Clinical Laboratory Partners Page A-1

Transcription

1

2 Test Codes As Of 12/19/2015

3 Accreditations CLIA D College of American Pathologists Connecticut Dept. of Public Health... CL-0385 Federal Tax ID Medicare ID (PTAN) New York State Department of Health... PFI 7988 Rhode Island Department of Health... LCO MEDICAID ID Call Values: Critical Clinical Laboratory Partners will call critical laboratory results to the ordering physician, or designee, as soon as possible once results become available. Calls will be made twenty-four hours a day, seven days a week, including weekends and holidays. Call Values: Urgent Clinical Laboratory Partners will call clinically significant (urgent) laboratory results to the ordering physician, or designee, as soon as possible once results become available. Urgent values will be called from 9:00am to 10:00pm seven days a week including weekends and holidays. Results not called before 10:00pm will be called the next morning beginning at 9:00am. Changes in Methodologies/Fees Clinical Laboratory Partners may deem it necessary to add or change test methodologies or components. Methodologies and fees are subject to change without prior notification. We will make every effort to inform clients of any test modifications, particularly with respect to reference range changes. Client Responsibility Integrity, caring, excellence and safety are the values shared by each Clinical Laboratory Partners employee. As your laboratory of choice, we share in the service commitments to each provider and patient. As Health Care Reform is enacted, we will work together to ensure full compliance to changing regulatory requirements and guidelines. To be successful in this endeavor, the acknowledgement of shared responsibility and commitment is important. We welcome the opportunity to collaborate. Client Services Hours of Coverage: 24 hours a day/7 days a week including Holidays Our Client Services Department is staffed by knowledgeable and experienced representatives dedicated to providing you with responsive personal service. Our Client Services Representatives are available to address inquiries regarding test information, patient results, specimen collection and transport. In the event you require detailed technical information, we will gladly connect you with a member of our technical staff. Clinical Laboratory Partners Page A-1

4 Compliance Policies Clinical Laboratory Partners is committed to compliance with all applicable State and Federal guidelines for clinical laboratories. This includes the Clinical Laboratory Improvement Amendments1988 (CLIA), the Centers for Medicare & Medicaid Services (CMS) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy regulations as well as other regulatory agencies. Policies are administered throughout our organization to ensure compliance. It is our expectation that organizations utilizing our services have similar policies in place. Confidentiality The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is one of the most all-encompassing pieces of healthcare legislation ever passed. Clinical Laboratory Partners is committed to full compliance to this and all privacy standards that define the limits on use and disclosure of confidential patient information, as well as the rights of individuals with respect to health information. The security provisions of HIPAA apply to confidential patient information in both electronic and paper forms. We employ rigorous security safeguards to protect the integrity and confidentiality of patient healthcare information from unauthorized use or disclosure. Patient Service Center Patients may be referred to one of our patient service centers for specimen collection. A list of our Patient Service Centers and their hours of operation can be found on our website at under the I am a Patient section. Professional Courtesy 'Professional Courtesy' testing is strictly prohibited as stated in the Anti-kickback Statute 42 U.S.C.1320a-7b. Clinical Laboratory Partners cannot honor requests for this service. Quality Assurance Through Clinical Laboratory Partners quality management system, the Quality Assurance Department actively monitors quality performance indicators for the entire process of laboratory services. This includes specimen collection and analysis to reporting and billing. These indicators become the driving force behind the active quality improvement program. All indicators and activities are closely supervised by senior management. Referral Testing Clinical Laboratory Partners may refer to certain tests to other reference laboratories in accordance with appropriate state and federal guidelines. These reference laboratories are chosen based on quality, test menu, and cost to provide the best possible patient care. Clinical Laboratory Partners Page A-2

5 Repeat Determinations Clinical Laboratory Partners performs repeat determinations routinely as part of our ongoing quality assurance program. We will repeat a test when requested by the ordering physician or their designee. Please contact the Client Services Department at (800) (option 2). Safety Clinical Laboratory Partners mandates that all specimens will be handled using universal precautions. Every effort will be made to protect all healthcare workers from exposure to hepatitis and human immunodeficiency viruses (HIV). Clinical Laboratory Partners Safety Policies adhere to state and federal requirements. Sample Storage Any specimens not utilized in the initial testing are stored refrigerated for seven days. Depending on stability, some specimen types may be kept for shorter periods of time. When a test result is inconsistent with clinical findings, the requesting physician may have the assay repeated at no charge. Specimen Container Labeling Each specimen submitted to Clinical Laboratory Partners must be appropriately labeled with two patient identifiers at the time of collection. This label must include Patient Name (First and Last Name) that matches the test requisition and at least one additional identifier such as Date of Birth or Unique Identification Number. Specimen Requisition Labeling Refer to page 5. Telephone Numbers Main Phone Number: Client Services: Test Results and General Information... Option #2 Client Supplies... Option #7 Client / Facility Billing... Option #5 Courier Pickups... Option #3 Home Draw... Option #6 Operator... Option #8 Patient Billing... Option #4 Test Add-Ons After Submission of Specimen Our Client Services Department can arrange for add-on testing if sufficient specimen volume remains after the initial tests have been completed. Clinical Laboratory Partners is required by federal regulations to obtain written authorization for every test we perform. Our clients will receive a request for written confirmation for verbal test requests. The requesting physician must sign this written confirmation and return it to Client Services. Clinical Laboratory Partners Page A-3

6 Test Ambiguous An ambiguous test order is any order received by Clinical Laboratory Partners which does not provide sufficient information to clearly determine which test or tests should be performed. Clinical Laboratory Partners shall perform and bill for only those tests which are specifically ordered by an authorized provider or his/her authorized designee. When a request for a test is ambiguous such that the test code cannot be determined, Clinical Laboratory Partners must either 1) obtain sufficient clarification from the ordering provider or designee and adequately document such clarification or 2) when applicable, perform and bill for the default test code defined in the "Default Testing Table". Please contact your sales or service representative to obtain a current copy of the table. Test Cancellations Tests may be canceled without charge while the specimen is in transit. Tests may not be canceled once they have been performed and reported. An exception will be made if there is a laboratory error. Cancellation requests can be called to the Client Services Department at (800) (option 2). Test Not Found in Directory of Services Clinical Laboratory Partners is continually developing new tests and procedures. As a result, some tests may not be listed in the current, print edition of our Directory of Services. For more information on tests not found in the Directory of Services, please contact Client Services Department at (800) (option 2) or refer to our website, Upon entering the website, click on "I am a Healthcare Professional". At the bottom of this page is a link to open the latest PDF version of our Directory of Services which is updated daily. Toxicology Testing Clinical Laboratory Partners offers drug testing ordered by the appropriate healthcare provider for clinical purposes only. Verbal Requests Federal and State regulations require that verbal requests for clinical laboratory testing MUST be followed with a written verification of said request. Veterinary Specimens Clinical Laboratory Partners does not accept animal specimens for laboratory testing. Clinical Laboratory Partners Page A-4

7 Specimen Requisition Labeling Each specimen submitted to Clinical Laboratory Partners must be accompanied by an appropriately completed specimen requisition. Please see the example of required fields on the specimen requisition form. Complete the following fields as described: Patient Information 1. Provide name in the format of Last, First, Middle Initial 2. Provide street name and house or apartment number 3. Check Male or Female for gender 4. Provide the City, State, Zip 5. Provide in the format of Month, Day, Year 6. Provide the Telephone Number with Area Code Insurance Information 7. Check off whom to bill Insurance, Patient or Client/Doctor. Provide insurance information Courtesy (Carbon) Copy Information 8. Provide the name, street, city, state, zip of the person receiving the courtesy (carbon) copy Physician Signature 9. Physician ordering tests must sign the requisition ABN Information 10. Check Yes if ABN is enclosed or No if ABN is not enclosed ICD Diagnosis Codes 11. Provide the appropriate diagnosis codes Tests 12. Check the tests to be performed Comments 13. Use this space to provide any additional information Microbiology, Source Required 14. If applicable, provide the source of the specimen Microbiology, Site 15. If applicable, provide the site of the wound Clinical Laboratory Partners Page A-5

8 Clinical Laboratory Partners Page A-6

9 Clinical Laboratory Partners Page A-7

10 STAT Laboratory Tests and Services Clinical Laboratory Partners offers comprehensive, routine and STAT laboratory testing services. STAT laboratory tests and services are defined as needing immediate attention to manage medical emergencies. STAT test requests are given the highest priority by our laboratory for logistics pickup, processing, analysis, and reporting. The tests listed on the STAT Test Menu are available 24 hours a day, 7 days a week. Any tests not specifically listed will require prior approval by the Laboratory Medical Director. All STAT testing will be completed within 4 hours. Your results will be delivered to you within that 4 hour time frame. To arrange for a STAT pick up please call 877-CLP-STAT ( ) Option 3 All additional questions should be directed to our Client Services Department at Clinical Laboratory Partners Page B-1

11 Clinical Laboratory Partners Page B-2

12 Allergy Testing Allergen Testing Performed by ImmunoCap technology (Phadia, Pharmacia Diagnostics). Allergens may be ordered individually. Specimen Requirements 1 ml serum for 1-4 allergens tested, and at least 2 ml serum for 5-10 allergens tested. Allergen Interpretation Specific Allergen IgE IgE Class ku/l Antibody Level 0 < 0.35 Absent/Undetectable Low Level Moderate Level High Level Very High Level Very High Level 6 > 100 Very High Level Table 1: Animal Allergens Animal Phadia Code Test Code Canary bird feathers e Cat epithelia e Chicken feathers e Cow dander e Dog dander e Dog epithelia e Duck feathers e Ferret epithelium e Finch feathers e Goat epithelia e Goose feathers e Guinea pig epithelia e Hamster epithelia e Horse dander e Mouse epithelia e Mouse serum proteins e Mouse urine proteins e Parrot/Parakeet droppings e Parrot/Parakeet feathers e Parrot/Parakeet serum proteins e Pigeon droppings e Pigeon feathers e Rabbit epithelia e Rat epithelia e Rat serum proteins e Rat urine proteins e Sheep epithelia e Swine epithelia e Clinical Laboratory Partners Page C-1

13 Table 2: Biologics and Occupational Allergens Biologics and Occupational Phadia Code Test Code Castor bean k Cotton sead k Ethylene oxide k Green coffee bean k Insulin bovine c Insulin porcine c Isocyanate TDI k Isocyanate MDI k Isocyanate HDI k Ispahula (Psyllium) k Latex k Penicillin G c Penicillin V c Phthalic anhydride k Silk k Sunflower seed k Wild silk k Table 3: Food Allergens Food Phadia Code Test Code Almond f Alpha-lactalbumin f Apple f Apricot f Avocado f Banana f Barley f Basil f Beef f Beta-lactoglobulin f Black pepper f Blue mussel f Blueberry f Brazil nut f Broccoli f Buckwheat f Cabbage f Carrot f Casein f Cashew nut f Cauliflower f Celery f Cheddar cheese f Cheese mold type f Cherry f Chestnut f Chicken meat f Chili pepper f Cinnamon f Clam f Cocoa f Coconut f Codfish f Coffee f Corn (Maize) f Crab Clinical Laboratory Partners f Page C-2

14 Table 3: Food Allergens (con't) Food Phadia Code Test Code Cucumber f Dill f Egg mix f Egg white f Egg yolk f Eggplant f Flounder sas Garlic f Ginger f Gluten f Goat milk f Grape f Grapefruit f Green bean f Green pepper f Halibut f Hazel nut f Honey f Kiwi fruit f Lamb f Lemon f Lentils f Lettuce f Lime f Lobster f Macadamia nut f Mackerel f Malt f Mango fruit f Melons f Milk f Mushroom f Mustard f Oat f Onion f Orange f Oregano f Oyster f Paprika f Parsley f Pea f Peach f Peanut f Pear f Pecan nut f Pine nut f Pineapple f Pistachio f Plum f Pork f Potato f Rape seed f Raspberry Red kidney bean f Rice f Clinical Laboratory Partners Page C-3

15 Table 3: Food Allergens (con't) Food Phadia Code Test Code Rye f Salmon f Scallop f Sesame seed f Shrimp f Soybean f Spinach f Squid f Strawberry f Swordfish f Tea f Tomato f Tragacanth f Trout f Tuna f Turkey meat f Vanilla f Walnut f Wheat f Whey f White bean f Yeast f Table 4: Grass Allergens Grass Phadia Code Test Code Bahia grass g Bermuda grass g Brome grass g Canary grass g Common reed g Cultivated oat pollen g Cultivated rye grass g Cultivated wheat pollen g Johnson grass g June grass g Meadow fescue g Meadow foxtail g Orchard grass (cocksfoot) g Perennial rye grass g Red top grass g Sweet vernal grass g Timothy grass g Velvet grass g Wild rye g Table 5: House Dust Allergens House Dust Phadia Code Test Code House dust (Greer) h House dust (Hollister-Stier) h Clinical Laboratory Partners Page C-4

16 Table 6: House Dust and Storage Mite Allergens House Dust and Storage Mite Phadia Code Test Code Ascarus siro d Dermatophagoides farinae d Dermatophagoides pteronyssinus d Glycyphagus domesticus (Storage mite) d Lepidoglyphus destructor (Storage mite) d Table 7: Insect and Venom Allergens Insect and Venom Phadia Code Test Code Cockroach i Fire ant i Honey bee i Mosquito i Paper wasp i White-faced hornet i Yellow hornet i Yellow jacket i Table 8: Mold Allergens Mold Phadia Code Test Code Alternaria alternata m Aspergillus fumigatus m Aspergillus niger m Aureobasidium pullulans m Botryis cinerea m Candida albicans m Cephalosporium acremonium m Cladosporium herbarum m Curvularia lunata m Epicoccum purpurascens m Fusarium moniliforme m Helminthosporium halodes m Mucor racemosus m Penicillium notatum m Phoma betae m Rhizopus nigricans m Stemphylium botryosum m Trichoderma viride m Trichophyton rubrum m Table 9: Tree Allergens Tree Phadia Code Test Code Acacia t Alder t Australian pine t Beech t Birch t Cottonwood t Elm t Eucalyptus t Hazel nut t Japanese cedar t Maple t Melaleuca t Mesquite t Clinical Laboratory Partners Page C-5

17 Table 9: Tree Allergens (con't) Tree Phadia Code Test Code Mountain cedar t Oak white t Olive t Pecan/Hickory t Privet t Queen palm t Spruce t Sweet gum t Sycamore t Walnut t White ash t White mulberry t White pine t Willow t Table 10: Weed Allergens Weed Phadia Code Test Code Cocklebur w Common ragweed (short) w Dandelion w English plantain w False ragweed w Firebush w Giant ragweed (tall) w Goldenrod w Lamb's quarters (Goose foot) w Mugwort w Nettle w Oxeye daisy w Rough marsh elder w Rough pigweed w Russian thistle w Scale w Sheep sorel w Western ragweed w Wormwood w Table 11: Other Allergens Other Phadia Code Test Code Ascaris p Echinococcus p Table 12: Animal Allergy Panel Allergen Phadia Code Panel Code Cat epithelia e Cow dander e4 Dog dander e5 Horse dander e3 Clinical Laboratory Partners Page C-6

18 Table 13: Childhood Food & Environment Panel Allergen Phadia Code Panel Code Alternaria alternata m Cat epithelia e1 Cockroach i6 Codfish f3 Dermatophagoides farinae d2 Dog dander e5 Egg white f1 Milk f2 Peanut f13 Soybean f14 Wheat f4 IgE Table 14: Children's Food Screen Allergy Panel Allergen Phadia Code Panel Code Egg white f Milk f2 Peanut f13 Soybean f14 Wheat f4 Codfish f3 Table 15: Dust Allergy Panel Allergen Phadia Code Panel Code Cockroach i Dermatophagoides farinae d2 Dermatophagoides pteronyssinus d1 House dust (Greer) h1 Table 16: Food Adult Allergy Panel Allergen Phadia Code Panel Code Clam f Codfish f338 Corn/Maize f8 Egg white f1 Milk f2 Peanut f13 Scallop f338 Shrimp f24 Soybean f14 Walnut f256 Wheat f4 Clinical Laboratory Partners Page C-7

19 Table 17: Fruit Allergy Panel Allergen Phadia Code Panel Code Apple f Apricot f237 Banana f92 Cherry f242 Grape f259 Mango f91 Melon f87 Orange f33 Peach f95 Pear f94 Pineapple f210 Raspberry Strawberry f44 IgE Table 18: General Screen Allergy Panel Allergen Phadia Code Panel Code Alternaria alternata m Aspergillus fumigatus m3 Bahia grass g17 Bermuda grass g2 Birch t3 Cat dander e1 Cladosporium herbarum m2 Cockroach i6 Common ragweed (short) w1 Dermatophagoides farinae d2 Dermatophagoides pteronyssinus d1 Dog epithelia e2 Elm t8 English plantain w9 House dust (Hollistier-Stier) h2 Lamb's quarters (Goose Foot) w10 Maple (Box elder) t1 Penicillum notatum m1 Timothy grass g6 White oak t7 IgE Clinical Laboratory Partners Page C-8

20 Table 19: Grass Allergy Panel Allergen Phadia Code Panel Code June grass g Orchard grass (cocksfoot) g3 Perennial rye grass g5 Timothy grass g6 IgE Table 20: Insect Venom Allergy Panel Allergen Phadia Code Panel Code Fire ant i Honey bee i1 Paper wasp i4 White-faced hornet i2 Yellow jacket i3 Table 21: Mold Allergy Panel Allergen Phadia Code Panel Code Alternaria alternata m Aspergillus fumigatus m3 Cladosporium herbarum m2 Mucor racemosus m4 Penicillium notatum m1 IgE Clinical Laboratory Partners Page C-9

21 Table 22: New England Regional Allergy Panel Allergen Phadia Code Panel Code Alternaria alternata m Aspergillus fumigatus m3 Beech t5 Bermuda grass g2 Birch t3 Candida albicans m5 Cladosporium herbarum m2 Common ragweed (short) w1 Cultivated rye grass g12 Dermatophagoides farinae d2 Dermatophagoides pteronyssinus d1 Dandelion w8 English plantain w9 Goldenrod w12 House dust (Greer) h1 June (Kentucky blue) grass g8 Lamb's quarters (Goose Foot) w10 Maple (Box elder) t1 Mucor racemosus m4 Mugwort w6 Oak white t7 Penicillium notatum m1 Perennial rye grass g5 Sweet vernal grass g1 Timothy grass g6 Walnut t10 White pine t16 Willow t12 Table 23: Nut Allergy Panel Allergen Phadia Code Panel Code Almond f Australian pine tree t73 Brazil nut f18 Cashew nut f202 Hazel nut tree t4 Hickory/Pecan tree t22 Macadamia nut f345 Peanut f13 Pistachio nut f203 Walnut tree t10 IgE Clinical Laboratory Partners Page C-10

22 Table 24: Respiratory Region 1 Allergy Panel Allergen Phadia Code Panel Code Alternaria alternata m Aspergillus fumigatus m3 Bermuda grass g2 Birch t3 Cat dander e1 Cladosporium herbarum m2 Cockroach i6 Common ragweed (short) w1 Cottonwood t14 Dermatophagoides farinae d2 Dermatophagoides pteronyssinus d1 Dog dander e5 Elm t8 Lamb's quarters (Goose Foot) w10 Maple (Box elder) t1 Mountain cedar (Juniper) t6 Mugwort w6 Oak white t7 Orchard grass (Cocksfoot) g3 Penicillium chrysogenum m1 Rough pigweed w14 Sheep sorrel w18 Sycamore t11 Timothy grass g6 Walnut tree t10 White ash t15 White mulberry t70 IgE Table 25: Seafood Screen Allergy Panel Allergen Phadia Code Panel Code Blue mussel f Codfish f37 Salmon f41 Shrimp f24 Tuna f40 Clinical Laboratory Partners Page C-11

23 Cytopathology Services Background Information The Cytopathology Division at Clinical Laboratory Partners originated from the oldest cytology facility and school in the state of Connecticut and its founder trained directly under Dr. George Papanicolaou. The screening staff is comprised of highly skilled ASCP certified cytotechnologists. Staff cytopathologists have been trained at some of the most prestigious training programs in the country including John Hopkins, Memorial Sloan Kettering Cancer Institute, and M.D. Anderson Cancer Center. A cytopathologist is available at all times for consultations, case reviews and correlations between pap smears and biopsies. We currently offer Pap screening on conventional, ThinPrep and SurePath specimens, as well as out-of-vial testing on liquid based specimens for high risk Human Papilloma Virus (HPV), Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (Chlamydia): Conventional Pap Test Order Code Test 8001 Pap Smear Conventional ThinPrep Pap Test Order Code (with Imager) Order Code (Manual) Test 8002 ThinPrep Pap Test ThinPrep Pap Test with HPV Screen ThinPrep Pap Test with HPV Reflex ThinPrep Pap Test with GC/Chlamydia ThinPrep Pap Test w/ HPV Screen, GC/Chlamydia ThinPrep Pap Test w/ HPV Reflex, GC/Chlamydia ThinPrep Pap HPV Scr Rfx HPV 16,18/ ThinPrep Pap Rfx HPV Rfx HPV 16,18/ ThinPrep Pap GC/CT HPV Scr Rfx HPV 16,18/ ThinPrep Pap GC/CT Rfx HPV Rfx HPV 16,18/ SurePath Pap Test Order Code (with FocalPoint) Order Code (Manual) Test 8020 SurePath Pap Test SurePath Pap Test with HPV Screen SurePath Pap Test with HPV Reflex SurePath Pap Test with GC/Chlamydia SurePath Pap Test w/ HPV Screen, GC/Chlamydia SurePath Pap Test w/ HPV Reflex, GC/Chlamydia 8122 Clinical Laboratory Partners Page D-1

24 Collection of Gyn Cytology Specimens Collection should be performed according to conventional or liquid based Pap (LBP) test specification and accepted practice among clinicians. Ideally, all gynecological specimens should be collected mid-cycle if the patient is pre-menopausal or is receiving hormonal replacement therapy. In addition, the patient should not douche, use vaginal creams or have intercourse for 24 hours before the test is performed. The sample should be taken before the bimanual examination and before other tests (i.e., for GC and Chlamydia) Pap Smear Handling Requirements Note: Physician must sign all test requisitions. 1. Complete a cytology requisition with the patient s name, age and last menstrual period (LMP), test order, pertinent clinical history (including previous abnormal cytology), physical findings, and the source of the specimen. 2. Check the box associated with the test requested: Routine or Abnormal Follow Up and/or for liquid based tests (HPV screen, Reflex HPV, Digene Swab HPV or Chlamydia/N. gonorrhoeae). Include ICD9 Code. 3. For liquid based samples each specimen submitted to Clinical Laboratory Partners must be appropriately labeled with two patient identifiers at the time of collection. This label must include Patient Name (First and Last Name) that matches the test requisition and at least one additional identifier such as Date of Birth or Unique Identification Number. Vials that are not labeled properly will be rejected for processing, the physician will be notified and the specimen processed after receiving the proper information/confirmation. The vial lid should be tightened to prevent leakage in transit. Submit with requisition in a specimen bag. 4. For conventional, glass-slide based, smears, pencil the patient s name and source of the specimen onto the end of a clean slide or slides. Slides that are not labeled properly will be rejected for processing, the physician will be notified and the specimen processed after receiving the proper information/confirmation. Immediately after collection, spray-fix the specimen and place slide(s) in a clean, cardboard folder and secure. Submit with requisition in a plastic specimen bag. Clinical Laboratory Partners Page D-2

25 Bethesda System for Reporting Pap Smears The Bethesda System for GYN Cytology smear reporting is the standard format in our laboratory and throughout the United States. The following are the basic elements of a report under this system: 1. An Adequacy Statement - "Satisfactory," or "Unsatisfactory" 2. An explanation will accompany any interpretation noted as "Unsatisfactory." 3. The Cytologic Diagnosis: a. Negative for Intraepithelial Lesion or Malignancy b. The specific cytologic entity identified including: i. Infectious agents and reactive cellular changes. ii. Cellular abnormalities of undetermined significance. iii. Squamous Intraepithelial Lesions (precursors of squamous carcinoma). iv. Glandular abnormalities (precursors of adenocarcinoma). v. Cellular features of malignancy, with the type of tumor specified if possible. vi. Recommendation for follow-up of the abnormalities detected. vii. Any limiting factors such as obscuring inflammation, blood, foreign material etc. Rejection System Interpretation Cytology specimens will be rejected for testing if any of the following conditions occur: Fixed slides are received broken into small pieces. o (Every effort will be made to process the slide if it is broken into a few large pieces.) Specimen and/or requisition do not contain adequate patient identification. Mismatched last or first name on vial/requisition. No name and unique identifier on requisition or specimen. o These specimens and requisitions will be returned to the physician for resolution. In addition to rejection of the above types of specimens, a result of "Unsatisfactory" will be reported for the following reasons: No cellular material Too few cells for adequate evaluation (< 25% slide contains cells) Poor fixation and/or preservation Epithelial cells obscured by blood and/or inflammation (75% of epithelial material obscured) Cells obscured by foreign material (e.g. lubricant) (< 25 % slide visible) Excessive cytolysis/autolysis Specimen too thick for evaluation (< 25% smear visible) Insufficient squamous material (smears consist primarily of endocervical cells) No specimen received Cells obscured by bacteria Clinical Laboratory Partners Page D-3

26 Conventional Method: This method has been surpassed by liquid based Pap (LBP) tests and is no longer recommended. Cervix: Rotate spatula with good pressure over entire ectocervix Endocervix: Recommend endocervical brush; rotate ¼ to ½ turn. Spread material thinly, but rapidly, on labeled glass slide(s) and fix immediately (<10 seconds) either by immersion (95% alcohol) or with a commercial spray fixative (held at least 10 inches from slide to prevent cellular distortion). Rapid fixation is crucial to providing an adequate specimen for proper evaluation of the Pap smear. ThinPrep Collection Method: NOTE: When submitting samples using the ThinPrep Same technique, be sure to swirl the plastic spatula in the vial of PreservCyt Solution and recap the vial until collection from the endocervix. Then, rinse the Cytobrush in the same vial by rotating the device in the solution 10 times while pushing it against the wall of the vial. Swirl the device vigorously to further release the material. Discard both spatula and brush. Tighten the vial cap so that the torque line on the cap passes the torque line on the vial. Brush/Spatula Protocol 1. Obtain an adequate sampling from the ectocervix using a plastic spatula. 2. Rinse the spatula as quickly as possible into the PreservCyt solution vial by swirling the spatula vigorously in the vial 10 times. Discard the spatula. 3. Obtain an adequate sampling from the endocervix using an endocervical brush device. a. Insert the brush into the cervix until only the bottommost fibers are exposed. Slowly rotate ¼ or ½ turn in one direction. DO NOT OVER-ROTATE. 4. Rinse the brush as quickly as possible 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. Discard the brush. 5. Tighten the cap so that the torque line on the cap passes the torque line on the vial. 6. Record the patients name and ID number on the vial. The patient information and medical history on the cytology requisition form. 7. Place the vial and requisition in a specimen bag for transport to the laboratory. Clinical Laboratory Partners Page D-4

27 SurePath Collection Method: 1: Collect Collect the cytology sample using either a broom-like device or combination brush/spatula with detachable heads. 2: Drop Drop the detachable head into the SurePath vial 3: Tighten Place the cap on the vial and tighten. 4: Record The patients name and ID number on the vial. The patient information and medical history on the cytology requisition form. 5: Send The SurePath vial to the lab for processing. Particularly in older women, some method of detecting endometrial disease, such as a vaginal pool specimen or cervical canal aspiration, should be included. Non-Gyn Cytology Specimens Cytology specimens submitted to Clinical Laboratory Partners must be appropriately labeled with two patient identifiers at the time of collection. This label must include Patient Name (First and Last Name) that matches the test requisition and has at least one additional identifier such as Date of Birth or Unique Identification Number. If a syringe is used as a transport vehicle, the needle should be removed before submitting the specimen to the laboratory. If prepared slides are submitted, the patient s name should be written in pencil on the frosted end. For testing other than cytologic evaluation, separate samples should be sent to the appropriate laboratory along with the proper requisition form. A completed cytology requisition should accompany each specimen and include patient demographics and pertinent clinical information. Specimens not submitted promptly should be kept refrigerated to prevent cellular degeneration. Instructions For Collection 1. The sputum specimens may be submitted unfixed in sputum specimen cups or may be placed in 30 cc of Cytolyte. 2. Endoscopic specimens (bronchial & GI tract) may be submitted in several ways: a. The operator may smear material on frosted slides and then either spray fix or immerse the slides in 95% ethanol. A paper clip should be used to keep the slides from sticking together. It is essential that prepared slides have the patient s name written on them in pencil since ink will dissolve during processing. b. The tip of the brush used for sampling may be submitted in Cytolyte and slides will be prepared in the laboratory. c. Mucosal washings may be submitted in specimen s or in Cytolyte solution. Clinical Laboratory Partners Page D-5

28 3. Urine specimens should be designated as "voided" or, if obtained by instrumentation of the urinary tract, as "catheterized." If a patient has received BCG or intravesical chemotherapy, that information should be included along with the date of the most recent treatment. Fresh urine samples (do not send the first void of the day) should be sent in sterile urine cups. If more than a few hours delay in specimen submission is anticipated, 30 cc of Cytolyte should be added to preserve the sample. 4. Body cavity fluids (peritoneal, pleural, and pericardial) should not be submitted in lavender top (EDTA containing) s since those samples frequently clot which interferes with cytological evaluation. A minimum of 10 cc is recommended. If additional fluid is available, 50cc should also be sent unfixed to Surgical Pathology for a cell block since the yield of malignant diagnoses is increased with examination of both types of specimens. 5. Spinal fluid for cytology should be sent in the plastic s provided with the lumbar puncture kits. If other tests are required, separate s should be submitted to the appropriate laboratory. If leukemia or lymphoma is suspected, a specimen should be sent directly to the Hematology Laboratory. 6. Fine needle aspiration biopsies should be spread on frosted slides and fixed in 95% ethanol immediately. Even a few seconds of air-drying can make a specimen un-interpretable. It is essential that prepared slides have the patient s name written on them in pencil since ink will dissolve during processing. If small tissue fragments are retrieved, they should be submitted in formalin to Surgical Pathology along with a completed Pathology requisition. If a lymphoid neoplasm is suspected, contact the laboratory in advance so that arrangements can be made to process material for marker studies or flow cytometry. A variety of special studies including electron microscopy and cytogenetics can be performed on FNA specimens if the laboratory is notified in advance. 7. If you have any questions regarding collection technique or have questions regarding a specific biopsy to be performed, please contact our Client Services Department at Option #2. Clinical Laboratory Partners Page D-6

29 Microbiology Transport Media Please send microbiology specimens in the appropriate sterile container or transport device as displayed on the following pages. All specimens must be labeled with patient s name, date of birth, time and date of collection. The label on the specimens must match the information given on the requisition. Submit all specimens at the appropriate transport temperature to ensure organism viability. If you have any questions please call Client Services at (option 2). Clinical Laboratory Partners Page E-1

30

31

32

33 Collection Instructions for Microbiology Specimens Purpose Specimens for microbiology analysis are likely to contain living organisms whose recognition depends on rapid and proper specimen management. Appropriate selection, collection and transport of specimens is essential to allow for the detection of diverse microbial pathogens. General Considerations Use the Microbiology Transport Media Guide for each test in the following tables. Use aseptic techniques when collecting specimens. Contamination from normal flora will lead to specimen rejection or may not be a true representation of the infected site. Collect an adequate amount of specimen. Inadequate sample may lead to false negative results. Identify the source or site as specifically as possible. Transport specimen to the laboratory promptly after collection at the specified temperature. Collection Instructions are Listed for the Following Specimens: Blood Cultures Body Fluid Cultures Bone Marrow Cultures Cutaneous Specimens for Fungal Cultures Ear Cultures Eye Cultures Gastrointestinal Specimens Genital Specimens Lung Aspirate Specimens Lung Tissue/Biopsy Specimens Respiratory Specimens Tissue Specimens Urine Specimens Vesicle Specimens Wound specimens Blood Cultures A total of 3 blood cultures collected within a 24 hour period are optimal for the detection of septicemia. It is important to allow the vacuum to completely fill the bottles to avoid false negative results. SPS s or routine blood culture bottles (Bactec Plus + Aerobic/F and Bactec Lytic/10 Anaerobic F) are suboptimal for the detection of Mycobacteria, Bartonella, and fungi. Bactec Myco F/Lytic bottles are the method of choice for Mycobacteria and fungi. Bartonella blood cultures should be collected in a lavender top EDTA. Blood cultures should be collected before antimicrobial therapy is initiated. All blood cultures should be collected before inoculating other vacutainer s. Clinical Laboratory Partners Page F-1

34 Bacteria 1. Swab the Bactec Plus + Aerobic/F and Bactec Lytic/10 Anaerobic F bottle caps with 70% alcohol and allow them to dry. 2. Tie the tourniquet and select the venipuncture site. Using 70% alcohol, disinfect the skin by making concentric circles in an outward direction from the intended site to about 5 centimeters. Allow to dry for 1 minute. 3. Next, use a Chlora Prep One Step applicator to disinfect the skin by making concentric circles in an outward direction from the center of the intended site to about 5 centimeters. Allow the site to dry for 1 minute. (Iodine should be used for pediatric patients under 2 years of age.) 4. If site must be re-palpated before performing venipuncture, the gloved finger must be disinfected in the same manner. 5. Do not allow the needle to come in contact with any other object prior to inoculation. 6. Allow the Bactec bottles to fill completely (8-10 ml of blood). If using a syringe, do not force blood into the bottles, but allow the vacuum to fill the bottle. 7. Mix the bottles by gently rotating 5-10 times. Do not invert bottles. 8. Record the date and time of collection on the requisition. 9. Remove the iodine from the patient s skin using an alcohol prep (some patients are sensitive to iodine). 10. Transport bottles to the laboratory at room temperature. Fungi, Mycobacteria (AFB) 1. Swab the Bactec MycoF/Lytic bottle cap with 70% alcohol and allow it to dry. 2. Tie the tourniquet and select the venipuncture site. Using 70% alcohol, disinfect the skin by making concentric circles in an outward direction from the intended site to about 5 centimeters. Allow to dry for 1 minute. 3. Next, use a Chlora Prep One Step applicator to disinfect the skin by making concentric circles in an outward direction from the center of the intended site to about 5 centimeters. Allow the site to dry for 1 minute. (Iodine should be used for pediatric patients under 2 years of age.) 4. If site must be re-palpated before performing venipuncture, the gloved finger must be disinfected in the same manner. 5. Do not allow the needle to come in contact with any other object prior to inoculation. 6. Allow the Bactec MycoF/Lytic bottle to fill completely (8-10 ml of blood). 7. Mix the by gently inverting 5-10 times. 8. Initial the requisition and record the date and time of collection on the requisition. 9. Remove the iodine from the patient s skin using an alcohol prep. 10. Transport bottles to the laboratory at room temperature. Clinical Laboratory Partners Page F-2

35 Parasites Plasmodium, Babesia, Trypanosoma, Anaplasma (Ehrlichia) 1. Select the venipuncture site. 2. Disinfect the site with 70% alcohol. 3. Collect 5 ml of blood into a lavender top EDTA. 4. Label appropriately. 5. Transport to the laboratory at room temperature immediately. Viruses CMV Early Antigen Shell Vial Culture 1. Select the venipuncture site. 2. Disinfect the site with 70% alcohol. 3. Collect 2 full green top sodium heparin or lithium heparin s. 4. Label the s appropriately. 5. Transport to the laboratory immediately on ice or refrigerated Body Fluid and CSF Cultures Bacteria, Fungi, Mycobacteria (AFB) Body Fluid: 1. Collect fluid aseptically in a sterile container or yellow top SPS and transport to the laboratory at room temperature. CSF: 1. Disinfect site with 2% iodine tincture. 2. Insert a needle with stylet at L3-L4, L4-L5 or L5-S1 interspace. 3. On reaching the subarachnoid space, remove the stylet and collect 1-2 ml of fluid in each of three leakproof s. 4. Submit the second to microbiology. If only one is collected, it should be submitted to microbiology first prior to performing other testing. 5. Transport at room temperature. Viruses Body Fluid: 1. Collect fluid aseptically in a sterile container, yellow top SPS or pink liquid viral transport media. 2. SPS and sterile container must be transported immediately to the laboratory on ice or refrigerated. CSF: 1. Disinfect site with 2% iodine tincture. 2. Insert a needle with stylet at L3-L4, L4-L5 or L5-S1 interspace. 3. On reaching the subarachnoid space, remove the stylet and collect 1-2 ml of fluid in each of three leakproof s. 4. Submit the second to microbiology. If only one is collected, it should be submitted to microbiology first, prior to performing other testing. 5. Transport, on ice or refrigerated immediately to the laboratory Clinical Laboratory Partners Page F-3

36 Bone Marrow Cultures Bacteria, Fungi, Mycobacteria (AFB), Viruses 1. Prepare site as for surgical incision. 2. Aspirate approximately 3-5 ml of bone marrow and place in a yellow top SPS. 3. For viruses, transport on ice or refrigerated immediately to the laboratory Ear Cultures Bacteria, Fungi External ear: Cultures of the external ear are of limited value since normal skin flora is found in this area. In order to obtain an adequate, significant culture there should be a visible purulent drainage. Middle ear: Cultures of the middle ear cannot be collected using a sterile transport swab. The physician must collect an aspirate from the middle ear using a syringe. The fluid should be inoculated into a yellow top SPS for transport to the laboratory. Swab specimen collection: 1. Thoroughly clean external ear with a sterile swab and saline. 2. Open transport swab pack and remove sterile swab. (The transport swab consists of a rayon swab on a plastic shaft secured to a cap. The swab contained with the cap is then inserted into a plastic transport containing Amies medium without charcoal following specimen collection. Amies medium supports the growth of both anaerobic and aerobic organisms). 3. Collect new drainage as it appears onto the swab. 4. Remove the transport of medium from package and remove cap. 5. Place swab into the medium and push the swab cap firmly onto the. 6. Label and transport to the laboratory at room temperature Eye Cultures Bacteria, Fungi Eye cultures are actually cultures of the conjunctiva. If both eyes are cultured, a separate specimen should be collected from each eye (label as left or right). 1. Using an orange cap mini-tip culture transport swab, collect conjunctival specimen. 2. Place the swab into the transport medium. 3. Label and transport immediately to the laboratory at room temperature. Viruses, Chlamydia trachomatis 1. Using the mini-tip swab, collect conjunctival specimen. 2. Remove cap from transport and place the swab into pink liquid transport media. 3. Label and transport to the laboratory at room temperature immediately Clinical Laboratory Partners Page F-4

37 Genital Specimens Affirm (Vaginitis DNA Probe) For vaginal specimen collection, use only the Affirm VPIII Ambient Temperature Transport system. Separate swabs must be used for other tests, e.g. culture or microscopic slide samples. 1. Tear open the Affirm kit and label the Sample Collection Tube (SCT) with the patient identification information, include the time the sample was collected. 2. Remove the dropper and break the ampule. 3. Remove the cap from the sample collection and dispense dropper contents into. 4. Place the patient in position for a pelvic examination, insert an Unlubricated speculum (without jelly or water) into the vagina to permit visualization of the posterior vaginal fornix. 5. Using the sterile swab, obtain a sample from the posterior vaginal fornix. Twist or roll the swab against the vaginal wall two or three times, ensuring the entire circumference of the swab has touched the vaginal wall. Swab the lateral vaginal wall. Swab the lateral vaginal wall while removing the swab. 6. Immediately place the swab into the Sample Collection Tube (SCT). 7. With the swab touching the BOTTOM of the collection, grasp the prescored handle of the swab just above the top of the and bend until the swab breaks. When the swab is fully inserted into the collection, the score mark on the swab is approximately 1 cm above the top of the collection. Discard the broken handle into an infectious waste container. 8. Place the cap over the exposed end of the swab and firmly press the cap onto the. The cap will 'snap' onto the when it is properly seated. 9. Transport to the laboratory at room temperature. Bacteria, Fungi, Trichomonas (For culture or Trichomonas wet prep) Vaginal/Cervical Swab 1. Moisten speculum with warm water; lubricants may be toxic to organisms. 2. Collect secretions from the mucosa high in the vaginal canal using a blue cap bacterial transport swab. 3. For cervical/endocervical specimens, visualize cervix and remove any mucous or vaginal material from the cervical os. 4. Gently compress the cervix with the blades of the speculum and collect the endocervical discharge with a blue cap bacterial transport swab. 5. Alternatively, insert the swab into the cervical os, allow it to remain in place for a few seconds, and then remove it. 6. Place swab in transport media and transport to the laboratory at room temperature. Vaginal/Rectal (for Group B Strep) 1. Swab the vaginal introitus and then the anorectum using one blue cap transport swab. 2. Cervical swabs are not acceptable and a speculum should not be used. 3. Place swab in transport media and transport to the laboratory at room temperature Clinical Laboratory Partners Page F-5

38 Urethral/penile 1. Place swab in transport media and transport to the laboratory. Collect specimen at least 2 hours after the patient has urinated. 2. Remove the external skin flora of the urethral meatus using sterile towelettes or soap and water. 3. Rinse with wet gauze pads. 4. Insert an orange cap flexible wire mini-tip urethrogenital swab 2-4 cm into the endourethra, gently rotate it, leave it in place for 1-2 seconds, and then withdraw it. 5. Alternatively, express exudate from the urethra and collect in on a swab. 6. Place swab in transport media and transport to the laboratory at room temperature. GC/Chlamydia by DNA (female genital) 1. Using the APTIMA cleaning swab (white shaft swab in the package with red printing), remove excess mucus from the cervical os and surrounding mucosa. Discard this swab. If excess mucus is present in the cervical os, remove with a large-tipped cleaning swab (not provided) then discard the swab. 2. Insert the specimen collection swab (blue shaft swab in the package with green printing) into the endocervical canal. 3. Gently rotate the swab clockwise for seconds in the endocervical canal to ensure adequate sampling. 4. Place swab in APTIMA transport. 5. Transport to the laboratory at room temperature. GC/Chlamydia by DNA (male genital) 1. Collect specimen at least 2 hours after the patient has urinated. 2. Insert the specimen collection swab (blue shaft swab in the package with green printing) into the urethra, gently rotate it, leave it in place for 1-2 seconds, and then withdraw it. 3. Place swab in APTIMA transport. 4. Transport to the laboratory at room temperature. Viruses (Herpes simplex) 1. Collect specimen from vaginal/cervical/urethral area as described above using blue cap or orange cap min-tip swab. 2. Place swab in pink liquid viral transport media and transport to the laboratory at room temperature. Chlamydia trachomatis culture 1. Collect specimen from cervical/urethral area as described above using blue cap or orange cap min-tip swab. 2. Place swab in pink liquid viral transport media and transport to the laboratory at room temperature Clinical Laboratory Partners Page F-6