Pepper Halibut Hazel nut Pharmacia Code f372837 f288 f182818 f260 f112811 f216 f312831 f782853 f202 f291 f852860 f812858 f822859 f242 f299 f832857 f279 f220 f207 f932875 f362836 f3 f221 f8 f23 f244 f245 f1 f75 f262 f47 f270 f79 f30 f259 f209 f315 f263 f303 f17 Alphabetical by Allergen Test Code Table 3 (Continued) 2568 Food Mandarin Mango fruit Melons Milk Milk, boiled Mushroom Mustard Nutmeg Oat Onion Orange Oregano Oyster Papaya Paprika Parsley Passion fruit Pea Peach Peanut Pear Pecan Pine nut Pistachio Plum Poppy seed Pork Potato Rabbit Rice Rye Salmon Scallops Sesame seed Shrimp Soybean Spinach 2631 2632 2608 2635 2609 2636 2610 2637 8929 2803 2915 2808 2823 2639 2919 2801 2856 2642 2847 2644 2854 2922 2675 2923 2680 2931 2998 2817 36 Pharmacia Code f302 f91 f87 f2 f231 f212 f89 f282 f7 f48 f33 f283 f290 f293 f218 f86 f29 f12 f95 f13 f94 f201 f253 f203 f255 f224 f26 f35 f213 f9 f5 f41 f38 f10 f24 f14 f214 Test Cod 2714 23860 2887 2802 3044 8931 2889 2718 2807 2848 2833 3045 8932 2720 3047 2861 2724 2812 8405 2813 8884 2864 2725 2726 2728 3050 2826 2835 2730 2809 2805 2841 273 2810 2824 2814 3054 Squid Strawberry Sweet Potato Swordfish Tea Tomato Trout Tuna Vanilla Walnut Wheat White bean Yeast f258 f44 f54 f312 f222 f25 f204 f40 f234 f256 f4 f15 f45 2745 2844 2555 3055 6805 2825 3063 2840 3244 3489 2804 2815 2845 Table 6 Test Code 2317 2302 2311 2371 2307 3490 2314 2312 2315 2310 Alphabetical by Allergen Pharmacia House Dust Mites Code Dermatophagoides farinae d2 Dermatophagoides pteronyssinus d1 Glycyphagus domesticus d73 Lepidoglyphus destructor (Storage mite) d71 Test Code 2722 2721 2727 2723 Alphabetical by Allergen Table 4 Pharmacia Grasses Code Bahia grass (paspalum notatum) g17 Bermuda grass (nodon dactylon) g2 Brome grass (Bromus inemis) gil Canary grass (Phalaris canariensis) g71 Common reed (Phragmites communis) g7 Corn grass g202 Cultivated oat pollen (Avena sativa) g14 Cultivated rye grass (Secale cereale) g12 Cultivated wheat pollen (Tritica sativa) g15 Johnson grass (Sorghum halepense) g10 June grass (Kentucky Blue) (Poa pratensis) g8 2308 Meadow fescue (Festuca elation) g4 Meadow foxtail (Alopecurus pratensis) g16 Orchard grass (cocksfoot) (Dactylis glomerata) g3 Perennial rye grass (Latium perenne) g5 Red top grass (Bent grass) (Agrostis alba) g9 Salt grass (Distichlis species) g100 Sweet vernal grass (Anthoxanthum odoratum) g1 Timothy grass (Phleum pratense) g6 Velvet grass (Holcus lanatus) g13 Wild rye (Secale species) g70 Table 7 Insects Bloodworm Cockroach Green Nimitti midge Honeybee Imported fire ant Mosquito Paper wasp White-faced hornet Yellow hornet Yellow jacket 2304 2316 2303 2305 Pharmacia Code h1 h2 Test Code 2738 2736 2737 2731 2739 2740 2734 2732 2733 2733 Pharmacia Code m6 m3 m12 6647 3301 m208 m5 Test Code 2706 2703 6634 Table 8 Molds Alternaria alternata Aspergillus fumigatus Aureobasidium pullulans (Pullularia) Botrytis cinerea m7 C. acremonium m20 C. globosum Candida albicans Caldosporium herbarum (Hormodendrum) Cum/aira lunata Epicoccum purpurascens Fusarium moniliforme Helminthosporium halodes Mucor racemosus Pityrosporum orbiculare Penicillum notatum 2309 2350 2301 2306 2313 2370 Table 5 House Dust House dust (Greer) House dust (Hollister-Stier) Pharmacia Code i73 i6 i72 i1 i70 i71 i4 i2 i5 i3 Test Code 2711 2712 37 m2 m16 m14 m9 m8 m4 m70 m1 3415 2705 2702 6680 6692 6696 6711 2704 3403 2701 Phoma betae Rhizopus nigricans Stemphylium botyrosum T. rubum Trichoderma viride m10 m11 m10 m205 m15 6770 6781 6799 3406 6809 Table 10 Pharmacia Weeds Code Cocklebur (Xanthum pennsylvanicum) w13 Common ragweed (short) (Ambrosia elation) w1 Dandelion (Taraxacum vulgare) w8 English plantain (Plantago lanceolata) w9 False ragweed (Franseria acanthicarpa) w4 Firebush (Kochia scoparia) w17 Giant ragweed (tall) (Ambrosia trifida) w3 Goldenrod (Solidago virgaurea) w12 Lamb’s-quarters (goosefoot; Chenopodium album) w10 Mugwort (sagebrush) (Artemisia vulgaris) w6 Nettle (Urtria dioica) w20 Oxeye daisy (Chrysanthemum leucanthum) w7 Rough marsh elder (Iva) w16 Rough pigweed (Amaranthus retroflexus) w14 Russian thistle (prickly saltwort; Salsola kal.) w11 Scale (Atriplex) w15 Sheep sorrel (dock; Rumex acetosella) w18 Alphabetical by Allergen Table 9 Pharmacia Trees Code Acacia (Acacia species) t19 Alder (Alnus incana) t2 Australian pine (Casuarina equisetifolia) t73 Beech (Fagus grandifolia) t5 Birch (Betula verrucosa) t3 Chestnut t206 Test Code 2519 2502 2554 2505 2503 3417 Alphabetical by Allergen Table 9 (Continued) Pharmacia Trees Code Cottonwood (Populus deltoides) t14 Douglas fir t207 Elm (Ulmus americana) t8 Eucalyptus (Eucalyptus species) t18 Hazel nut (Corylus avellana) t4 Italian cypress (Cupressus sempervirens) t23 Maple (box elder; Acer negundo) t1 Melaleuca (Melaleuca species) t21 Mesquite (Prospus juliflora) t20 Mountain cedar (Juniperus sabinoides) t6 Oak (Quercus alba) t7 Olive (Olea europa) t9 Pecan/Hickory (Carya species, pecan) t22 Pine t213 Privet t210 Queen palm (Arecastrum romanzoffianum) t72 Spruce t201 Sweet gum t211 Sycamore (Plantanus acerfolia) tt11 Walnut (Juglans californica) t10 White ash (Fraxinus americana) t15 White mulberry (Morus species) t70 White pine (Pinus strobus) t16 Willow (Salixnigra) t12 Test Code 2514 3319 2508 2518 2504 2523 2501 2521 2520 2506 2507 2509 2522 3423 3326 Test Code 2413 2401 2408 2409 2404 2417 2403 2412 2410 2406 2420 2407 2416 2414 2411 2415 2418 Table 10 Weeds Western ragweed (Ambrosia psilostachya) Wormwood (sagebrush) (Artemisia absinthium) Pharmacia Code Test Code w2 2402 w5 2405 Table 11 Other Allergen Ascaris Echinococcus Seminal Fluid 2556 3426 3328 2511 2510 2515 2570 2516 2512 38 Pharmacia Code p1 p2 o70 Test Code 2741 2742 2770 Allergy Evaluations Allergy Profiles for Inhalant and Food Allergens A total of 19 regional allergy profiles have been developed based upon the regional prevalence of allergens, taking into account the relative abundance and antigenicity for each seasonal allergen. Each Regional Respiratory Allergy Profile consists of from 14-21 of the most prevalent tree, grass, and weed allergens specific to that region, in addition to the most prevalent allergens common to all regions. All Regional Respiratory Allergy Profiles include a Total IgE test. Testing is performed by the Pharmacia Diagnosis ImmunoCAP®1 Specific IgE blood test, which utilizes a fluoroenzyme immunoassay (non-RAST1) procedure that is more accurate than either RAST. This results in a high degree of diagnostic efficiency in the detection of atopic individuals relative to inhalant and food allergens. Submission requirements: 2 mL serum-plastic vial. Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens Test (Profile I: CT, MA, ME, NH, NJ, PA, RI, VT) (Profile II: DC, DE, MD, NC, VA) Prevalent Test Allergens Test Code d1 d2 e1 e5 g3 i6 m2 m3 m6 t1 t3 t7 t8 t15 w1 w10 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Orchard grass (cocksfoot; Dactylis glomerata) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumagatus Alternaria alternata (a mold) Maple (box elder; Acer negindo) Birch (Betula verrucosa) Oak (Quercus alba) Elm (ulmus americana) White ash (Fraxinum americana) Common ragweed (short; Ambrosia elation) Lamb’s-quarters (goosefoot; Chenopodium album) 10643 d1 d2 e1 e5 g2 g8 g10 i6 m2 m3 m6 t1 t7 t8 t22 w1 w10 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) June grass (Kentucky blue; Poa prentesis) Johnson grass (Sorghum halepense) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negindo) Oak (Quercus alba) Elm (Ulmus americana) Pecan/Hickory (Carya species, pecan) Common ragweed (short; Ambrosia elation) Lamg’s-quarters (goosefoot; Chenopodium album) 10644 39 Allergy Evaluations Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens (Continued) Test (Profile III: GA, northern F4 SC) (Profile IV: FL, south of Orlando) (Profile V: IN, KY, OH, TN, WV) Prevalent Test Allergens Test Code d1 d2 e1 e5 g2 g8 g10 g17 i6 m1 m2 m3 m6 t7 t8 t22 w1 w14 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) June grass (Kentucky blue; Poa prentesis) Johnson grass (Sorghum halepense) Bahia grass (asoakyn bitatyn) Cockroach Penicillum notatum Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Oak (Quercus alba) Elm (Ulmus americana) Pecan/Hickory (Carya species, pecan) Common ragweed (short; Ambrosia elation) Rough pigweed (Amaranthus retroflexus) 10285 d1 d2 e1 e5 g2 g17 i6 m1 m2 m3 m6 t7 t22 t73 w1 w14 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Bahia grass (asoakyn bitatyn) Cockroach Penicillum notatum Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Oak (Quercus alba) Pecan/Hickory (Carya species, pecan) Australian pine (Casuarina equisetifolia) Common ragweed (short; Ambrosia elation) Rough pigweed (Amaranthus retroflexus) 10286 d1 d2 e1 e5 g2 g8 g10 i6 m2 m3 m6 t7 t8 t10 t22 w1 w10 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) June grass (Kentucky blue; Poa prentesis) Johnson grass (Sorghum halepense) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Oak (Quercus alba) Elm (Ulmus americana) Walnut (Juglans californica) Pecan/Hickory (Carya species, pecan) Common ragweed (short; Ambrosia elation) Lamb’s-quarters (goosefoot; Chenopodium album) 10647 40 Allergy Evaluations Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens (Continued) Test (Profile VI: AL, AR, LA, MS) (Profile VII: MI, MN, WI) (Profile VIII: IA, IL, MO) Prevalent Test Allergens Test Code d1 d2 e1 e5 g2 g8 g10 i6 m1 m2 m3 m6 t7 t8 t10 t22 w1 w16 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) June grass (Kentucky blue; Poa prentesis) Johnson grass (Sorghum halepense) Cockroach Penicillum notatum Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Oak (Quercus alba) Elm (Ulmus americana) Walnut (Juglans californica) Pecan/Hickory (Carya species, pecan) Common ragweed (short; Ambrosia elation) Rough marsh elder (Iva) 10647 d1 d2 e1 e5 g3 g9 m2 m3 i6 m6 t1 t3 t7 t8 w1 w16 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Orchard grass (cocksfoot; Dactylis glomerata) Red top grass (Bent grass; Agrostis alba) Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Cockroach Alternaria alternata (a mold) Maple (box elder; Acer negundo) Birch (Betula verrucosa) Oak (Quercus alba) Elm (Ulmus americana) Common ragweed (short; Ambrosia elation) Rough marsh elder (Iva) 10648 d1 d2 e1 e5 g3 g8 i6 m2 m3 m6 t1 t3 t7 t8 w1 w16 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Orchard grass (cocksfoot; Dactylis glomerata) June grass (Kentudky Blue; Poa pratensis) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Birch (Betula verrucosa) Oak (Quercus alba) Elm (Ulmus americana) Common ragweed (short; Ambrosia elation) Rough marsh elder (Iva) 41 Allergy Evaluations Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens (Continued) Test Prevalent Test Allergens d1 d2 e1 e5 g2 g9 i6 m2 m3 m6 t1 t7 t8 t14 w1 w11 w16 w17 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Red top grass (Bent grass; Agrostis alba) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Oak (Quercus alba) Elm (Ulmus americana) Cottonwood (Populus deltoids) Common ragweed (short; Ambrosia elation) Russian thistle (prickly saltwort; Salsola kali) Rough marsh elder (Iva) Firebush (Kochia scoparia) (Profile X: OK, TX) d1 d2 e1 e5 g2 g8 g10 i6 m2 m3 m6 t6 t7 t8 t10 w1 w16 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) June grass (Kentucky Blue; Poa pratensis) Johnson grass (Sorghum halepense) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Mountain cedar (Juniperus sabinoides) Oak (Quercus alba) Elm (Ulmus americana) Walnut (Juglans californica) Common ragweed (short; Ambrosia elatior) Rough marsh elder (Iva) (Profile XI: AZ (mountains), CO, ID (mountains), MT, NM, UT, WY) d1 d2 e1 e5 g2 g9 i6 m2 m3 m6 t1 t2 t6 t7 t8 t14 w11 w17 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Red top grass (Bent grass; Agrostis alba) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Alder (Alnus incana) Mountain cedar (Juniperus sabinoides) Oak (Quercus alba) Elm (Ulmus americana) Cottonwood (Populus deltoids) Russian thistle (prickly saltwort; Salsola kali) Firebush (Kochia scoparia) (Profile IX: KS, NE, ND, SD) 42 Test Code 10650 10653 Allergy Evaluations Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens (Continued) Test (Profile XII: AZ (south), CA (southeast desert) (Profile XIII: CA, southern coast) Prevalent Test Allergens Test Code d1 d2 e1 35 g2 g5 i6 m2 m3 m6 t6 t9 t14 t15 t20 w11 w14 w15 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Perennial rye grass (Lolium perenne) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Mountain cedar (Juniperus sabinoides) Olive (Olea europa) Cottonwood (Populus deltoides) White ash (Fraxinus americana) Mesquite (Prospus juliflora) Russian thistle (prickly saltwort; Salsola kali) Rough Pigweed (Amaranthus retroflexus) Scale (Atriplex) 10654 d1 d2 e1 e5 g2 g11 g14 i6 m2 m3 m6 t1 t7 t9 t10 t11 t17 w4 w11 w14 w15 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Brome grass (Bromus inermis) Cultivated oat pollen (Avena sativa) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Oak (Quercus alba) Olive (Olea eruopa) Walnut (Juglans californica) Sycamore (Plantanus acerfolia) Japanese cedar False ragweed (Franseria acanthicarpa) Russian thistle (prickly saltwort; Salsola kali) Rough Pigweed (Amaranthus retroflexus) Scale (Atriplex) 10655 43 Allergy Evaluations Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens (Continued) Test (Profile XIV: CA, central valley) (Profile XV: ID (south), NV) Prevalent Test Allergens d1 d2 e1 e5 g2 g9 g14 i6 m2 m3 m6 t1 t2 t7 t9 t10 t17 w6 w10 w14 w15 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Red top grass (Bent grass; Argostis alba) Cultivated oat pollen (Avena sativa) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Alder (Alnus incana) Oak (Quercus alba) Olive (Olea eruopa) Walnut (Juglans californica) Japanese cedar Mugwort (sagebrush; Artemisia vulgaris) Lamb’s-quarter’s (goosefoot; Chenopodium album) Rough pigweed (Amaranthus retroflexus) Scale (Atriplex) d1 d2 e1 e5 g2 g9 i6 m2 m3 m6 t1 t2 t3 t9 t14 t70 w6 w11 w14 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Red top grass (Bent grass; Argostis alba) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Alder (Alnus incana) Birch (Betula verrucosa) Olive (Olea eruopa) Cottonwood (Populus deltoides) Mulberry Mugwort (sagebrush; Artemisia vulgaris) Russian thistle (prickly saltwort; Salsola kali) Rough pigweed (Amaranthus retroflexus) 44 Test Code 10668 Allergy Evaluations Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens (Continued) Test (Profile XVI: OR, WA (central and east) (Profile XVII: CA (northwest), OR (west), WA) (Profile XVIII: Alaska) Prevalent Test Allergens Test Code d1 d2 e1 e5 g9 i6 m2 m3 m6 t1 t2 t3 t7 t14 w6 w11 w14 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Red top grass (Bent grass; Argostis alba) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Alder (Alnus incana) Birch (Betula verrucosa) Oak (Quercus alba) Cottonwood (Populus deltoides) Mugwort (sagebrush; Artemisia vulgaris) Russian thistle (prickly saltwort; Salsola kali) Rough pigweed (Amaranthus retroflexus) 10657 d1 d2 e1 e5 g6 i6 m2 m3 m6 t1 t2 t3 t7 t10 w2 w11 w14 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Timothy grass (Phleum pretense) Cockroach Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Maple (box elder; Acer negundo) Alder (Alnus incana) Birch (Betula verrucosa) Oak (Quercus alba) Walnut (Juglans californica) Western ragweed (Ambrosia psilostachya) Russian thistle (prickly saltwort; Salsola kali) Rough pigweed (Amaranthus retroflexus) 10658 d1 d2 e1 e5 g11 g71 i6 m2 m3 m6 t2 t3 t14 w14 Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Brome grass (Bromus inermis) Canary grass (Phalaris canariensis) Cockroach Cladosporium herbarum (Hormodendrum) Indoor mold (Aspergillus fumigatus) Outdoor mold (Alternaria alternate) Alder (Alnus incana) Common silver birch Cottonwood (Populus deltoides) Rough pigweed (Amaranthus retroflexus) 45 Allergy Evaluations Table 1. Regional Respiratory Allergy Profiles for Inhalant Allergens (Continued) Test (Profile XIX: Puerto Rico) Table 2. Puerto Rico Dermatophagoides pteronyssinus Dermatophagoides farinae Cat epithelia Dog dander Bermuda grass (Cynodon dactylon) Bahia grass (Paspalum notatum) Cockroach Penicillum notatum (a mold) Cladosporium herbarum (Hormodendrum) Aspergillus fumigatus Alternaria alternata (a mold) Oak (Quercus alba) Eucalyptus (Eucalyptus species) Pecan/Hickory (Carya species, pecan) Queen palm (Arecastrum romanzoffianum) Australian pine (Casuarina equisetifolia) English plantain (Plantago lanceolata) Rough pigweed (Amaranthus retroflexus) Wall pellitory Test Code 38828 Childhood Allergy (Food and Environmental) Profile States 50 States d1 d2 e1 e5 g2 g17 i6 m1 m2 m3 m6 t7 t18 t22 t72 t73 w9 w14 w19 Prevalent Test Allergens Test Prevalent Test Allergens d2 e1 e5 f1 f2 f3 f13 f14 f4 i6 m6 Dermatophagoides farinae Cat epithelia Dog dander Egg white Milk Codfish Peanut Soybean Wheat Cockroach Outdoor mold (Alternaria alternate) d1 e1 e5 f1 f2 f8 f13 f14 f4 i6 m6 Total IgE Dermatophagoides farinae Cat epithelia Dog dander Egg white Milk Corn Peanut Soybean Wheat Cockroach Outdoor mold (Alternaria alternate) Total IgE 46 Test Code 10659 Allergy Evaluations Table 3. Food Allergy Profile, Adult States Test f1 f2 f3 f4 f8 f13 f14 f24 f207 f256 f338 50 States Prevalent Test Allergens Egg white Milk Codfish Wheat Corn Peanut Soybean Shrimp Calm Walnut Scallop Test Code 10715 Additional Allergy Panels Submission Requirements: Each of these panels, consisting of 5 allergens, may be determined from 2 mL Serum – Plastic vial. Mold Group #11 (Test Code 7911) m2 Cladosporium herbarum m3 Aspergillus fumigatus m4 Mucor racemosus m5 Candida albicans m6 Alternaria tenuis Vegetable Group #16 (Test Code 7916) f8 Corn f12 Pea f15 White bean f31 Carrot f35 Potato Animal Group #1s (Test Code 7912) e3 Horse dander e4 Cow dander e7 Pigeon droppings e70 Goose feathers e85 Chicken feathers Salad Group #17 (Test Code 7917) f25 Tomato f33 Orange f85 Celery f86 Parsley f215 Lettuce Stinging Insect Group #13 (Test Code 7913) i1 Honeybee i2 White-faced hornet i3 Yellow jacket i4 Paper wasp i5 Yellow hornet Nut Mix Group #18 (7918) f10 Sesame seed f13 Peanut f20 Almond f36 Coconut f201 Pecan Cereal Group #15 (Test Code 7915) f5 Rye f6 Barley f9 Rice f11 Buckwheat f79 Gluten NOTE: Seafood Group #19 (Test Code 7919) f3 Codfish f23 Crab f24 Shrimp f40 Tuna f80 Lobster A substitution will be made only when an individual allergen is unavailable. 47 This page intentionally left blank 48