AmeriPath Cleveland

A m e r i P a t h C l e v e l a n d

7 7 3 0 F i r s t P l a c e

S u i t e A

O a k w o o d V i l l a g e , O H 4 4 1 4 6

4 4 0 - 7 0 3 - 2 1 0 0

4 4 0 - 7 0 3 - 2 1 5 5

Specimen Collection Manual

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Laboratory Reviews

Medical Director Approvals

Print Name and Title Signature Date

Review

Print Name and Title Signature Date

Version Issue Date Reviser (immediate retired and prior three years)

1.0 2013 BD Initial roll out

2.0 4/30/15 BD- Product Limitations and course of action + updated contacts

3.0 8/18/16 BD- Updated contacts

4.0 6/7/17 BD- Updated Contracts

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TABLE OF CONTENTS

General Information Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Laboratory Staff . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Phone Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Laboratory Accreditation . . . . . . . . . . . . . . . . . . 5 Test Methodologies . . . . . . . . . . . . . . . . . . . . . . . 5 Results and Reports . . . . . . . . . . . . . . . . . . . . . . . 5 Special Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Manual Distribution . . . . . . . . . . . . . . . . . . . . . . . 5 Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Specimens for Histology (Tissue) Examination

General Information . . . . . . . . . . . . . . . . . . . . . . . 7 Primary Specimen Container . . . . . . 7 Completion of Requisition . . . . . . . . . 7 Packaging the Specimen. . . . . . . . . . 8 Specimen orientation . . . . . . . . . . . . . . . . 9 Specimens with other Requirements . . . . 9 Stone analysis . . . . . . . . . . . . . . . . . . . . . 9 Specimen Rejection Policy . . . . . . . . . . . 9 Verbal Orders . . . . . . . . . . . . . . . . . . . . . 9

Courier Services . . . . . . . . . . . . . . . . . . . 10 Ordering Supplies . . . . . . . . . . . . . . . . . . 10

Specimens for Non-Gynecological Cytology Examination General information

Requisition . . . . . . . . . . . . . . . . . . . . . . . 11 Packing the Specimen . . . . . . . . . . . . . . . 11

Non-Gyn Specimen submission . . . . . . . . . . . . . . 12 Specimen Collection

Body Fluids (Pleural, Peritoneal, & Pericardial)…13 Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Urine for UroVysion………………………. 13 Sputum. . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Cerebrospinal fluid . . . . . . . . . . . . . . . . . . 14 Breast (nipple secretions and cyst aspirates) 15 Fine needle aspirates . . . . . . . . . . . . . . . . . . 15

Specimen Rejection…………………………………….. 16

Non-Routine Specimen Collection Quick Reference Guide… 17

Limitations of Specimen Collection Materials……………....... 18 Supply Order Form (use for requesting lab supplies)……….. 19

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PREFACE

The purpose of this manual is:

1. To provide instructions for specimen collection and submission to the AmeriPath Cleveland laboratory for evaluation;

2. To help ensure that the specimen is submitted appropriately and complete information is provided in order to achieve accurate and timely diagnoses;

3. To help save patients the unnecessary inconvenience and costs of repeated tests.

Detailed information is provided regarding specimen requirements, specimen collection and labeling, and data

management. If you cannot find the answers to your questions in this manual, please call the laboratory.

If a client orders a test that is not performed at Ameripath Cleveland, the specimen is referred to an accredited and

licensed reference laboratory, chosen for their quality of service including, accuracy, reliability, turn-around-time, as well

as the range of services offered.

AmeriPath Cleveland strives to maintain a reputation for quality, innovation, and dependability and we welcome

comments and suggestions to further that goal.

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LABORATORY STAFF

Robert Petras, MD……...Managing Director and Director of Institute of Gastrointestinal Pathology Terry Gramlich, MD…………...…………………………Pathologist and Director of Hepatopathology William Katzin, MD, PhD…………………………………..….……Pathologist and Laboratory Director Katherine Watts, MD ………………………………………………………………...GU Staff Pathologist Megan Lockyer, DO……………………………………………………………………….Staff Pathologist

Jessica Sigel, MD ………….……………Dermatopathologist and Director of Dermpath Diagnostics

Caroline Sok, MD………………………………………………….…………………..Dermatopathologist

Becky DiLallo..…………………………………………………………..Laboratory Operations Manager

Kristen Occhionero. …………………………………………………………………..Executive Assistant

LaToiya Muse.………………………………………………………………….…….....Histology Manager

Ryan Rouser…….....……..……………………………………….…….Client Service and LIS Manager

Nancy Dice….…………………………………………………..Regional Information Systems Manager

Dan Gartland…..…..….………………………….………..………Regional AP Sales Territory Manager

Kirsten Grove………………………………………………Southern Ohio Oncology Account Executive

Kyri Espy……………………………………………………………OH/PA Oncology Account Excecutive

Rachel Groggel…………………………………………………..Ohio/PA Dermatology Account Executive

PHONE NUMBERS

Customer Service (8:30 a.m.-5:00 p.m.). . . . . . . . . . . . . . . . . . . . . . . …440-703-2100

Courier Pick-up (8:30 a.m.-5:00 p.m.) . . . . . . . . . . . . . . . . . . . . . . . . . .440-703-2100

Non-Gynecologic Cytology Collection Information: . . . . . ……………. . 440-703-2183

Histology (tissue) Collection Information . . . . . . . . . . . . . . . . . . . . . . . . 440-703-2119

Fax Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ….. ...440-703-2155

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LABORATORY ACCREDITATION

U.S. Department of Health and Human Services CLIA #36D0656067.

College of American Pathologists Laboratory Accreditation Number: 7193598

TEST METHODOLOGIES

Upon request, the laboratory will provide clients a list of current test methods, including performance specifications.

When the laboratory changes an analytic methodology, reagents, reference ranges, or anything else, which may

significantly impact patient test results or their interpretation, the change is communicated and explained through the use

of direct mailings or within the body of the test report itself.

RESULTS AND REPORTS

Results of cytology and histology evaluations are entered into the Ameripath Cleveland computer system as the tests are

completed. Printed reports are sent through the mail or delivered by our courier. Reports may also be printed directly at

the referring physician’s office and may also be obtained through a web portal.

The Client Services Department has been designed to give physicians, nurses, and office personnel, as well as hospital-

based pathologists and laboratory personnel a central location to call for report results and/or status.

Our Client Services Department is available to access specific reports and facilitate communication between our referring

physicians and the staff pathologists. Slide requests are also handled by this department.

SPECIAL TESTS

In addition to routine histopathology and cytopathology, special tests are also available, including but not limited to:

Molecular studies (e.g. Cytogenetics, PCR, and Fluorescence In Situ Hybridization, Mutation Analysis)

Flow cytometry

Immunohistology (including Estrogen/Progesterone Receptor and Her-2/Neu oncogene studies)

Direct and indirect immunofluorescence

Chemical analysis of renal calculi

DISTRIBUTION OF MANUAL

This manual is distributed to all physician offices and surgical centers utilizing Ameripath Cleveland services. A

distribution list is maintained in the client services department.

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COMPLIANCE WITH FEDERAL AND REGULATORY AGENCIES

Ameripath—Cleveland is committed to maintaining a culture which promotes prevention, detection, and resolution of instances of conduct that do not conform with:

Federal and state laws

Regulatory agency requirements

Federal, state, and private payer health care program requirements

The laboratory’s ethical and business policies As part of this commitment, physicians are notified of policies related to regulatory requirements. Ameripath Cleveland will update physicians as to changes in the medical necessity and billing compliance requirements relating to cytology and histology in order to protect both the physician and the laboratory.

TEST ORDERING AND SPECIMEN SUBMISSION Laboratory testing at Ameripath Cleveland must be ordered by a physician. All orders must be accompanied by a written requisition, including “add-on” tests. All specimens must be appropriately labeled.

MEDICAL NECESSITY AND ADVANCED BENEFICIARY NOTIFICATIONS Laboratories can submit claims to federally funded health programs only for services considered medically necessary. An ICD-9CM code should be submitted with all orders substantiating the medical necessity of the testing. For tests which do not meet the federally defined criteria for medical necessity, an advanced beneficiary notice or ABN is required. The ABN gives the patient advance notice that Medicare will not pay for the procedure. For other biopsies, medicare patients must review and sign an ABN for noncovered services.

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SPECIMENS FOR HISTOLOGY (TISSUE) EXAMINATION

GENERAL INFORMATION Our ability to provide you with the highest quality testing and service is tied directly to your diligence in the preparation of each specimen and the clarity and completeness of the information provided on each requisition. Some tests can be performed only if the specimen is handled in a specific manner. Routine handling may PRECLUDE the possibility of performing the desired test. Some examples of such special tests are:

Immunofluorescence

Cytogenetic Studies

Flow Cytometry Should you have any questions of a technical nature, please, do not hesitate to call (440) 703-2150 and ask for assistance. 1. Primary specimen container:

All specimens must be placed in a primary specimen container with the lid tightly secured to prevent leaking. The container (not the lid) must be labeled with the patient’s first and last name, the specimen source, and the name of the submitting physician. At a minimum, two patient identifiers (patient first and last name, date of birth, Social Security number, or accession number) must be included on the primary specimen container. When multiple specimens are obtained from separate sites, they should be placed in separate containers with each source clearly identified. This may be especially important when there is a possibility that further local treatment may be necessary or when the distribution of a disease process is critical for diagnosis (e.g. Crohn’s disease) or patient management.

Most biopsies are submitted in formalin, which contains formaldehyde. Use caution when handling as formaldehyde is toxic if inhaled or swallowed and it can be irritating to the respiratory system and skin. There is risk of serious injury if formaldehyde comes in contact with the eyes. Formaldehyde is a known carcinogen and repeated or prolonged exposure increases the risk. A formalin warning label must be attached to the container (most containers are pre-labeled by the factory before use). If a pre-labeled container is not used, please identify the solution containing the specimen on the specimen container (i.e. formalin, glutaraldehyde, saline, etc.). NOTE: We provide specimen containers of varying size that contain formalin. We will deliver these to you at no cost. You should consider keeping a few larger containers on hand for larger biopsy specimens. Use caution when handling a biopsy, being careful not to crush or tear the tissue and making certain that no tissue remains attached to the forceps or other instrument used to transfer the tissue. Do not allow the specimen to dry out. Place larger specimens in a larger container with enough formalin to completely immerse the specimen. The volume of formalin should exceed the volume of tissue by at least 10-fold. This will facilitate its fixation, and prevent degeneration of the tissue. Please do not force a large specimen into a small container. 2. Completion of the biopsy requisition: Please use a separate requisition form for each of the following specimen types:

Skin biopsy—Dermatopathology Requisition

Gastrointestinal biopsy—GI Institute Requisition

Prostate biopsies/Urine for UroVision testing—Urologic Pathology Requisition

Cervical, vulvar or endometrial biopsy—Gynecologic Pathology Requisition

All other biopsies—Surgical Pathology Requisition

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A completed biopsy requisition form MUST accompany each patient’s specimen(s). Only one biopsy requisition is required for each patient, even if biopsies are obtained from multiple sites. In order for us to achieve accurate and timely billing of your patients, we must recieve accurate and legibly written patient information. The completed requisition should include the following information:

Complete patient name as it appears on the primary insurance card;

Complete address of the patient;

Patient’s date of birth, age, sex, phone number, and social security number (the social security number is not required but is very useful for patient identification);

Guarantor’s name if other than the patient;

Complete insurance information (it is best to attach a copy of the front and back of the patient’s insurance card(s) to the requisition);

Appropriate ICD-9 code;

Patient’s clinical history (this is a regulatory requirement because of the importance in aiding accurate diagnosis);

Requesting physician’s first and last name (circle appropriate choice if multiple physician names appear on the requisition);

Names of physician(s) who should receive a copy of the pathology report;

Specimen type and source;

The physician’s clinical impression(s) or diagnosis for each site;

Specimen collection date; and,

Laboratory procedures or special tests that are desired.

If the information listed above is not complete and legible, processing of the specimen may be delayed while we contact your office by phone or fax to obtain the required information.

Note: The third copy of the requisition is for your office use, and may be disposed of if not needed by your office. A second copy of the requisition is for lab use and must be submitted with the specimen.

3. Packing the specimen:

Courier pick-up: Place the completed patient requisition into the outer pouch of a zip-lock bag clearly labeled bio-hazard bag (we provide these). Place the primary specimen container into the bag and zip-lock it shut to further prevent any possible leakage. The specimen(s) are now ready for Courier pick-up.

Fed-Ex shipment:

NOTE: We provide Fed-ex canisters, shipping boxes, pre-printed Fed-Ex airbills, and Fed-Ex Express Large Clinical Paks.

Place the bio-hazard bag (with the specimen and requisition) into the bio-hazard canister. Make sure the lid is closed completely. Place the canister into another bio-hazard plastic bag and ziplock the bag. The canister is then placed into a bio-hazard shipping box (the box has detailed packing instructions printed on the inside). Tape the box shut. Mark all shipping instructions on your pre-printed Fed-Ex airbills (addressed to Ameripath—Cleveland). Attach the airbill to the Fed-Ex Clinical Pak (plastic bag). Place the shipping box into the Fed-Ex Express Large Clinical Pak. Seal the pack by following the instructions on it. Your package is now ready to ship.

For the safety of all personnel involved, do not send sharps (e.g. scalpel blades, syringe needles, etc.) with the specimen, unless it has bearing on the case, such as a foreign body removed from the patient. 4. Specimens with anatomic orientation: When submitting specimens in cases when anatomic orientation is important, there are two suggested methods for marking the specimen:

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a) The preferred method is to mark the specimen with a suture or sutures. The location of the suture(s) should then

be clearly written on the requisition form. b) A cut or notch may be made in the specimen to mark its orientation. However, if the lateral edges of the

specimen are jagged, curled, or uneven it may be difficult or impossible to determine the orientation of the specimen if this method is used. Write the location of the cut or notch on the requisition form.

5. Specimens with other specific requirements

The following specimens should be received fresh and require immediate processing. Contact the laboratory at

(440) 703-2150 for instructions.

a) Diagnostic Lymph Node Biopsies – must be received fresh or in tissue tranport medium (available from Ameripath

Cleveland) in order to allow immunophenotypic analysis by flow cytometry. If overnight transport cannot be

assured, or if the biopsy is performed on a Friday, then the lymph node should be fixed in formalin. b) Products of Conception – submit a portion fresh in sterile saline if cytogenetic testing is needed; otherwise, place

entire specimen in formalin. c) Tissue biopsies for Immunofluorescence – must be received in Michel’s transport solution (available from

Ameripath Cleveland). d) Tissue for Electron Microscopy – Must be received fresh in saline or immediately placed in 2.5% glutaraldehyde

(tissue fragments must be 1 mm in diameter or smaller). Vials of 2.5% glutaraldehyde are available from Ameripath Cleveland and should be kept in a refrigerator until used.

6. Stone (Calculus) Analysis Air-dry the stone and place in a clean, dry container (such as a sterile urine container). Stones transported in liquid or bound up in tape interfere with and delay analysis, compromising results. Label as instructed, and submit with completed requisition (see sections 2 and 3 above). 7. Additional general information pertaining to histopathology specimens SPECIMEN REJECTION POLICY: It is our policy at Ameripath Cleveland to meet all regulatory agency guidelines and to provide the best patient care possible. To do so we must enforce the following procedures:

All requisitions must have the patient’s name, patient demographics (address, date of birth) tissue type, and relevant clinical history.

All specimen containers must be labeled with at a minimum, two patient identifiers (patient first and last name, date of birth, Social Security number, or accession number) and tissue type.

All slides and smears must be received with at a minimum, two patient identifiers (patient first and last name, date of birth, Social Security number, or accession number)

The above procedures must be followed, otherwise the requisition and specimen may be returned to you for appropriate identification with a letter explaining the reason for rejection of the specimen. Additionally, specimens will be rejected when slides are broken beyond repair, a specimen is received in a syringe with an intact needle, or the names on the specimens and requisitions do not match. VERBAL ORDERS: Any additional testing which is verbally requested must be followed up with a written requisition within 2 working days in order to comply with regulatory requirements.

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COURIER SERVICES: When specimens are ready to be picked up, place them in the designated area for courier pick-up. If your office is not on a regular pick-up schedule, call Ameripath Cleveland at 440-703-2150 to request a courier pick-up. Also, call if you have a specimen, which requires immediate pick-up in order to maintain specimen integrity (such as fresh tissue). If you have prior knowledge of such needs, it is preferable to give Ameripath Cleveland 24 hour notice of such special needs. ORDERING SUPPLIES: All clients will be supplied with specimen containers, fixative (10% formalin), bags for submitting specimen containers, supplies for Fed-Ex shippments, and requisition forms.

Fill out the Ameripath Cleveland Supply Requisition form completely, including the office or clinic name, address, phone number, date of order, and contact person.

Indicate the amount of each supply you will need.

Place the supply requisition form in the courier pick-up box, or fax it to 440-703-2155 NOTE: Our policy is to fill all supply requests within 48 hours. If you need the supplies sooner, please call 440-703-2150 and speak to the Client Services Representative. We will make every effort to meet your needs.

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SPECIMENS FOR CYTOLOGY EXAMINATION

(Non-Gyn Only)

GENERAL INFORMATION

For Non-Gynecology specimen types, use the Surgical Pathology Requisition.

A completed AmeriPath requisition form MUST accompany each patient’s specimen(s). In order to ensure positive patient identification, all specimens should be labeled with two patient identifiers patient’s first and last name & date of birth). In order for us to achieve accurate and timely billing of your patients, we must recieve accurate and legibly written patient information. The completed requisition should include the following information:

Complete patient name as it appears on the primary insurance card;

Complete address of the patient;

Patient’s date of birth, age, sex, phone number, and social security number (the social security number is not required but is very useful for patient identification);

Guarantor’s name if other than the patient;

Complete insurance information (a copy of the patient’s insurance card(s), front and back, attached to the requisition, is best);

Appropriate ICD-9 code;

Patient’s clinical history (this is a regulatory requirement because of the importance in aiding accurate diagnosis);

Requesting physician’s first and last name (circle appropriate choice if multiple physician names appear on the requisition);

Names of physician(s) who should receive a copy of the pathology report;

Specimen type and source;

Patient’s Last Menstrual Period, if applicable;

Specimen collection date;

Laboratory procedures or special tests that are desired.

If the information listed above is not complete and legible, processing of the specimen may be delayed while we contact your office by phone or fax to obtain the required information.

Note: The third copy of the requisition is for your office use, and may be disposed of if not needed by your office. A second copy of the requisition is for lab use and must be submitted with the specimen.

Packing the specimen:

Courier pick-up: Place the completed patient requisition into the outer pouch of a zip-lock bag clearly labeled bio-hazard bag (we provide these). Place the primary specimen container into the bag and zip-lock it shut to further prevent any possible leakage. The specimen(s) are now ready for Courier pick-up.

Fed-Ex shipment:

NOTE: We provide Fed-ex canisters, shipping boxes, pre-printed Fed-Ex airbills, and Fed-Ex Express Large Clinical Paks.

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Place the bio-hazard bag (with the specimen and requisition) into the bio-hazard canister. Make sure the lid is closed completely. Place the canister into another bio-hazard plastic bag and ziplock the bag. The canister is then placed into a bio-hazard shipping box (the box has detailed packing instructions printed on the inside). Tape the box shut. Mark all shipping instructions on your pre-printed Fed-Ex airbills (addressed to Ameripath—Cleveland). Attach the airbill to the Fed-Ex Clinical Pak (plastic bag). Place the shipping box into the Fed-Ex Express Large Clinical Pak. Seal the pack by following the instructions on it. Your package is now ready to ship.

For the safety of all personnel involved, do not send sharps (e.g. scalpel blades, syringe needles, etc.) with the specimen, unless it has bearing on the case, such as a foreign body removed from the patient.

NON-GYNECOLOGICAL CYTOLOGY SPECIMENS

SPECIMEN SUBMISSION

Supplies provided by Ameripath for collection include:

Frosted end glass slides for smears

Sterile, 50 cc plastic containers for specimen collection

Plastic, leak-proof slide containers pre-filled with alcohol fixative.

Prefilled CytoLyt collection vials.

Prefilled 95% alcohol slide holder containers.

Plastic, biohazard specimen bag

Non-gynecologic specimens are prepared by cytology personnel under the direction of a Cytotechnologist/ Cytopathologist.

All cytology specimens should be submitted to the laboratory as soon as possible after collection. Delay results in deterioration of unfixed specimens. If delay is unavoidable (more than 1 hour), please refrigerate specimens until they are picked up.

Fluid and mucoid cytology specimens are submitted in CytoLyt® (site-o-lite) preservative. Volume of fixative should be approximately the same or more than the submitted fluid volume. Smear preparations must be immediately spray fixed or placed in alcohol fixative. All cytology specimens should be submitted fresh or with CytoLyt® (site-o-lite) preservative. Clearly label the specimen container or glass slides with patient's first and last name, date of birth, source of specimen and doctor's name. Use only pencil for labeling the frosted end of glass slides.

Do not add Carbowax Fixative (Saccomono Fluid) to a cytology specimen.

The laboratory does not accept syringe needles. Flush the barrel of the needle into the specimen container, using the proper preservative and dispose of the needle into a sharps container.

Specimens should be tightly capped and submitted in approved transport bags. Place the completed requisition in the pouch outside the sealed bag. Transport specimens to the cytology laboratory via courier.

All specimens containers and slides submitted must be labeled with at a minimum, two patient identifiers (patient first and last name, date of birth, Social Security number, or accession number)

If questions arise as to how a cytology specimen should be handled that are not answered in this manual, call 440-703-2100 or 440-703-2183.

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SPECIMEN COLLECTION

Body Cavity Fluids (Pleural, peritoneal and pericardial fluids)

Equipment: clean container (such as a sterile urine container)

Procedure:

1. Perform tap.

2. Place sample in clean container.

3. Have specimen delivered immediately to the laboratory. If there is a delay, add 30 ml CytoLyt® or refrigerate. Please note on the container if CytoLyt® has been added.

Urine

Equipment: AmeriPath Urine Cytology Kit

A voided urine specimen should be obtained after the patient has been well hydrated and approximately three hours after the last void.

DO NOT submit the first morning void for cytology.

Clean catch samples are necessary. Female patients should be instructed to spread the labia during collection, then pass and discard a small amount of urine. Collect the remainder. Males should be instructed to pass and discard a small amount of urine and collect the remainder.

If the patient is unable to cooperate satisfactorily, a catheterized specimen should be obtained. Note the method of collection on the requisition form.

Do not submit 24-hour collection specimens for cytology. These are unsatisfactory due to cellular degeneration.

Procedure:

1. Collect 50-100 ml of urine in labeled collection container.

2. Immediately pour an equal amount of fixative into the kit box and return with specimen.

3. Place cap on urine collection containor and secure tightly.

4. Place urine collection container, along with provided absorbent material, into plastic ziplock specimen bag and seal.

5. Place sealed plastic bag containing the specimen collection container into the Urine Cytology Kit Box.

6. Place completed test requisition into the Urine Cytology Kit Box. Close kit box and tape lid shut.

7. Have specimen delivered to the laboratory immediately.

Urine for UroVysion

Follow the instructions for collecting a urine specimen, indicate the collection technique and place the UroVysion label on the Urine Cytology Kit Box.

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Sputum

Sputum samples should be collected when a pulmonary lesion is suspected. Fresh morning sputums should be collected each day for 3 consecutive days. Post bronchoscopy sputums are also very helpful in the comprehensive evaluation.

Equipment: wide mouth plastic container

Spontaneous Deep Cough Sputum Procedure:

1. Instruct patient to collect specimen as soon as they wake up.

2. Instruct patient to rinse mouth with water, then cough deeply and expectorate into container. Only deep cough material without saliva.

3. Inform patient that several coughs over a period of 2 to 3 hours may be necessary to produce a sufficient sample.

4. Have specimen delivered to the laboratory immediately. If there is a delay of more than 1 hr., collect the sputum specimen in 30 ml CytoLyt® solution and mix well by capping the container tightly and shaking to mix. Please note on the container if CytoLyt® has been added.

5. If three consecutive specimens are to be collected, all three specimens can be delivered on the third day of collection, provided the earlier specimens are fixed with CytoLyt®.

Induced Sputum Procedure:

If the patient cannot spontaneously produce a satisfactory specimen, an induction technique can be used using aerosols, bronchial irritants and mucolytics via an approved procedure by trained personnel.

1. Instruct patient on the procedure.

2. Request the patient to clear his/her throat and rinse mouth with water.

3. Administer the aerosol.

4. Sputum should be expectorated into a collection cup containing CytoLyt® solution

5. Adequate specimen collection may require up to 24 hours after the induction procedure. Instruct patient to collect multiple samples into the fixative if this is necessary.

Cerebrospinal Fluid (CSF)

Equipment: clean container

Submit the largest volume of fluid possible.

Do NOT add CytoLyt® to this specimen.

Procedure:

1. Perform spinal tap.

2. Place sample in clean container.

3. Have the specimen delivered to the laboratory immediately or keep refrigerated until courier pick-up.

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Breast Fluids

Material may be obtained either from secretions expressed from the nipple or by aspiration of cystic lesions.

NIPPLE SECRETIONS

Equipment: glass slides; 95% alcohol or spray fixative

If secretion appears when pressure is applied to a particular area, it is advisable to note this on the requisition form and prepare a specifically identified slide from this material. This may be helpful in guiding future biopsy.

Cellularity tends to increase with each expression and 4-6 slides should be made.

Procedure:

1. Label glass slides with pencil only and include at a minimum, two patient identifiers (patient first and last name, date of birth, Social Security number, or accession number) and specimen source.

2. Express material from nipple by gentle compression of the areolar area between thumb and forefinger directly onto glass slide.

3. Gently spread material over surface of slide.

4. Immediately fix specimen by dropping slide into 95% alcohol or spray with fixative. DO NOT allow specimen to air dry.

BREAST CYST ASPIRATIONS

Equipment: clean container

Most breast cyst fluids do not need cytologic examination and can be discarded particularly those that are clear or green or green-brown in color. A small percentage of breast cysts may harbor a malignancy and it is advisable to submit cysts for cytologic examination particularly in the following circumstances.

Submit the cyst fluid if:

the cyst is subareolar or recurrent

the fluid appears bloody (including hemosiderin containing dark brown fluid suggestive of old bleeding),

the patient is postmenopausal and not on hormone replacement therapy

Procedure:

1. Perform aspiration, withdraw as much fluid as possible.

2. Place specimen in clean container.

3. Have specimen delivered to the laboratory immediately. If there is a delay of more than 1hr, add an equal

Fine Needle Aspiration (FNA) Biopsy

Equipment: glass slides; 22,23 or 25 gauge needles; Aspiration "gun"; syringe to fit into "gun"; alcohol swabs; 4 x 4 cotton gauze pads; slide holder containing 95% alcohol

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Procedure:

1. Localize the lesion by palpation. The lesion must be easily palpable to obtain an adequate specimen.

2. Attach the needle to the syringe, then attach the syringe to the "gun" (if preferred). Inspire a small volume of air into the syringe before aspiration (approx. 2cc). Alternatively the aspiration biopsy can be performed with no air in the syringe, but the needle has to be removed after the biopsy, air drawn into the syringe barrel, the needle reattached and material expressed onto glass slides. CAUTION: When removing and replacing a needle on a syringe use a safety "recapping" device to avoid needle sticks.

3. Localize and stabilize the lesion with one hand. Clean the surrounding skin with an alcohol swab.

4. Insert the needle into the lesion. Apply suction using the thumb on the plunger or by squeezing the trigger on the aspiration "gun".

5. Move the needle back and forth in the lesion, continuosly applying suction and changing the angle of the needle relative to the lesion. Continue applying suction until material is evident in the needle hub. In the aspiration of a solid nodule, a successful aspirate is usually obtained when material appears in the hub of the needle (not drawn into the barrel of the syringe).

6. Release suction before withdrawing the needle. Withdraw the needle and have the patient or an assistant apply pressure to the puncture site with cotton gauze until bleeding stops.

7. Prepare smears by placing a small drop of material near the labeled end of the slide. Draw material gently across the surface of the slide (without applying pressure) using another slide. Quickly place the slides into 95% alcohol fixative supplied by the lab. Prepare 1-3 slides as material allows.

8. expelling cytolyt solution into the and out of the syringe. Any solid tissue fragments may be processed into a cell block at the laboratory.

9. Repeat aspiration 3 times to ensure an adequate specimen is obtained. All of the needle rinses from the

10. Label slides in pencil with at a minimum, two patient identifiers (patient first and last name, date of birth, Social Security number, or accession number) and the site of the specimen (i.e. left breast).

11. Complete the AmeriPath requisition form including clinical impression and all pertinent clinical history. Indicate that the specimen is an FNA and specify the site of the aspiration.

12. Have the specimen delivered to the laboratory for further processing and interpretation.

Specimen Rejection

Following documented attempts to contact the clinician/office and obtain information, specimens will not be accepted for further processing based on these criteria:

Missing Two patient identifiers on slide or specimen container

No patient demographics on requisition

Slide and requisition have been separated and identities cannot be confirmed

No client or physician name on the requisition

Broken slides

Specimen submitted from a non-physician source

Improper preservation or storage of specimen

Improper fixation

Non-Routine Specimen Collection

17

QUICK REFERENCE GUIDE

Commonly used terms:

Specimen: a product of a surgical procedure that is submitted to the laboratory for evaluation. Specimens are usually submitted to the laboratory in a fixative for routine histology, but on some occasions are required to be sent “fresh” (no fixative). Routine Histology: A specimen is submitted to the laboratory in 10% neutral buffered formalin to preserve tissue elements. The specimen is processed, embedded in wax, and cut on a machine to produce a section of the tissue on a glass slide for a pathologist to view under a microscope (microscopic evaluation). Fixative: A reagent used to preserve tissue by stabilizing tissue elements of a specimen. 10% neutral buffered formalin is the most common routine fixative used to preserve tissue submitted to the histopathology laboratory. Fresh tissue: A tissue sample removed from the body for studies other than routine histology. Fresh tissue studies are not possible on 10% neutral buffered formalin fixed tissue. Therefore, the tissue is kept “fresh” by placing it into an acceptable transport media for the type of tissue removed.

Specimens submitted for tests other than routine histology:

Specimen type: Submit the specimen in: For questions, contact:

Fresh tissue (e.g. lymph node for flow cytometry or and cytogenetics)

Saline soaked gauze or tissue transport medium (available from Ameripath Cleveland). Must send by FedEx for overnight delivery.

Latoiya Muse at 440.703.2127. or, if unavailable: Dr. William Katzin 440.703.2160

Urinary Stones for analysis (stones should be dry)

Dry container, such as a sterile plastic container.

Tissue for culture (For example: skin biopsies, wounds, debridements)

Saline soaked gauze placed into a sterile container; also specify on the requisition which type of culture to be performed. (For example, anaerobic/aerobic, fungal, mycobacterial)

Swab for culture Forward the swab culture to your reference lab that performs Microbiology testing. Microbiology testing is not available at AmeriPath Cleveland.

Biopsies for Direct Immunofluorescence (DIF)

Submit the specimen in Michel’s Transport Medium only.

Urate crystals for evaluation (Tenosynovium, Gout)

100% Alcohol (Ethanol)

FNA (Fine Needle Aspirate) Place smears into alcohol. Rinse the needle in CytoLyt® solution.

For any additional questions, please call: 440-703-2100

18

LIMITATIONS OF SPECIMEN

COLLECTION MATERIAL

Collection Type

Storage Requirements

WITH/WITHOUT

Specimen in Collection

Product Additional Requirements

Formalin Jars any size**

Storage Temp= Room

Temperature

Do Not Freeze. If outside temperatures goes

significantly below the recommended temperature

please do NOT put in lock box. Call our lab for a special

pick up inside your office facility/Surgery Center

CytoLyte Solution

Storage Temp= 15-30

degree C Flammable

Cytology Spray Fixative

Storage Temp= Room

Temperature Flammable

Culture Media (Anarobic & Aerobic)

Storage Temp= 5-25

degree C

Cultures must be received by the lab within 24 hours for

processing

Immunofluorescence (Michel's Solution)

Storage Temp= Room

Temperature

Do Not Freeze. If outside temperatures goes

significantly below the recommended temperature

please do NOT put in lock box. Call our lab for a special

pick up inside your office facility/Surgery Center

NOTES

*All collection products must be used within

the expiration date. Use outside the

expiration date will void the testing and

recollection will need to be performed

and/or results with disclaimers will be

supplied (depending on the type of

specimen and collection material in

question)

** The Formalin type we provide to clients

has been validated for testing inside our lab.

Please do NOT substitute other lab's

formalin as it may contain additives that are

not compatible with our testing

Specimen Collection Product Limitations & Requirements

19

590 E. Western Reserve Rd., Bldg. # 57730 First Place, Suite A

Poland, OH 44514Oakwood Village, OH 44146

Phone: 330-965-9954 Fax: 330-965-9958Phone: 440-703-2100 Fax: 440-703-2155

email:

Cleveland DGXCLVClientService@questdiagnostics.com

QTY ITEM QTY ITEM

NON-GYN SUPPLIES FIXATIVE

KIT, AMERIPATH, FINE NEEDLE ASPIRATE (FNA) FORMALIN BIOPSY BOTTLES - 20 ml

CONTAINER, URINE, STERILE FORMALIN BIOPSY BOTTLES - 40 ml

REAGENT, PAP JAR PREFILLED 95% ETHYL ALCOHOL FORMALIN BIOPSY BOTTLES - 60 ml

SOLUTION, COLLECTION CYTOLYT FORMALIN BIOPSY BOTTLES - 120 ml

ESOTERIC SUPPLIES FORMALIN BIOPSY BOTTLES - 240 ml

UROVYSION COLLECTION & TRANSPORT KITS FORMALIN BIOPSY BOTTLES - 480 ml

COLLECTION, IHCSPECIMEN TRANPORT KIT PROSTATE BIOPSY KITS 8 BOTTLES

KIT, IMMUNOFLOUORESENCE (DIF) PROSTATE BIOPSY KITS 14 BOTTLES

SWAB, CULTURETTE, RED AMIES REQUISITIONS, FORMS & DATA SHEETS

SWAB, CULTURETTE, BLUE AMIES REQUISITIONS (SPECIFY):

KIDNEY STONE STRAINER PATIENT I.D. LABELS for SPECIMEN BOTTLES (30/SH)

Afirma Thyroid FNA Transport Kit SUPPLY ORDER FORMS

BIOHAZARD BAGS REMOTE PRINTER PAPER

BIOHAZARD SPECIMEN BAGS (6X11) OTHER

BIOHAZARD SPECIMEN BAGS (9X11) S-LOCKBOX, FLOOR, 11.5X11.5X9 (NO CLIPS) W/KEYS

BIOHAZARD SPECIMEN BAGS (12X18) PRINTER CARTRIDGE OKI C330 (circle color: C, M, Y, BL)

BIOHAZARD SPECIMEN BAGS (18X18) PRINTER CARTRIDGE HP4600 (circle color: BL)

SHIPPING SUPPLIES PRINTER CARTRIDGE HP3600 (circle color: C, M, Y, BL)

COOLER, W/BOX EPS 8X6X9

COOLER, 24X16X12 3/8 W/BOX

CLINICIAN:_________________________PHONE #: __________________________DATE:________________

ADDRESS:___________________________________________________________________________________

The supplies provided by our company to you are solely to be used for the collection and preparation of specimens w hich are being sent

to our laboratory for testing. It is not intended that these supplies be provided for any other uses, and such limitation is necessary to

comply w ith appropriate law s.

SUPPLY ORDER FORM