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DIRECTORY OF SERVICES

REVISED JANUARY 2017

2 DIRECTORY OF SERVICES

DIRECTORY OF SERVICES 1

GENERAL COMPANY OVERVIEW ................................................................................................ 3

COMPANY CONTACT INFORMATION ........................................................................................ 4

ACCREDITATION AND LICENSURE ............................................................................................. 5

CORPORATE AND MEDICAL STAFF ............................................................................................ 6

RESULTS AND REPORTING ............................................................................................................ 6

CASE MANAGEMENT, TEST ADD-ONS AND CANCELLATIONS ......................................... 7

INFORMATION TECHNOLOGY ....................................................................................................... 7

INSURANCE AND BILLING SERVICES ........................................................................................ 8

GENERAL SPECIMEN LABELING AND SUBMISSION ........................................................... 9

SURGICAL PATHOLOGY ................................................................................................................ 10Cervical, Endocervical and Endometrial ....................................................................................... 10Cone and LEEP Conization of Cervix .............................................................................................. 10Endoscopic........................................................................................................................................ 10Skin Excisions ....................................................................................................................................11Breast Tissue ......................................................................................................................................11Prosthetic Breast Implants .............................................................................................................. 12

IMMUNOHISTOLOGY, CYTOCHEMISTRY, MOLECULAR PATHOLOGY ........................... 12Immunohistology ............................................................................................................................. 12Molecular Oncology ......................................................................................................................... 13Chromosomal Studies and Electron Microscopy ......................................................................... 13

HEMATOPATHOLOGY AND FLOW CYTOMETRY .................................................................... 14Flow Cytometry ................................................................................................................................ 14How to Submit a Bone Marrow Biopsy and Aspirate ................................................................... 16How to Submit Tissue for Lymphoma (Lymph Node/Solid Tissue) Workup ............................... 16

INFECTIOUS DISEASE TESTING ................................................................................................. 17UniSwab™ ........................................................................................................................................ 17ThinPrep® and SurePath™ .............................................................................................................. 18Group A Streptococcus Swab (ESwab) .......................................................................................... 18Group B Streptococcus Swab ......................................................................................................... 18Self Collection Device ...................................................................................................................... 19Urine Preservative Transport (UPT) ................................................................................................ 19

CYTOPATHOLOGY (NON-GYN).................................................................................................... 20Induced Sputum and Bronchial Washings for Pneumocystis Pneumonia ................................ 20Bronchial, Colonic, Esophageal and Gastric Washings ............................................................... 20Sputum ............................................................................................................................................. 20Urine ................................................................................................................................................. 21Nipple Secretions and Smears ....................................................................................................... 22Cerebral Spinal Fluid ....................................................................................................................... 22

CONTENTS


CONTENTS


CYTOPATHOLOGY – FINE NEEDLE ASPIRATION ..............................................................................23Thyroid/Parathyroid FNA – Thyroglobulin Assay Option (UniPath Only) ...............................................26

CYTOPATHOLOGY – GYNECOLOGY .....................................................................................................27ThinPrep® Pap Tests .................................................................................................................................... 27SurePath™ Pap Tests .................................................................................................................................. 28Human Papillomavirus (HPV) Testing .......................................................................................................29HPV and Pap Co-Testing .............................................................................................................................30Pap Smears for Diethylstilbestrol (DES) Evaluation ................................................................................31 Conventional Method ............................................................................................................................31 Liquid Based Method .............................................................................................................................31

THE BETHESDA2014 SYSTEM FOR REPORTING CERVICAL/ VAGINAL CYTOLOGIC DIAGNOSES .............................................................................................................32

PAP SMEAR COMMENTS – THE BETHESDA2014 SYSTEM...............................................................34

PEDIATRICS – PLACENTA SERVICE ......................................................................................................36

PEDIATRIC/PERINATAL AUTOPSIES .....................................................................................................37

APPENDICES ................................................................................................................................................44Appendix 1: Immunopathology Library of Antibodies ........................................................................... 45Appendix 2: Immunohistochemistry/Molecular Prognostic Markers.................................................... 49Appendix 3: Special Stains .........................................................................................................................50Appendix 4: Hematopathology Diagnostic Profiles .................................................................................51Appendix 5: Available Molecular Tests ......................................................................................................52Appendix 6: Aperio Scan Scope AT ...........................................................................................................53Appendix 7: Maturation Index and Other Estrogen Effect Indicators ....................................................54Appendix 8: Additional Forms ...................................................................................................................55 Supply Order Forms ...............................................................................................................................55 Advanced Beneficiary Notice of Noncoverage (ABN) ........................................................................58 Add-on Requests ....................................................................................................................................59 Requisitions ............................................................................................................................................59Appendix 9: Reference Laboratory Information .......................................................................................60 Counsyl ....................................................................................................................................................60 Interpace Diagnostics .............................................................................................................................60 MDxHealth ..............................................................................................................................................60 NeoDiagnostix ........................................................................................................................................61 Progenity .................................................................................................................................................61 Sequenom ...............................................................................................................................................62 University of Colorado ...........................................................................................................................62Appendix 10: Laboratory Test Directory (Alphabetical Order) .................................................................63 (includes specimen preparation and rejection criteria)

Contents, Cont.

CONTENTS


American Pathology Partners (AP2) is an emerging nationwide network of leading anatomic

pathology laboratories serving physician offices, hospitals, and surgery centers. Our passion is superior patient care. AP2 strives to accomplish this by helping clinicians provide the best treatments possible to their patients. This means providing treating physicians and their staff accurate, definitive and informative diagnoses, rapid turnaround times, and superior service levels.

Our goal is to provide academic-caliber, subspecialized pathology services by pairing these capabilities with academic-caliber medical consults and interpretation services through affiliated but independent, physician-owned medical practices.

Our board-certified, fellowship trained, pathologist partners have extensive training and experience in several subspecialty areas, including surgical pathology, breast pathology, cytopathology, dermatopathology, hematopathology, urologic pathology, gastrointestinal and liver pathology, nephropathology, pediatric and perinatal pathology, immunopathology, and molecular diagnostics.

AP2 is committed to delivering quality patient care through teamwork and exceptional laboratory services.

CORE VALUES➤ COMMUNICATION

We support consistent open dialogue company-wide.

➤ SERVICE We set the standard of excellence and build long-lasting relationships through efficiency and reliability.

➤ TEAMWORK We treat each other with respect to promote a collaborative environment.

➤ PASSION We celebrate enthusiasm, fun and the recognition of our accomplishments.

➤ ACCOUNTABILITY We are responsible for accuracy, ownership and attention to detail.

➤ INNOVATION We continuously improve through creative

ideas and advancing technology.

QUALITYAP2 incorporates extensive quality control and quality assurance during all phases of operation. Interdepartmental process evaluation is conducted regularly and improvements are implemented and identified. AP2 and its subsidiaries have developed departmental committees to interpret statistics, recommend new monitors, discuss resolution of and follow-up on identified problems, and explore ways of improving quality, efficiency, and cost effectiveness.

GENERAL COMPANY OVERVIEWGENERAL COMPANY OVERVIEW


AMERICAN PATHOLOGY PARTNERS, INC. CORPORATE HEADQUARTERS103 Continental Place, Suite 400, Brentwood, TN 37027www.ap2.comMain Telephone: 615.916.3200 Fax: 615.916.3218

UNIPATH6116 East Warren Avenue, Denver, Colorado 80222-5703www.unipathdx.com

PALM BEACH PATHOLOGY2013 Ponce de Leon Ave., West Palm Beach, Florida 33407www.pbpdx.comMain Telephone: 615.916.3200 Fax: 615.916.3218

UNIPATH LABORATORYToll Free: 866.864.7284Front Desk: 303.512.0888Fax: 303.512.2288Hours: 8am-5:30pm (MST) Monday-Friday

INFORMATION TECHNOLOGYHelp Desk: 303.512.2263

CLIENT RELATIONS:Department: 303.512.2210Fax: 303.512.2252Hours: 8am-5:30pm (MST) Monday-Friday

CYTOLOGY/HISTOLOGYMain Laboratory: 303.512.0888

HEMATOLOGY/FLOW CYTOMETRYHotline: 855.823.6555Email: [email protected]

MOLECULARMain Laboratory: 303.512.0888

ADDITIONAL SERVICESSupplies Department: 303.512.2216Fax: 303.512.2246Add-on Testing: 303.512.2210

NATIONAL BILLING CENTERHotline: 855.307.5899Hours: 7am - 4pm (MST), Monday - Friday

COMPANY CONTACT INFORMATION

COMPANY CONTACT INFORMATIONPALM BEACH PATHOLOGY LABORATORYToll Free: 800.749.6595Front Desk: 561.659.0770Fax: 561.659.0413Hours: 8am - 5:30pm (ET), Monday - Friday


CLIENT RELATIONSDepartment: 561.659.0770Hours: 8am - 5:30pm (ET), Monday - Friday

CYTOLOGY/HISTOLOGY: Main Laboratory: 561.659.0770




NATIONAL BILLING CENTERHotline: 855.307.5899 Hours: 9am - 5pm (ET), Monday-Friday

http://www.ap2.com/

http://www.unipathdx.com

http://www.pbpdx.com

mailto:hemepath%40unipathdx.com?subject=



EASTERN CAROLINA PATHOLOGY2693-B Forest Hills Road, Wilson, North Carolina 27893www.ecpdx.com

EASTERN CAROLINA PATHOLOGY LABORATORYToll Free: 866.572.8452Front Desk: 252.234.2841Fax: 252.234.9270Hours: 8am - 5pm (ET), Monday - Friday


CLIENT RELATIONSDepartment: 252.234.2841Hours: 8am - 5pm (ET), Monday - Friday

CYTOLOGY/HISTOLOGYMain Laboratory: 252.234.2841




NATIONAL BILLING CENTERHotline: 855.307.5899Hours: 9am - 5pm (ET), Monday-Friday

ACCREDITATION AND LICENSURE

AP2 has three laboratory facilities and staffs other various sites including local hospitals and surgery centers. AP2 physicians hold appropriate medical and facility accreditations for the jurisdictions served. In compliance with the requirements of the accrediting agencies listed below, AP2 laboratories maintains ‘inspection readiness’ status at all times and participates in on-site inspections and external/internal proficiency testing as required and administered through these jurisdictions.

UNIPATH 6116 East Warren Ave. Denver, CO 80222

Clinical Laboratory Improvement Amendments (CLIA) License No: 06D0512826

College of American Pathologists (CAP) Participant No: 2178701

State of Florida License No: 800026147

PALM BEACH PATHOLOGY2013 Ponce de Leon Ave. West Palm Beach, Florida 33407



State of Florida License No: 800001121

EASTERN CAROLINA PATHOLOGY2693-B Forest Hills Road Wilson, North Carolina 27893



PATHOLOGIST LICENSUREAP2’s physicians, practitioners and laboratories hold licenses in several states. Please contact Client Relations for a comprehensive, up-to-date list.

ACCREDITATION AND LICENSURE

Note: Many extensions are equipped with voicemail, but you always have the option of speaking with one of our many dedicated and courteous employees who will help resolve your questions or problems. If you feel that your needs are not being satisfied, please ask for a member of the administrative staff or the pathology Medical Director.

http://www.ecpdx.com



Please visit our laboratory websites to learn more about our Corporate and Medical staff at:

AP2: www.ap2.com

UniPath: www.unipathdx.com

Palm Beach Pathology: www.pbpdx.com

Eastern Carolina Pathology: www.ecpdx.com

OUR STAFF

OUR STAFF | RESULTS AND REPORTING

RESULTS AND REPORTINGAP2 generates final diagnostic reports as quickly as possible while maintaining quality and service. AP2 is in compliance with the Health Insurance Portability and Accountability Act (HIPAA), and all policies, processes and procedures are designed to ensure compliance with HIPAA standards. All AP2 processes and procedures are monitored and audited for HIPAA compliance, and AP2 employees receive training on HIPAA standards annually.

The Client Relations staff is trained to answer many of your questions. If he/she does not know the answers to your questions, they will find out the necessary information and get back to you in a timely manner. AP2 professional staff members, including board-certified, fellowship trained pathologists and certified cytotechnologists, are available to assist with consultations on interpretation of results and reports and technical concerns. Please feel free to communicate any questions or concerns to your client service representative or pathologist at:

UniPath 303.512.0888Palm Beach Pathology 561.659.0770Eastern Carolina Pathology 252.234.2841

TURN AROUND TIMEAP2 and its subsidiaries strive to provide the most rapid turn-around time possible without compromising quality. In general, tissue biopsies and critical cytology specimens are given priority, due to their serious nature. Pathology reports will typically be generated within 48 hours of receipt of the specimen. Routine Pap screening cytology

reports will be available within 4-5 working days after receipt of the specimen. STAT processing and reporting are also available for special circumstances.

ISSUING REPORTSDelivery of reports can be made a number of ways:

➤ Courier service

➤ United States Mail

➤ Auto fax

➤ On-site remote printing

➤ Electronic file transfers

➤ LifePoint Web-Based Reporting

MONTHLY STATISTICAL REPORTSMonthly reports specific to your practice are available upon request. Reports such as diagnostic statistics specific to your practice and lists of patients with diagnostic information are two examples of reports we can provide. Please contact Client Relations for more information.

PATHOLOGY DIRECTED CONSULTATIONSOccasionally, a specific case may require a second opinion from outside AP2’s pathology group. AP2 reserves the right to select the experts used for consultative services. Additional consultative expenses will be the responsibility of the patient or their insurance carrier.

SLIDE RE-CUT PROGRAMExtra slides on cases may be requested by clinicians for study, second opinion or retention

http://www.ap2.com

http://www.unipathdx.com

http://www.pbpdx.com

http://www.ecpdx.com


CASE MANAGEMENT, TEST ADD-ONS AND CANCELS | INFORMATION TECHNOLOGYin your own files. Slides will be re-cut on request and sent along with the completed pathology report. A nominal fee may be assessed. For more information, please contact Client Relations.

MEDICAL LEGAL TESTINGAP2 laboratories do not perform testing for medical legal purposes.

INFECTIOUS MATERIALAP2 laboratories are anatomic, cytology and molecular diagnostic laboratories only. Group B Streptococcus testing is the only test that requires culturing prior to molecular testing.

Specimens for routine culturing should be referred to a clinical reference laboratory specializing in microbiology. Specimens for KOH preps or wet mounts should also be directed to a clinical microbiology laboratory.

SPECIMEN PROCESSING SERVICESurgical specimen processing without diagnosis is available. AP2 laboratories can provide specimen gross examination, tissue processing, slide preparation and labeling. This service is exceptionally useful to dermatologists who have specialty training in dermatopathology and wish to microscopically examine and diagnose their own patient’s specimens.

CASE MANAGEMENT, TEST ADD-ONS AND CANCELLATIONSFor cases that require a test be canceled or for additional testing to be added, please contact Client Relations as soon as possible at:


Testing will only be performed with clear orders. Verbal orders must be followed up with a signed authorization before testing will be performed.

INFORMATION TECHNOLOGY

DEDICATED IT PERSONNELAP2 operates a large IT department, including IT professionals that provide support in a number of areas: lab informatics, EHR interfacing and client connectivity, network administration, data center operations, database administration, decision support, help desk support, etc. AP2 provides the infrastructure and support that healthcare providers need to access laboratory information.

FLEXIBLE CONNECTIVITY SOLUTIONSAP2 IT Department provides this deep expertise and knowledge base to every client connectivity project. We expeditiously and expertly develop

customized connectivity solutions that meet your needs. We employ every modality available and provide our clients the utmost flexibility when it comes to placing orders and receiving results.

MULTIPLE OPTIONSOrders can be placed manually using our well-designed hardcopy requisition forms or electronically (either via our browser-based online portal or via an order interface from an EHR system). Results can be delivered hardcopy via courier, via fax, auto-print to a remote dedicated in-office printer, via a browser-based online portal, via a results interface into an EHR system, or any combination of the above.


INSURANCE AND BILLING SERVICESAP2 participates with many insurance companies and holds many managed care contracts. You do have a choice when it comes to selecting a laboratory for your anatomic pathology and cytology specimens. A list of the current managed care contracts is available upon request. Please contact Client Relations for an updated list and/or any questions that you may have about a specific insurance company.

The billing statement your patients receive represents the pathology fee for professional and technical services associated with the evaluation of a specimen, tissue, blood or bodily fluids submitted to one of our partner laboratories, including UniPath, Palm Beach Pathology or Eastern Carolina Pathology. These laboratory facilities are members of American Pathology Partners (or AP2).

We know that having to deal with medical bills is not particularly enjoyable. Our commitment to every patient is to help them through this process with sensitivity, care and professionalism. Please contact us about any billing related matters:

National Billing Center1.855.307.5899 (toll-free)8:00am – 5:00 pm (CT), Monday – [email protected]

In order to bill appropriately and completely, please submit complete and accurate billing information on the test requisition and include a copy of the patient’s insurance card(s), front and back. The following elements must be included:

➤ Specimen collection date

➤ Complete patient name

➤ Patient gender

➤ Patient date of birth

➤ Ordering physician full name and NPI

➤ Patient telephone number

➤ Subscriber name (if different than patient)

➤ Subscriber date of birth (if different than patient)

➤ Complete address of patient or subscriber

➤ Relation to subscriber (self, spouse, child, other)

➤ All ordering ICD-10 diagnosis codes

➤ Insurance company name and address (copy of front and back of insurance card)

FINANCIAL HARDSHIP PATIENTSAP2 recognizes the inability of some patients to pay for necessary anatomic pathology and cytology screening services. This also includes uninsured and underinsured patients who are not covered for specified anatomic pathology and cytology screening services. AP2 provides a financial assistance program for patients who are eligible. Please call the billing phone number for the appropriate laboratory for more information.

THIRD PARTY CARRIERSAP2 will bill a patient’s third party carrier directly. This requires complete and accurate information and copies of the front and back of the patient’s insurance cards. If the patient has a third party insurance carrier contracted with the AP2 laboratory which their specimen was sent, AP2 will accept 100% of the contracted price for a test. AP2 will bill according to the explanation of benefits (EOB) provided by the carrier and will also bill for co-pays, co-insurance, deductibles and non-covered services as instructed by the carrier and required by law.

MEDICAREAP2 is a participating Medicare supplier with the Medicare program and is required by CMS to file all claims for laboratory services rendered. AP2 accepts the Medicare-allowed amounts as full payment for covered services. This assignment does not preclude billing of the patient for services denied by Medicare.

Medicare only pays for those services that it deems to be medically necessary for the diagnosis

INSURANCE AND BILLING SERVICES

mailto:billinginquiries%40ap2.com%20?subject=

https://www.peryourhealth.com/


and treatment of diseases and/or other health related problems. CMS and Medicare have developed a system using ICD-10 diagnosis codes to prevent payment of claims that they determine not to be medically necessary. It is critical that a code used for ordering the anatomic pathology service/test be consistent with the documentation in the patient’s medical records. The ICD-10 code or clinical description used must be specific to the patient’s medical condition and the anatomic pathology service/test requested by the physician

for that date of service. If reimbursement is denied due to lack of medical necessity, Medicare rules allow the laboratory to subsequently bill the patient only if the patient has signed and dated the Advanced Beneficiary Notice (ABN) prior to the testing procedure. A copy of the ABN form can be found in Appendix 8. To comply with HCFA guidelines for Medicare reimbursement, please be certain to include the appropriate ICD-10 code or clinical description, as well as have the patient sign the ABN.

GENERAL SPECIMEN LABELING AND SUBMISSION

GENERAL SPECIMEN LABELING AND SUBMISSIONPrudent medical-legal practice and laboratory accrediting agencies have strict guidelines for specimen labeling and submission. They also mandate rejection of improperly completed requisitions or incorrectly identified slides or specimens. For example, some specimens cannot be analyzed because of improper collection, preservation or degradation in transit. Other specimens may have prolonged turn-around-times because of lack of necessary patient information. Still other specimens will, by necessity, be rejected because of inaccurate or absent specimen and/or requisition labeling. You will be notified of rejected or problematic specimens upon receipt. To avoid delayed diagnoses and potential specimen rejection, please observe the following requirements:

SURGICAL, CYTOLOGY AND MOLECULAR (UNISWAB AND GBS) SPECIMENS

REQUISITION

1 Patient last name, first name

2 Date of birth

3 Collection date

4 Physician and clinic name and address

5 Insurance and/or billing information including name of insured, subscriber

number, group number, name and address of insurance company, and IPA group (if applicable) – copy of insurance card preferred.

6 Reason for testing/ICD-10 code

7 Test order

8 Site and type of biopsy if surgical specimen

9 Type of specimen and site of collection if cytology/molecular specimen

10 Brief clinical history

11 Requests for any special stains or studies

SPECIMEN CONTAINER

1 Patient last name, first name (last name and first initial are acceptable) on the body of container (not the lid)

2 Second identifier such as date of birth, chart number, SS# or other unique identifier required

3 Specimen type and/or location (i.e. skin lesion, left shoulder etc.)

VIALS/NON-GYN SLIDES

1 A #2 lead pencil is recommended for slides. Markers and ballpoint pens are unacceptable for slides because of wash off during


BIOPSY – ROUTINE CERVICAL, ENDOCERVICAL AND ENDOMETRIAL

MATERIALS REQUIRED

1 Collection container(s) with 10% formalin

2 Requisition form

PROCEDURE

1 Label the body of the collection container(s) (not the lid) with the patient’s name, second identifier and tissue identification.

2 Complete the requisition form including tissue type, patient name, complete address, birth date, date of service and billing data.

3 Provide clinical history, i.e. last menstrual period, prior biopsies or Pap smear information, and any history of hormone use including birth control pills on the requisition form.

4 Immediately place the specimen in the collection container, tightly close container lid and forward to laboratory with requisition.

Note: Use of gauze pads to hold or place endometrial and endocervical samples are discouraged because portions of the specimen are absorbed into the coarse weave and lost. Telfa is acceptable; placing the specimen directly into formalin is preferred.

BIOPSY – CONE AND LEEP CONIZATION OF CERVIXMATERIALS REQUIRED


2 Requisition form

PROCEDURE

1 Label the collection container(s) with the patient’s name, second identifier and tissue identification.

2 Complete the requisition form including tissue type, patient name, complete address, birth date, date of service and billing data.

2 Include on the requisition a history of prior Pap smear or biopsy results.

4 Orient cone specimen with surgical suture material is preferred.

5 Immediately place the specimen in the collection container, tightly close container lid and forward to laboratory with requisition.

BIOPSY – ENDOSCOPIC (ESOPHAGUS, GASTRIC, SMALL AND LARGE INTESTINE, LUNGS, ETC.)MATERIALS REQUIRED:


2 Telfa

3 Requisition form

SURGICAL PATHOLOGY

SURGICAL PATHOLOGY

processing. Also, a name written on top of fixative will wash away with the fixative during processing.

2 Fixed smears: Write “Fix” on the fixed slide frosted end. Smear the material onto the glass slide (may use a 2-slide pull technique) and drop immediately into specimen container with fixative.

3 Non-fixed, air-dried smears: Smear the material onto the glass slide (may use a 2-slide pull technique) and allow to air dry, then place into a cardboard slide holder.

General Specimen Labeling and Submission, Cont.


PROCEDURE

1 Label the body of the collection container (not the lid) with patient’s name, second identifier and tissue identification.

2 Complete requisition form including tissue type, patient name, complete address, birth date, date of service and billing data.

3 Place specimen directly into formalin, close lid tightly and forward to laboratory.

4 If you choose to use Telfa, gently orient and place tissue on Telfa, mucosal surface up with submucosal surface in contact with the Telfa. Slowly enter the Telfa with attached tissue into the formalin, tightly close lid and forward to laboratory with the requisition.

Note: Use of gauze pads to hold or place endoscopically obtained specimens is discouraged because portions of the specimen are absorbed into the coarse weave and lost. Telfa is acceptable; placing the specimen directly into formalin is preferred.

BIOPSY – SKIN EXCISIONS

MATERIALS REQUIRED:


2 Requisition form

PROCEDURE

1 Label the collection container(s) (not the lid) with the patient’s name, second identifier and tissue identification.

2 Complete requisition form including tissue type, patient name, complete address, birth date, date of service and billing data.

3 Include on the requisition form any clinical history, a gross description of lesion and history of prior biopsies if available.

4 Indicate if specimen is a shave, punch or excision.

5 Orient specimen as necessary using description or surgical suture material. Immediately place the specimen in the fixative container.

6 Tightly close the container and forward to laboratory with requisition.

BIOPSY – BREAST TISSUEMATERIALS REQUIRED:

1 Collection container(s) filled with 10% neutral-buffered formalin large enough to completely submerge specimen in adequate volume of fixative (10:1)

2 Requisition form completed with the following:

a Patient identifiers and billing information

b Relevant history

c Anatomic site of biopsy

d Time tissue was removed from patient

e Time tissue was submerged in fixative

PROCEDURE

1 Label the collection container(s) with the patient’s name, second identifier and anatomic site of the biopsy/sample.

2 Note on the requisition the time the specimen was removed from the patient.

a The time between removal from the patient to submerging in fixative (cold ischemic time) should be less than 1 hour.

3 Immediately place the specimen in the formalin-filled container and tightly close the container lid.

a The volume of formalin to tissue should be 10:1 and should completely cover the specimen and allow the tissue to float.

4 Note on the requisition form the time and date the specimen was placed in formalin.

a Inadequate formalin volume and/or failure to provide formalin fixation time may delay processing and the ability to perform special studies.

5 Complete the requisition form with all required information (see above).

6 Forward the specimen and completed paperwork to the laboratory as soon as possible.


Surgical Pathology, Cont.

BIOPSY – PROSTHETIC BREAST IMPLANTS

MATERIALS REQUIRED

1 Collection containers for implants (submitted without fixative) and containers for fibrous tissue capsules submitted in 10% formalin

2 Completed requisition form

PROCEDURE

1 Label the collection containers (not the lid) with the patient’s name, second identifier and specimen identification.

a The prosthetic breast implants must be submitted in separate containers without fixation.

b The fibrous tissue capsules may be submitted separately in 10% formalin.

2 Complete the requisition form to include tissue type, patient name, date of birth, date of service, and billing insurance data.

3 Indicate on the requisition the presence or absence of prosthetic rupture or leakage.

4 Tightly close container lids and forward to laboratory with requisition.

IMMUNOHISTOLOGY, CYTOCHEMISTRY, MOLECULAR PATHOLOGY

IMMUNOHISTOLOGY, CYTOCHEMISTRY, MOLECULAR PATHOLOGY

IMMUNOHISTOLOGY

PRINCIPLEImmunohistology employs highly specific monoclonal antibodies to detect protein antigens in pathologic material to demonstrate specific types of cellular differentiation. Molecular pathology uses specific DNA probes to identify genetic material, to associate a disease process with an infectious agent or rearrangement of genetic material.

Cytochemistry employs specific chemical reactions to demonstrate sub-cellular organelles or enzymes, which might be associated with certain types of cellular differentiation. These special studies are useful in establishing the correct diagnosis for a wide variety of pathologic conditions. These studies are also useful in determining a patient’s prognosis for a given tumor, such as status of estrogen and progesterone receptors for breast carcinoma. Finally, these studies are also useful in helping the pathologist to determine if a given histologic pattern represents a malignancy, such as a demonstration of prostatic gland basal cells.

MATERIALS REQUIRED

1 Collection container filled with 10% buffered formalin for specimens not suspected of being lymphoma or leukemia (see next line). The pathologist will determine if these special studies are needed

2 Sterile collection container lined with saline soaked gauze for cases suspected of lymphoma or leukemia

3 Glass slides with frosted end for cytology specimens such as Fine Needle Aspirations or bone marrow aspirates

4 A completed requisition form with proper patient identification, history and source of biopsy

PROCEDURE

1 Label the collection container (not the lid) with the patient’s name, second identifier and tissue identification.

2 Submit routine biopsy material in 10% buffered formalin unless lymphoma or leukemia is suspected. The pathologist will


determine if special studies are required after studying the routine preparation.

3 For suspected lymphomas, place the fresh tissue in a clean container, which does not contain any fixative material. The tissue should be placed on gauze dampened with saline.

4 Let smears air dry at room temperature. Place them in a plastic slide box. If you do not have a box, simply wrap the slides up in a paper towel or tissue paper and secure with tape.

5 Complete the requisition form to include patient name, date of birth, date of service and billing data. The pathologist will determine if additional studies are needed after initial examination of the specimen.

6 Contact laboratory Courier Services to arrange for a STAT pick up:


7 Please note that we can accept specimens Monday through Friday only, from 7:00 a.m. to 4:00 p.m. Advanced warnings about specimens being sent fresh for Lymphoma work-ups ensures the specimens will be properly processed upon receipt at the laboratory. If unsure of proper submission, please call prior to biopsy excision.

MOLECULAR ONCOLOGY

PRINCIPLEMolecular Oncology uses molecular methods to characterize genetic material, or to detect infectious agents. These special studies are useful in helping the pathologist determine which translocation occurred or what gene amplified, deleted, etc.

TESTING IS CURRENTLY PERFORMED TO EVALUATE

1 Breast cancer Her2Neu status

2 Jak 2 quantitative Polymerase Chain Reaction (send-out)

3 Human papillomavirus high risk detection

4 Various genetic rearrangement in hematologic malignancies

MATERIALS REQUIRED

➤ Tissue Biopsies:

1 A tissue specimen that has been processed and is in a paraffin block or unstained slides cut from a paraffin block.

2 A completed pathology request form with insurance information or copies of insurance information attached.

➤ Blood:

1 5 - 10 mL blood specimens should be collected in EDTA tube (purple top). Heparin samples are NOT acceptable.

CHROMOSOMAL STUDIESCurrently, AP2 does not perform chromosomal studies on tissue or fluid specimens “in house”. If requests for chromosome studies are received, we will forward them to a reference laboratory. Specimens for chromosomal analysis (i.e. Products of Conception) must be submitted fresh in saline or RPMI (without formalin) in an appropriately labeled container and accompanied by a completed requisition form requesting Chromosomal Analysis. If CombiMatrix Product of Conception microarray testing is desired, specimen can be received in fresh saline, RPMI or formalin. Information on AP2 reference laboratories and specimen collection guidelines can be found in Appendix 9.

ELECTRON MICROSCOPYCurrently, AP2 does not perform “in-house” Electron Microscopy on tissue or fluid specimens. If Electron Microscopy is requested or required to complete a diagnosis, we will refer to a reference laboratory. Specimens for Electron Microscopy must be submitted in gluteraldehyde. Generally, Electron Microscopy is clinically necessary only for complete evaluation of medical kidney disease. Coordination of preparation and submission of specimen can be accomplished best by contacting the pathologist at the appropriate medical facility prior to collecting the specimen.


HEMATOPATHOLOGY AND FLOW CYTOMETRYFLOW CYTOMETRY OVERVIEWPRINCIPLEFlow cytometry measures physical and chemical properties of the cells. The cells pass the flow cytometric analyzer in a fluid, single-cell stream. The laser beams interrogate each cell and indicate the cell size, internal complexity and the antigens present on cell surface or in the cytoplasm.

METHODOLOGYEach specimen is manually processed. A smear (peripheral blood or bone marrow) or touch prep (tissue) slide is made from the original specimen. A cytospin slide is made from the final cell suspension. The slides are stained and evaluated by the hematopathologist. Every specimen for flow cytometric analysis is manually processed. Panels of surface/intracellular markers are chosen to stain the cells based on morphology and clinical history. After the cells are stained, they are acquired and analyzed with the flow cytometer.

Our immunophenotyping panel configurations are carefully considered based on state-of-the-art scientific references, consensus, and the experiences of our hematopathologists. The combinations of antibodies allow for the identification of normal and abnormal populations of cells within a specimen. Our antibody panels cover acute leukemia, chronic leukemia, T and B cell lymphoma, multiple myeloma, neoplasms and others.

FLOW CYTOMETRY/HEMATOPATHOLOGY GENERAL SPECIMEN REQUIREMENTSREQUISITION

1 Patient last, first name

2 Date of birth

3 Collection date and time

4 Physician and clinic name and address

5 Insurance and/or billing information including name of insured, subscriber number, group number, name and address of insurance company, and IPA group (if applicable) – copy of insurance card preferred.

6 Reason for testing/ICD-10 code

7 Test order

8 Type and collection site of specimen

9 Brief clinical history (including CBC)

10 Requests for any special stains or studies

11 DART: If this box is checked, the hematopathologist will use discretion to determine which tests are appropriate, based on specimen type and clinical history, and order tests appropriately.

BONE MARROW/PERIPHERAL BLOOD SLIDES All bone marrow/peripheral blood slides submitted must be legibly labeled with the patient’s name (last name and first name initial are acceptable) matching the requisition form. Minimally, the last name must be legible and correctly spelled. A second identifier such as date of birth, chart number or other unique identifier is required.

SPECIMEN CONTAINERS

1 Patient last name, first name (last name and first initial are acceptable)

2 Second identifier such as date of birth, chart number or other unique identifier is required

3 Specimen type and collection site (i.e. peripheral blood, bone marrow; right iliac crest, etc.)

PERFORMED

➤ Monday – Friday, STAT on-call available weekends

TURNAROUND TIME

➤ Verbal results usually available within 24 hours of specimen receipt

BONE MARROW

1 2-7 mL bone marrow aspirate collected in NaHep (green top) tube; EDTA (purple top) tube acceptable; ACD (yellow top) tube only if no other options are available

HEMATOPATHOLOGY AND FLOW CYTOMETRY


2 Call lab immediately for STAT pickup:


3 Specimen needs to be delivered to lab immediately (within 12 hours) and transport at room temperature (20-25ºC).DO NOT REFRIGERATE.

PERIPHERAL BLOOD

1 3-5 mL collected in NaHep (green top) tube

2 3-5 mL collected in EDTA (purple top) tube for morphology

3 Deliver within 24-hours of collection

4 Transport at room temperature (20-25ºC). DO NOT REFRIGERATE.

5 Include CBC results if performed

SOLID TISSUE/FNA

4 5 mm solid tissue specimen cut aseptically into small pieces and placed in RPMI media and stored at refrigerated temperature of 2-8ºC

4 FNA specimen placed in RPMI media and stored at refrigerated temperature of 2-8ºC

4 Transport on “wet” ice. DO NOT SEND ON DRY ICE AND DO NOT FREEZE.

BODY FLUIDS

1 Volume required for testing depends on the cell count of the specimen. Specimen handling varies depending on the specimen type.

2 Cerebral Spinal Fluid (CSF) requires processing within one hour of collection for optimal results. Please call laboratory for details:


PROCESS AND HOLDSOccasionally a physician may submit a specimen for possible flow cytometry, depending on the results of permanent section expected at a later time. In these cases, “Process and Hold” is written usually on the

requisition. The specimen typically will be held for 2-3 days, during which time the physician must contact the laboratory to request flow analysis. A specimen may also be sent with a diagnosis that does not warrant flow cytometry testing (Hodgkin lymphoma, carcinoma, certain body fluids, etc.) These specimens are held until reviewed by the pathologist. If no further testing is requested, “CANCELED by (pathologist name)” will typically be written on the requisition in red ink with the date and the technologist initials. The paperwork is filed and the specimen is kept for approximately one week and then discarded.

SPECIMEN REJECTIONA specimen may be rejected if it is frozen or fixed, too old, or if it is hemolyzed or clotted. All specimens MUST be labeled with at least the patient’s name and date of collection. Other identifying information is useful, such as hospital number.

SPECIMEN REQUISITIONPlease use the comprehensive hematopathology requisition. Please indicate specimen type, number and type of tubes, and number of smear or touch prep slides submitted. It is important to indicate the diagnosis under consideration and the indication for flow cytometry testing.

The following information must be completed on each requisition:

1 Patient’s name

2 Patient’s date of birth

3 Hospital number or accession number (if available)

4 Social security number (if available)

5 Date and time of collection

6 Specimen source or type (i.e. bone marrow, left cervical lymph node, etc.)

7 Requesting physician name and contact phone number

8 Thorough clinical history

9 Indicate whether flow cytometry is needed

All insurance information must be included to ensure proper billing.


HEMATOPATHOLOGY AND FLOW CYTOMETRY

Hematopathology and Flow Cytometry, Cont.

HOW TO SUBMIT A BONE MARROW BIOPSY AND ASPIRATEMATERIALS REQUIRED

1 Hematopathology requisition form, with labels for patient name, specimen designation, time specimen was collected, and biohazard bags

2 Formalin (ECP only) or B-Plus fixative (UniPath and PBP)

3 2-5 mL of peripheral blood submitted in EDTA tube (purple top) for morphology (and/or 3-5 mL of peripheral blood in NaHep (green top) for flow cytometry if aspirate not obtainable (dry tap)

4 Copy of CBC results is required

5 Two purple top (EDTA) tubes of aspirate (one for morphology, one for molecular testing)

6 Two green top (NaHep) tubes:

a 3-6 mL of aspirate for cytogenetics

b Minimum 1 mL of aspirate for flow cytometry

7 In event of a DRY TAP (no aspirate obtainable):

a Submit 3-5 mL of peripheral blood in green top (NaHep) for flow cytometry.

b Submit a separate 10 mm core biopsy in sterile RPMI.

8 If marrow submitted for STR studies, use yellow top tube (ACD) (transplant patients).

9 If marrow cultures are needed, aspirate should be placed in yellow top isolator tubes (saponin anticoagulant, NOT ACD).

PROCEDURE

1 Label the collection containers (not the lid) with the patient’s name, second identifier and specimen identification.

2 Complete the hematopathology requisition form including tissue type, patient’s name, complete address, birth date, date of service, and billing data, as well as any

other physicians who need copies of the report.

3 Request studies in the test menu or check DART.

4 After preparing 5 touch imprints, the bone marrow core biopsy should be immediately placed in the formalin (ECP only) or B-Plus fixative (UniPath and PBP). Note the time of fixation on the requisition form.

5 Express bone marrow aspirate material into two purple top tubes (EDTA) and two green top tubes (NaHep), cap and gently mix to prevent clotting.

6 The peripheral blood specimen should be placed in a purple top tube (EDTA).

7 Place all the specimen tubes and the requisition form in a biohazard bag.

8 Call laboratory to arrange for a STAT pickup:


Note: Bone marrow biopsy specimens are performed for a variety of reasons ranging from evaluation of anemia to the diagnosis of metastatic carcinoma and leukemia. Complete patient history, as well as documentation of any supporting details is vital to the complete and accurate interpretation of the material. It is of particular importance to include information as to growth factor therapy.

HOW TO SUBMIT TISSUE FOR LYMPHOMA (LYMPH NODE/SOLID TISSUE) WORKUPMATERIALS REQUIRED:

1 Sterile screw top container

2 RPMI (preferred) or if not available, sterile isotonic saline

3 Formalin or B-Plus fixative (for UniPath clients)

4 5 glass slides


6 Biohazard bags

7 Ice


INFECTIOUS DISEASE TESTINGPROCEDURE

1 Label the collection container (not the lid) with the patient’s name and identification.

2 Make touch preparations of the lymph node or tissue, using the 5 glass slides.

3 Place a portion of the lymph node or tissue (5 mm of fresh tissue, cut aseptically into small pieces) in the screw top container and cover with RPMI (or wet with saline). DO NOT SUBMIT ALL TISSUE IN FORMALIN OR B-PLUS IF FLOW ANALYSIS IS DESIRED.

4 Place remainder of lymph node or tissue into B-Plus fixative (UniPath and PBP) or formalin (ECP).

5 Fill out requisition and include name of primary care physician or oncologist.

3 Place RPMI container in biohazard bag filled with ice. Place B-Plus or formalin container into a biohazard bag with touch preparations.

6 Specimen should be received within 30-minutes of excision for optimal results. Call laboratory for STAT pickup:


7 For a complete list of Hematopathology Diagnostic Profiles, please see Appendix 5.

INFECTIOUS DISEASE TESTINGINFECTIOUS DISEASE OVERVIEWInfectious disease testing can be performed on the ThinPrep®, SurePath™, UniSwab™, GBS Swab and Urine Preservative collection devices. Select testing is offered off the BD self-collection device and Eswab.These molecular tests aid in the detection, diagnosis and treatment of viral, fungal and bacterial infections. Nucleic acid testing is performed using polymerase chain reaction (PCR), loop-mediated DNA amplification (LAMP), strand displacement amplification (SDA), transcription mediated amplification (TMA) and hybrid capture methodologies providing high levels of sensitivity in testing for the presence of these organisms.

A full list of tests offered using the ThinPrep®, SurePath™, UniSwab™, Urine Preservative, GBS Swab, Self-Collection, and Eswab collection devices can be found in Appendix 5 of this manual.

UNISWAB™ COLLECTION

PURPOSE

1 For female patients, collection of cervical and vaginal specimens, including lesions

2 For male patients, collection of discharge from urethra or lesions

PROCEDURE

1 Completely fill out Women’s Health or Cyto/Histo requisition form with proper patient identification, history and collection source.

2 Aseptically remove sterile swab from package.

3 Collect specimen by vigorously swabbing site for 30 seconds.

4 Aseptically remove cap from vial.

5 Place swab in transport medium and break off swab against rim of tube.

6 Replace cap to vial and close tightly.

7 Fill out vial label with patient information.

FOR HSV SAMPLES – PLEASE USE UNISWAB™ FOR SPECIMEN COLLECTION

1 For crusted lesions, pre-moisten the swab with either sterile saline or sterile water.

2 De-roof the crust, and swab the lesion firmly working from outer base of lesion to interior.


3 Place swab into transport media, break off swab against rim of the tube.

4 Replace cap to vial and close tightly.

5 Fill out vial label with patient information.

THINPREP® PAP TESTS AND SUREPATH™ PAP TESTSPURPOSE

1 For female patients, collection of cervical and vaginal specimens

PROCEDURE

1 Completely fill out the Women’s Health or Cyto/Histo requisition form with proper patient identification, history and collection source.

2 Label vial with patient information and second identifier.

3 Prior to specimen collection, clean away any visible blood, mucus and/or discharge from the cervix.

4 Obtain a vaginal smear from secretions in the posterior fornix. This material, along with the ectocervical scrape should be placed immediately in the vial and agitated to dislodge the collected cells. Shake vigorously.

5 Collect sample from the endocervix with a cytobrush or broom.

6 For SurePath specimens, place the brush or broom into the vial and agitate it up and down against the bottom of the container to collect as much material as possible. For Thin Prep specimens, swirl brush multiple times into the collection container and then remove collection device.

7 Close vial tightly and place in specimen bag.

GROUP A STREPTOCOCCUS SWAB (ESWAB)Testing for Group A Streptococcus is only offered off the Eswab collection device. Any other swab used will not be acceptable for testing at AP2 laboratories.

PURPOSE

1 For female and male patients, collection of throat specimen

PROCEDURE

1 Completely fill out the Women’s Health or Cyto/Histo requisition form.

2 Label Eswab collection device with patient identification and second identifier.

3 Remove cap from vial.

4 Collect specimen from throat lesion area.

5 Place swab in transport medium, replace cap to vial and close tightly.

6 Leave specimen at room temperature or refrigerate.

7 Specimen pick up should occur within 24 hours.

GROUP B STREPTOCOCCUS SWABA separate collection device is required for the molecular diagnostic test for Group B Streptococcus (GBS). Per the recommendations by the Centers for Disease Control (www.cdc.gov, 2010), molecular tests for GBS should be performed from specimens enriched by bacterial media, refrigerated and transported in order to obtain maximal sensitivity. Do not use a UniSwabTM, ThinPrep® or SurePathTM swab for GBS collection.

GBS COLLECTIONPURPOSE

1 For female patients, collection of vaginal and rectal specimens

MATERIALS

1 GBS collection device and transport media

PROCEDURE

1 Completely fill out the Women’s Health or Cyto/Histo requisition form with proper patient identification, history and collection source.

2 Label GBS vial with patient information and second identifier.

INFECTIOUS DISEASE TESTING

Infectious Disease Testing, Cont.


3 Aseptically remove sterile swab from package.

4 Collect specimen from vagina and rectum (collect from vagina first followed by rectum). Both sites are required for adequate results.

5 Aseptically remove cap from vial.

6 Place swab in transport medium and replace cap to vial and close tightly.

7 Refrigerate immediately per recommendation of CDC.

8 Specimen must be delivered to laboratory within 48 hours.

9 Please refer to the Centers for Disease Control website (www.cdc.gov) for more information.

SELF-COLLECTION DEVICEIn select circumstances, utilization of the vaginal self-collection device is optimal for female patients of a young age or those uncomfortable with a pelvic exam. Only the BD self-collection device provided by AP2 laboratories may be used for this test offering. The self-collection device must never be sent home with a patient for collection; collection must occur at the physician office.

PURPOSE

1 For female patients, collection of vaginal specimen

2 For female patients of young age or those uncomfortable with a pelvic exam

PROCEDURE

1 Completely fill out Women’s Health or Cyto/Histo requisition form with proper patient identification, history and collection source. Write in “self-collection device” near source information.

2 Label collection device with patient identification and second identifier.

3 Patient should be instructed by physician or office staff on how to properly collect a vaginal specimen (inserted two inches into vagina, gently rotate swab for 10-15 seconds against vaginal wall, remove without touching skin).

4 After collection, immediately place swab in collection tube and tighten the cap.

5 The specimen must be processed within 14

days of collection.

URINE PRESERVATIVE TRANSPORT (UPT)

PURPOSE

1 For female and male patients, collection of free-catch urine

2 For female patients who have had a hysterectomy

PROCEDURE

1 Label collection cup with patient identification, second identifier, date and time collected.

2 Collect specimen in a sterile, plastic, preservative-free specimen collection cup.

a Patient should collect the first 20-60 mL of voided urine.

3 Place cap securely on urine collection cup.

4 Open the Urine Preservative Transport Kit (UPT) and remove the UPT from the packaging.

5 Label the UPT with patient identification, second identifier, date and time collected.

6 Hold the UPT upright and firmly tap the bottom of the tube on a flat surface to dislodge and drops from inside the cap.

7 Mix the specimen. Use the transfer pipette to aspirate urine from the urine cup.

a Urine stored at 2-8oC: Transfer to UPT within 24 hours of collection.

b Urine stored at 2-30oC (ambient temperature): Transfer to UPT within 8 hours of collection.

8 Dispense urine into the UPT. Fill UPT between the black lines on the fill window located on the UPT label. This volume corresponds to approximately 2-3 mL of urine. DO NOT under-fill or over-fill the tube. Discard the pipette.

a Specimens that are under filled or overfilled will not be processed.

9 Tighten the cap securely on the UPT. Invert the UPT 3-4 times to ensure that the specimen and reagent are mixed well.

http://www.cdc.gov


CYTOLOGY – INDUCED SPUTUM AND BRONCHIAL WASHINGS FOR PNEUMOCYSTIS PNEUMONIAMATERIALS REQUIRED

1 Leak proof specimen container

2 Requisition form

PROCEDURE1 Label specimen containers (not the lid)

with precise identification of specimen site (i.e. right upper lobe of lung). Add patient name and second unique identifier such as date of birth or social security number.

2 Complete requisition form including patient name, date of birth, date of service and billing information. Include requests for “Pneumocystis jiroveci” (formerly carinii) pneumonia (R/O PCP).

3 Enter washings into specimen container.

4 If brushings are performed concurrently, rotate brush gently over slide to apply material and let air dry.

5 Place brush in CytoLyt® container.

6 Submit to laboratory with completed requisition form.

Note: Specimens may be submitted “fresh” without fixative. If delay is anticipated, add equal amounts of 50% methyl or ethyl

alcohol or CytoLyt®. Refrigerate if specimen delivery is delayed. Only induced sputums or bronchial lavage/wash specimens are acceptable for ruling out PCP. Routine sputums to rule out PCP are rarely sensitive enough to yield reliable results.

CYTOPATHOLOGY – BRONCHIAL, COLONIC, ESOPHAGEAL AND GASTRIC WASHINGSMATERIALS REQUIRED

1 Leak proof specimen container

2 Preservative fluid (50% methyl or ethyl alcohol, or CytoLyt®). DO NOT use SurePath™ Pap test vials.

3 Slides with frosted ends (if brushings obtained concurrently)

4 Requisition form

5 Pencil for labeling slides

PROCEDURE

1 Label specimen containers (not the lid) with precise identification of specimen site (i.e. right upper lobe of lung, etc.). Add patient name and second unique identifier such as date of birth or social security number.

2 Label slides with patient’s name using a pencil.

3 Complete the requisition form including patient name, birth date, date of service and billing data. Include requests for special stains or studies (i.e. Pneumocytis jiroveci or fungus).

4 Enter washing into specimen container and add equal volumes of preservative.

CYTOLOGY – SPUTUMMATERIALS REQUIRED

1 Leak proof plastic container with CytoLyt® fixative

2 Requisition form

PROCEDURE

1 Label collection container (not the lid) with patient’s name and second unique identifier such as date of birth or social security number.

2 Complete requisition form including patient name, birth date, date of service and billing data.

3 If the specimen is one of a series of samples taken, indicate position in series (i.e. 1/3 if it is the first of three samples).

4 Have the patient rinse their mouth prior to collection.

5 Give the patient the collection container.

6 Instruct the patient to breathe deeply for 3 minutes.

CYTOPATHOLOGY (NON-GYN)



7 Instruct the patient to cough deeply from the diaphragm, with effort to expectorate material into collection container.

8 At short intervals, repeat the coughing attempts three more times with collection of all coughed up material.

9 Add equal volumes of specimen to fixative fluid and shake vigorously (make sure that the container lid is tightly sealed before shaking).

10 Forward specimen to the laboratory with the completed requisition form.

COMMENTS

1 Deep cough (from the diaphragm) specimens are necessary to provide information regarding the lower respiratory tract. The laboratory will determine adequacy of specimen by the presence of alveolar macrophages within the specimen.

2 A series of three sputum samples should be collected on three consecutive days, preferably first thing in the morning with hard, productive coughing is recommended. Morning collections take advantage of the accumulation of secretions during the night. Avoid collecting right after meals to avoid contamination with food particles.

3 If there is difficulty in producing a specimen, collections may be facilitated by the moisture and steam of a preceding, long hot shower. For patients who are unable to produce sputum with repeated attempts, consider aerosol induced coughing and specimen collection.

4 Post bronchoscopy sputums may be productive with diagnostic material even with negative bronchial washings, brushings and biopsies.

5 Specimen consisting of saliva or nasal pharyngeal drainage will be reported as lacking alveolar macrophages, metaplastic cells or bronchial columnar cells. These specimens are inadequate for lesions of the lower respiratory tract and will not be considered as true negative studies.

6 With sputum samples positive for

malignant cells, a primary of the head and neck region should be considered as well as malignancies of the lung. Up to 10% of positive sputums may reflect malignancies of the head and neck.

7 Specimens requiring culture must be separately submitted in sterile containers without fixative. The culture specimens must be submitted to a laboratory specializing in microbiologic culturing.

8 Specify the need for asbestos body examination. Studies will include examination of Papanicolaou and Prussian blue stained smears.

9 Specify the need for identification of pneumocystis jiroveci. Specimens will include examinations of Papanicolaou, Diff Quick and GMS as needed. The specimens submitted for pneumocystis should be submitted fresh without fixative.

CYTOLOGY – URINEMATERIALS REQUIRED

1 Leak proof collection container

2 Appropriate fixative (50% ethyl or methyl alcohol or CytoLyt®)


PROCEDURE

1 Label collection container (not the lid) with the patient’s name and second unique identifier such as date of birth or social security number.

2 Complete the requisition form, including patient name, date of birth, date of service and billing data. Patient’s history of kidney or bladder abnormalities should also be noted.

3 Patient preparation: Instruct the patient to void and discard the first morning specimen. The patient should drink at least a quart of water an hour prior to collecting the urine specimens.

4 Mix an equal amount of fixative with the urine specimen. Forward the specimen to the laboratory with the completed requisition form.


5 In some cases, separate specimens should be collected and dated for consecutive days.

COMMENTS

1 Urine should be identified as to type of sample (i.e. voided, catheterized, right or left ureteral or bladder irrigation fluid).

2 For detection of cancer of ureters or kidneys, a serial collection of specimens spaced over three days has proven to increase diagnostic sensitivity and yield.

3 Sensitivity and yield of urine specimens has also been shown to increase with optimal collection and preservation of specimen.

4 Unpreserved urine results in the rapid degeneration of exfoliated cells and may become useless in diagnosis.

CYTOLOGY – NIPPLE SECRETIONS AND SMEARSMATERIALS REQUIRED

1 Slides with frosted ends

2 Physiologic saline

3 Cotton swab

4 Requisition form

5 Pencil for labeling slides

PROCEDURE

1 Label the slides with the patient’s name and site from which sample obtained using pencil. Example: “R Breast”.

2 Complete the requisition form, including the patient name, birth date, date of service and billing data. Include any pertinent history on the requisition (especially if the patient is pregnant or lactating).

3 If there is no nipple erosion or ulceration, gently “strip” the area of the breast below the nipple and areola with a motion from beneath the areola towards the nipple surface. Do not massage the entire breast. The stripping motion will propel

accumulated secretions within the ampulla of the larger excretory ducts.

4 With appearance of fluid on the nipple surface, touch a slide to the drop of fluid and draw the slide quickly across the nipple.

5 Using a separate slide, repeat this process for the opposite breast.

6 If there is nipple erosion or ulceration, touch a slide to this area three times, with a different part of the slide in contact each time. This is conveniently done, starting with a contact position close to the hand holding the slide and then moving the application area of the slide further with your hand for the next two samplings.

7 Following touch preparation (6) of the ulcerated area, try to express fluid (3) and prepare slides if fluid is obtained.

8 If no fluid can be expressed, a swab may be dipped in saline and gently rolled and rotated on the ulcerated surface and applied to a glass slide.

9 Place the slides in the slide container and forward to the laboratory with the completed requisition.

Note: We recommend completely air-drying the smears to avoid incomplete fixation artifact.

CYTOLOGY – CEREBROSPINAL FLUIDMATERIALS REQUIRED

1 Leak proof collection container

2 RPMI (if hematopoietic disease is suspected)

3 Requisition form

PROCEDURE

1 Label the specimen container(s) (not the lid) with the patient’s name, second unique identifier such as date of birth or social security number and specimen site.

2 Complete the requisition form, including the patient name, date of birth, date of service and billing data. Include all pertinent history, especially suspected


Cytopathology (Non-Gyn), Cont.


CYTOPATHOLOGY – FINE NEEDLE ASPIRATIONhematopoietic disease.

3 If hematopoietic disease is suspected, place up to 2mL in separate RPMI container. Submit remaining fluid unfixed in leak proof container. CSF specimens for flow cytometric analysis need to be submitted within an hour of collection for optimal results.

4 Place in refrigerator while waiting for transport.

5 Call laboratory for STAT pickup:


CYTOPATHOLOGY – FINE NEEDLE ASPIRATION


PRINCIPLE

Fine needle aspiration (FNA) provides a prompt, cost effective, and relatively safe means of evaluating a mass through cytologic diagnosis. The procedure is generally well tolerated by patients. FNA is often used as an alternative to surgery and may provide a definitive diagnosis that will determine therapy and/or assist in a planned surgical approach with optimal utilization of operating room time. In general, any palpable mass can be evaluated by aspiration techniques. With ultrasound guidance, fluoroscopy and CT, most deep lesions may also be sampled. Lesions that are commonly sampled include thyroid, breast, salivary glands and lymph nodes. Although the technique is relatively simple, it does require some practice and understanding of principles of aspiration.

MATERIALS REQUIRED

1 Hand grip syringe holder of preference2 Syringe, screw lock, disposable 10mL or

20mL plastic with tight fitting barrel3 Needles of size preference. Most aspirates

may be obtained with a needle no larger than 21 gauge. Most highly vascular structures (i.e. thyroid) are best sampled with a 23 or 25 gauge needle.

4 Frosted end labeled slides and pencil for labeling slides

5 Specimen container with appropriate

fixative as needed for needle washings (CytoLyt®)

6 Alcohol or iodine solutions for sterilization of skin

7 Cotton swabs for sterilization of skin8 Sterile gauze9 Adhesive tape10 Band-Aids11 RPMI for lymph node flow12 Requisition form

PROCEDURE

1 Using a pencil (ink or markers wash off during staining) label slides and specimen container(s) with the patient’s name and precise site of aspiration. Add a second unique identifier such as date of birth or social security number on container(s).

2 Place labeled slides in rows of four slides, each row for use with a “pass”. Use the container with the fixative for needle washings.

3 Set up a sterile field including preparation of syringe and syringe holders for initial and repeat passes.

4 Select preferred needles and syringes to be used for the procedure.

5 Place patient in a comfortable sitting or reclining position that allows easy access to aspirate the lesion.


6 Palpate the mass to identify the depth of the target and its relationship to surrounding structures.

7 Clean the skin over the aspiration site with an alcohol swab.

8 Immobilize the mass with the thumb and index finger of one hand or between two fingers of one hand.

9 Take the syringe equipment in the opposite hand and use a one handed withdrawal and release manipulation of the syringe plunger.

10 Place the needle against the skin at a determined puncture site and insert it into the mass area with a single quick motion without negative pressure on the syringe.

11 Once the needle is in the desired area, retract the plunger of the syringe to create negative pressure in the syringe and needle lumen. Minimal negative pressure is needed for highly vascular organs such as the thyroid while more negative pressure is needed for dense fibrous organs like the breast.

12 Move the needle back and forth several times directing it in the same plane. Gently redirect the needle to increase the field of sampling but avoid vigorous redirection of the needle as this tends to produce unnecessary hemorrhage in the lesion.

13 When material appears in the hub of the needle, the aspiration has been completed. Excess blood in the material will dilute the specimen rendering it unsuitable for microscopic diagnosis. One drop of material can usually produce 4-6 smears.

14 Release the pressure in the syringe by releasing the syringe plunger.

15 Gently withdraw the needle from the lesion and apply pressure to the puncture site with sterile gauze.

16 If multiple sites are sampled, label the slides, containers and corresponding sites on the requisitions A, B, C etc. as needed.

SMEAR PREPARATION

1 After the needle has been removed from the mass, detach the needle from the syringe using a surgical clamp or other appropriate instrument, fill the syringe with air, and reattach the needle to the syringe.

2 Place the bevel of the needle against a glass slide and express a small drop of aspirated material onto the slide.

3 If too much material is expressed onto the slide, either re-aspirate a portion of the material by withdrawing the syringe plunger slightly, or spread the material out among additional slides.

4 If the cellular material is semi-solid, place a second slide on top of the material and pull the slides gently and quickly apart as the material spreads from the weight of the slide.

5 If the aspirated material is diluted by fluid or by blood, use the same smear technique as for blood smears.

6 Place a second slide onto the drop of material allowing it to spread. Gently pull the two slides apart.

7 Slide preparation:

a Allow the smears to air-dry for Diff Quick staining. Write “air dried” on the end of the smear slides.

– OR –

b Prepare the smears as a wet fix.

8 Rinse the needle and syringe into the CytoLyt® vial for monolayer preparation.

9 If staining and immediate evaluation is available, have the patient remain while adequacy of the aspiration pass is determined and repeat the procedure until the operator is satisfied with the adequacy of the material.

10 Complete the requisition form. Include the patient’s name, birth date, date of service and billing data. Provide the exact site of the lesion (i.e. parotid, thyroid, lymph node, etc.).


Cytopathology – Fine Needle Aspiration, Cont.


COMMENTS

1 When the lesion is composed of solid tissue, the needle tip functions as a cutting instrument. As it is moved back and forth through the tissue, tiny tissue fragments become dislodged and collect inside the needle. When suction is added to this procedure the previously dislodged fragments are sucked into the needle and the tip of the attached syringe.

2 The needle should never be removed while any negative pressure is in the syringe. Such pressure may force aspirated material from the needle into the syringe. This may make preparation of smears difficult and may start air-drying the material.

3 It is important not to dilute the cellular material with fluid or blood.

4 If a cyst is encountered during the aspiration, evacuate all fluid from the cyst and perform a second aspiration on any

residual mass. Express the fluid from the cyst into CytoLyt® or 50% methyl or ethyl alcohol.

5 If blood is aspirated into the syringe, stop the procedure and prepare slides. Express residual bloody fluid into CytoLyt® or 50% methyl or ethyl alcohol.

6 If pus is encountered, withdraw as much of the material as possible and perform a repeat aspiration in an adjacent area. (When an infectious process is included in the differential diagnosis, a culture of the aspirated material is often desirable).

7 Necrosis generally occurs in the center of large lesions because of an inadequate blood supply. If the first sample yields only necrotic debris, another sample obtained tangentially to the edge of the mass should be secured.

8 Local anesthesia is rarely required, as the discomfort caused by is application is about the same as the aspiration. Its use is dependent on the lesion location, the discomfort of the patient and the judgment of the operator.

9 Passing through layers of muscle while inserting the needle adds significantly to the discomfort of the patient, while making needle placement more difficult and uncertain. Also, small fragments of muscle may plug the needle, jeopardizing subsequent sampling of the target. The muscle and lesion may sometimes be manipulated so that aspiration technique does not involve the muscle.

10 The nipple and areola of the breast are the areas most sensitive to pain from a needle stick. These areas should be avoided whenever possible. Masses in these areas can sometimes be pushed away from the nipple, immobilized and sampled through adjacent skin.

11 When a mass is located close to the chest wall, there is a possibility that the needle may penetrate and cause a pneumothorax. This can be avoided by moving the mass sideways so it rests on a rib. This not only prevents penetration of the chest wall, but also provides good support for


immobilization of the target.

12 Complications can vary as to the site of aspiration and cannot all be listed. The aspirator should be aware of these prior to aspiration and communicate them to the patient.

13 When completing the requisition, it is vital to provide the exact site of the lesion (i.e. thyroid, lymph node, parotid, etc.). “Neck mass” provides insufficient information for the cytopathologists to provide a reasoned diagnosis.

14 For thyroid aspirations, it is important to provide further information including the number of nodules present and the results of a scan if it was performed.

15 For lymph node aspirations, history of prior malignancy, antibiotic treatment, etc. are important. Flow cytometry can be performed on FNA’s of lymph nodes if the specimen is properly collected and stored. Prior planning can often alleviate the need for a repeat aspiration or biopsy.

Note: We perform FNAs at many of our covered hospitals. The results are generally available the next business day.

THYROID/PARATHYROID FINE NEEDLE ASPIRATION – THYROGLOBULIN ASSAY OPTION UNIPATH ONLY

BACKGROUND

Thyroglobulin and parathyroid assays are available on needle-rinsed FNA material. Some patients, status-post thyroidectomy for differentiated (functioning) thyroid carcinomas, are often followed using serum thyroglobulin (Tg) as a marker of tumor recurrence. Patients with elevated serum thyroglobulin levels are often further evaluated by use of ultrasound radioactive iodine scans, or PET/CT scans. Enlarged lymph nodes or nodules in the bed of the thyroid can often be sampled by fine needle aspiration making use of cytology as well as the newly available direct thyroglobulin levels on the aspirate material. The assay is useful in those cases where

residual/recurrent disease is suspected, but cytology specimen is negative. To take advantage of this added, sensitive technique of detecting recurrent disease, the following procedure is detailed. Special Note: The thyroglobulin assay is not recommended in cases in which the patient is not status post thyroidectomy.

The procedures for sending samples for parathyroid hormone and thyroglobulin are identical.

PROCEDURE1 Identify areas of suspicion, including

enlarged lymph nodes or nodules in the bed of the resected thyroid. These can be sampled under ultrasound guidance via fine needle aspiration (FNA).

2 Prepare cytologic preparations utilizing only direct smears (2 smears per aspirate). Label slides with pencil.

3 Rinse the remaining needle aspirate material rinsed into normal saline (1 cc). Additional aspirates of the targeted lesion may be pooled in this saline rinse. See Fine Needle Aspiration.

4 Additional aspirates for routine cytology can also be collected in CytoLyt®, but is not required in these particular situations.

5 Collect an additional pass in RPMI if hematopoetic lesion is suspected.

6 Contact client services for pick-up of the smears and needle rinse specimens. If pick-up is delayed more than 2 hours, the needle rinse material should be frozen.

UniPath 303.512.0888


Cytopathology – Fine Needle Aspiration, Cont.


CYTOPATHOLOGY – GYNECOLOGYCYTOPATHOLOGY – GYNECOLOGYCYTOLOGY – THINPREP® PAP TESTS™PRINCIPLEAutomation and new methodologies are dramatically changing gynecological cytology, particularly the Pap test. The FDA has approved the ThinPrep® Pap Test™ as a replacement for the conventional Pap smear. Studies indicate that it is more accurate than the conventional Pap smear in detecting premalignant and malignant lesions. The advantages of a monolayer slide include:

1 Reduction of obscuring inflammation and blood

2 Elimination of air drying artifact provided the specimen is placed in the fixative immediately after sampling

3 A more uniform and representative sampling of the collected specimen

4 Residual sample available to perform additional testing as needed

5 Lowering of the ASCUS rate since air-drying and obscuring inflammation are not present

6 Increased sensitivity in detecting High-Grade Dysplasia due to the greater ease in recognizing dysplastic cells on the ThinPrep® Pap Test™ monolayer slide

MATERIALS REQUIRED

1 The collection kit includes a cervix brush with a spatula or broom and a collection vial of PreservCyt®


PROCEDURE

1 Patient preparation:

a Schedule the patient for sample collection mid cycle (obscuring blood from menstrual smears is a major source of less than optimal smears).

b Instruct the patient in advance not to douche for at least 24 hours prior to examination.

2 Label PreservCyt® vial with the patient’s name and second unique identifier such as date of birth or social security number.

3 Complete requisition form including patient name, date of birth, date of service and billing data. Include on the requisition all clinical information (LMP, hormone use, prior Pap smear and biopsy results).

4 Prior to specimen collection, clean away any visible blood, mucus and/or discharge from the cervix.

5 If desired, use lukewarm water to warm and lubricate the speculum. When

AT THE LABORATORY

1 The laboratory will prepare the cytologic smears for interpretation. In the event no metastatic carcinoma is identified, the saline rinse material will be forwarded to University of Colorado Health Science Center (UCHSC) for thyroglobulin testing.

2 Results of the thyroglobulin testing will be added to the original cytology interpretation report as an addendum/consolidated report.

PATIENT MANAGEMENT INFORMATION

The presence of thyroglobulin (> 1.0 ng per mL) in the aspirate material of athyrotic patients is presumptive evidence of metastatic disease even in the absence of cytologic findings of metastatic disease. The estimated sensitivity of this procedure is 100% with specificity of 96.2%. Billing for this procedure will be assigned to your patient’s insurance per usual custom. Saline collection devices can be obtained through your laboratory. For more information or to set up the additional reflex testing, please contact your client service representative.


necessary, a small amount of carbomere-free lubricant can be applied sparingly in a thin layer to the exterior of the speculum blades, avoiding the tip.

6 Obtain an adequate sampling from the ectocervix using a plastic spatula. Select contoured end of plastic spatula and rotate 360 degrees around the entire exocervix while maintaining light contact with exocervical surface.

7 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.

8 Obtain an adequate sampling from the endocervix using an endocervical brush device. 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.

9 Rinse the brush as quickly as possible in the PreservCyt solution by rotating the device in the solution 10 times while pushing against the vial wall. Swirl the brush vigorously to further release material. Discard the brush.

10 Close the vial tightly, and place it with a requisition form into a specimen bag and forward to laboratory.

Note: Although formal maturation indexes (M.I.) cannot be performed on the ThinPrep® Pap Test™ specimen, estimated estrogen effect can be performed which may provide clinically useful information. Please see Appendix 7 for more information on maturation indexes and other estrogen effect indicators.

CYTOLOGY – SUREPATH™ PAP TESTSNote: SurePath™ vials should NOT be used for non-gyn specimens.

PRINCIPLEAutomation and new methodologies are dramatically changing gynecological cytology, particularly the Pap test. The FDA has approved SurePath™ Pap Test as a replacement for the conventional Pap Smear and as an alternative to the ThinPrep® Pap Test™. Studies indicate that it is more accurate than the conventional Pap

smear in detecting premalignant and malignant lesions. The advantages of this technology include:

1 Reduction of obscuring inflammation and blood

2 Elimination of air drying artifact provided the specimen is placed in the fixative immediately after sampling

3 A more uniform and representative sampling of the collected specimen

4 Residual sample available to perform additional testing as needed

5 Lowering of the ASCUS rate since air-drying and obscuring inflammation are not present

6 Increased sensitivity in detecting High Grade Dysplasias due to the greater ease in recognizing dysplastic cells on the SurePath™ Pap Test slide

MATERIALS REQUIRED1 The collection kit includes a cervix brush

with a spatula or broom and a SurePath™ collection vial


PROCEDURE

1 Patient preparation:

a Schedule the patient for sample collection mid cycle (obscuring blood from menstrual smears is a major source of less than optimal smears).

b Instruct the patient in advance not to douche for at least 24 hours prior to examination.

2 Label PreservCyt® vial with the patient’s name and second unique identifier such as date of birth or social security number.

3 Complete requisition form including patient name, date of birth, date of service and billing data. Include on the requisition all clinical information (LMP, hormone use, prior Pap smear and biopsy results).

4 Prior to specimen collection, clean away

CYTOPATHOLOGY – GYNECOLOGY

Cytopathology – Gynecology, Cont.


any visible blood, mucus and/or discharge from the cervix.

5 Insert brush into the endocervical canal.

6 Rotate the brush 5 times in a CLOCKWISE direction.

7 Disconnect the entire head of the brush from the stem and drop into the SurePath™ preservative vial.

8 Close the vial tightly, and place it with a requisition form into a specimen bag and forward to laboratory.

Note: Although formal maturation indexes (M.I.) cannot be performed on the SurePath™ Pap Test specimen, estimated estrogen effect can be performed which may provide clinically useful information. Please see Appendix 7 for more information on maturation indexes and other estrogen effect indicators.

CYTOLOGY – HUMAN PAPILLOMAVIRUS (HPV) TESTING PRINCIPLE

HPV testing is performed directly from the ThinPrep® Pap Test™ PreservCyt® collection vial, SurePath™ collection vial, or Digene specimen transport medium using:

1 Hologic Aptima (ThinPrep® only)

2 Roche Cobas HPV (ThinPrep® and SurePath™)

3 Digene Hybrid Capture II HPV DNA Assay (ThinPrep®, SurePath™ and Digene STM).

The National Institutes of Health have concluded that HPV is present in at least 93 percent of cervical cancers. Using a HPV assay will help rapidly categorize women diagnosed with Atypical Squamous Cells of Undetermined Significance (ASCUS) Pap Tests into those who should proceed directly to colposcopy, and those who may be good candidates for more conservative follow-up.

SINGLE SAMPLE SYSTEM PROVIDES

1 Convenience: simplifying HPV risk assessment for ASCUS patients. The HPV Assays are performed from the same sample collected for a Liquid Based Pap test.

2 Efficiency: provide rapid, objective HPV analysis of ASCUS patients, leading to fewer

follow up procedures and office visits.

3 Peace of Mind: assuring you of optimal patient care while using the latest cervical cancer detection technologies.

4 HPV Platforms and Testing Options:

a Roche: Analyzes HPV DNA

Detection of High Risk (oncogenic) HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68

Genotyping for 16 and 18 included

HPV primary screening is FDA approved on Roche and available by request.

b Hologic: Analyzes HPV mRNA


Reflex genotyping for 16, 18/45 optional

c Digene: Analyzes HPV DNA

Detection of Low Risk HPV genotypes: 6, 11, 42, 43 and 44 Detection High Risk (oncogenic) HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68

Genotyping not available

d HPV Trifecta: Includes High Risk HPV DNA on Roche, Genotyping for 16/18 on Roche, and Low Risk HPV DNA on Digene. This order option is only available on ThinPrep samples. This order request has entire-office capability only.

PROCEDUREYou can now order a HPV assay every time a patient presents with an ASCUS from a Liquid Based Pap test without having to schedule the patient for a return visit following their initial visit. Following the patient’s diagnostic report, you will receive a HPV Assay request form that can be signed and faxed or mailed back to us. This request must be received within 28 days of original specimen collection.


CYTOLOGY – HPV AND PAP CO-TESTING PRINCIPLEExtensive data shows that HPV nuceleic acid (both DNA and RNA) is a sensitive marker for women at risk of neoplasia and that HPV nuclecic acid testing may be considered as an adjunct to cervical cytology in cancer prevention programs. HPV nucleic acid testing has greater sensitivity than cytology for detecting clinically relevant lesions. The combination of the Pap test and HPV nucleic acid test result in a very sensitive and specific means for assessing a woman’s risk of cervical cancer.

Based on ongoing and completed clinical trials, The American Cancer Society as well as the American College of Obstetrics and Gynecology has endorsed the following recommendations for women over 30:

➤ The combined use of a cervical cytology test and a FDA-approved test for high-risk types of HPV (co-testing).

➤ With this option, the patient would receive both a cervical cytology test and a test that checks for certain high-risk types of the human papillomavirus (HPV) known to cause cancer.

➤ Once women test negative on both tests they could be re-screened with the combined tests no more frequently than every 3 years.

PROCEDURE

1 You can order HPV and Pap Test (co-testing) on patients 25 years or older depending on the platform you choose. The test may be requested by completing the requisition form.

2 The specimen can be collected in either the ThinPrep® or the SurePath™ collection vial. (See sections: Cytology – ThinPrep® Pap Tests™ and Cytology – SurePath™ Pap Tests™ for collection procedure). Alternatively, a second collection in Digene Specimen Transport Media may be collected in addition to the cytologic collection. This

dual collection will result in reduced possibility of a “quantity not sufficient” error.

INTERPRETATION

1 All HPV and Pap requests will be processed for both cytology and HPV regardless of cytologic diagnosis, unless reflex only testing is indicated on the requisition

2 An integrated report with both findings will be issued along with interpretation and management guidelines.

3 New guidelines for management of abnormal cervical screening tests are outlined in detail in the most recent American Society for Colposcopy and Cervical Pathology guidelines. These incorporate the patient’s age, cytologic diagnosis, prior history, genotyping data (when available) and pregnancy status.

COMMENTS

The three platforms available for HPV screening in conjunction with a Pap test are outlined below.

1 Roche: Analyzes HPV DNA, ThinPrep or SurePath


Genotyping for 16 and 18 included

2 Hologic: Analyzes HPV RNA, ThinPrep Only


Reflex genotyping for 16, 18/45 optional

3 Digene: Analyzes HPV DNA, ThinPrep, SurePath, Digene STM

Detection of Low Risk HPV genotypes: 6, 11, 42, 43 and 44

Detection High Risk (oncogenic) HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68

Genotyping not available

CYTOPATHOLOGY – GYNECOLOGY



CYTOLOGY – PAP SMEARS FOR DIETHYLSTILBESTROL (DES) EVALUATION

PURPOSE

Diethylstilbestrol (DES) is a synthetic estrogen that was developed to supplement a woman’s natural estrogen production. Women who have been exposed to DES either directly or when they were in the womb of a mother exposed to DES (DES daughters) have an increased risk in developing clear cell adenocarcinoma (CCA) of the vagina and cervix.

➤ CONVENTIONAL METHODMATERIALS REQUIRED

1 5 frosted end glass slides2 Speculum3 Gauze packs4 Saline5 Spatula and/or other collection device6 Requisition form

PROCEDURE

1 Label slides in pencil with the patient’s name and site of sampling.

2 Complete the requisition form including the patient’s name, date of birth, date of service and billing data. Include the history of DES exposure and all clinical information (LMP, hormone use, prior Pap smear results and biopsy results).

3 Clear cervix of all mucus. Using saline moistened gauze packs, swab the vagina including fornix.

4 Cover the cervix with a gauze pack.

5 Scrape the two lateral walls with the spatula and prepare two smears labeled right and left lateral walls. Spray fix smears immediately.

6 Scrape the entire anterior and posterior walls and prepare each labeled slide appropriately. Spray fix smears immediately.

7 Collect an endocervical smear on a labeled slide and fix smear immediately.

8 Place slides in slide containers and forward them to the laboratory with the completed requisition form.

Note: Particular attention should be paid to the anterior wall of the vagina, as this is the site of most significant lesions associated with DES exposure.

CYTOLOGY – PAP SMEARS FOR DIETHYLSTILBESTROL (DES) EVALUATION

PURPOSE

Diethylstilbestrol (DES) is a synthetic estrogen that was developed to supplement a woman’s natural estrogen production. Women who have been exposed to DES either directly or when they were in the womb of a mother exposed to DES (DES daughters) have an increased risk in developing clear cell adenocarcinoma (CCA) of the vagina and cervix.

➤ LIQUID BASED METHOD

MATERIALS REQUIRED

1 5 liquid based cytology collection vials

2 Speculum

3 Gauze packs.

4 Saline

5 Spatula and/or other collection device

6 Requisition form

PROCEDURE

1 Label the collection vials with the patient’s name and second unique identifier such as date of birth or social security number and site of sampling.

2 Complete the requisition form including patient name, date of birth, date of service and billing data. Include the history of D.E.S. exposure and all clinical information (LMP, hormone use, prior Pap smear and biopsy results).

3 Clear cervix of all mucus. Using saline moistened gauze packs, swab the vagina including fornix.

4 Cover the cervix with a gauze pack.

5 Scrape the two lateral walls with the


spatula or other collection device and transfer into vials labeled right and left lateral walls.

6 Scrape the entire anterior and posterior walls and transfer into appropriately labeled vials.

7 Repeat process for endocervical smear.

8 Forward vials to laboratory with completed requisition form.

Note: Particular attention should be paid to the anterior wall of the vagina, as this is the site of most significant lesions associated with DES exposure.

THE BETHESDA2014 SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES


THE BETHESDA2014 SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSESThe Bethesda System (TBS) for Reporting Cervical/Vaginal Cytologic diagnoses was developed at a National Cancer Institute (NCI) — sponsored workshop in December 1988 to provide uniform diagnostic terminology that would facilitate communication between the laboratory and the clinician. The system was revisited and modified in April 1991, again in September 2001 and most recently in September 2014. The classification used in TBS is not a histogenetic one, but rather a nomenclature designed to facilitate categorization and reporting of cytologic diagnoses. American Pathology Partners adheres to the Bethesda System with minor modifications.

➤ Specimen Type

1 Indicate conventional smear (Pap smear) verses liquid based verses other.

➤ Specimen Adequacy

1 Satisfactory for evaluation (describe presence or absence of endocervical/transformation zone component and any other quality indicators, e.g., partially obscuring blood, inflammation, etc.)

2 Unsatisfactory for evaluation… (specify reason)

a Specimen rejected/not processed (specify reason)

b Specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality because of (specify reason)

➤ General Categorization (optional)

1 Negative for Intraepithelial Lesion or Malignancy

2 Epithelial Cell Abnormality: See Interpretation/Result (specify ‘squamous’ or ‘glandular’ as appropriate)

3 Other: See Interpretation/Result (e.g. endometrial cells in a woman > 45 years of age)

➤ Automated Review

1 If case is examined by an automated device, specify device and result

➤ Ancillary Testing

1 Provides a brief description of the test methods and report the result so that it can be easily understood by the clinician.

➤ Interpretation/Result

NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCYWhen there is no cellular evidence of neoplasia, state this in the “General Categorization” above and/or in the “Interpretation/Result” section of the report, whether or not there are organisms or other non-neoplastic findings).

1 Organisms

a Trichomonas vaginalis

b Fungal organisms morphologically consistent with Candida spp.

c Shift in flora suggestive of bacterial vaginosis

d Bacteria morphologically consistent


with Actinomyces spp.

e Cellular changes consistent with Herpes simplex virus

2 Other Non-Neoplastic Findings (optional to report; list not inclusive)

a Reactive cellular changes associated with:

i Inflammation (includes typical repair)

ii Radiation

iii Intrauterine contraceptive device (IUD)

b Glandular cells status post hysterectomy

c Atrophy

3 Other: Endometrial cells (in a woman > 45 years of age)

a (specify if ‘negative for squamous intraepithelial lesion’)

EPITHELIAL CELL ABNORMALITIES

1 Squamous Cell

a Atypical squamous cells

i Of undetermined significance (ASC-US)

ii Cannot exclude HSIL (ASC-H)

b Low grade squamous intraepithelial lesion (LSIL) encompassing HPV/mild dysplasia/CIN1

c High grade squamous intraepithelial lesion (HSIL) encompassing moderate and severe dysplasia, carcinoma in situ (CIS)/CIN2 and CIN3

i With feature suspicious for invasion (if invasion is suspected)

ii Squamous cell carinoma

2 Glandular Cell

a Atypical – not otherwise specified (NOS)

i Endocervical cells (NOS or specify in comments)

ii Endometrial cells (NOS or specify in comments)

iii Glandular cells (NOS or specify in comments)

b Atypical

i Endocervical cells, favor neoplastic

ii Glandular cells, favor neoplastic

c Endocervical adenocarcinoma in situ

d Adenocarcinoma

i Endocervical

ii Endometrial

iii Extrauterine

iv Not otherwise specified (NOS)

➤ Other Malignant Neoplasms: (specify)

➤ Educational Notes and Suggestions: (optional)

Suggestions should be concise and consistent with clinical follow-up guidelines published by professional organizations (references to relevant publications may be included).


PEDIATRIC/PERINATAL AUTOPSIES

PAP SMEAR COMMENTS – THE BETHESDA2014 SYSTEMSPECIMEN ADEQUACY STATEMENTSPursuant to the Bethesda System 2014, each Pap smear report is given a statement of adequacy. Two categories of adequacy have been defined:

➤ Satisfactory for evaluation describes the presence or absence of endocervical/ transformation zone component and any other quality indicators, e.g., partially obscuring blood, inflammation, etc.)

➤ Unsatisfactory for evaluation…(specify reason)

Note: The quality category of “Satisfactory but limited by…” has been discontinued, however, the report will continue to contain information that might limit the overall quality of the specimen (i.e. partially obscuring inflammation, no endocervical component, etc.). There was a general agreement at the recent American Society for Colposcopy and Cervical Pathology (ASCCP) Clinical Management Meeting that negative satisfactory Paps lacking transformation zone component or exhibit partial obscuring factors should have an annual repeat Pap Test. An early repeat (6-12 months) may be considered in women with insufficient screening history or previous abnormalities. Unsatisfactory Paps should be repeated early (generally 2 -4 months) as such Paps are unreliable for detection of epithelial abnormalities.

DEFINITIONS AND CRITERIA FOR SPECIMEN ADEQUACY”Satisfactory for evaluation” indicates that the specimen has all of the following:

➤ Appropriate labeling and identifying information

➤ Relevant clinical information

➤ Adequate numbers of well-preserved and well-visualized squamous epithelial cells

“Unsatisfactory for evaluation…” is used for a diagnosis if any of the following apply:

➤ Lack of patient identification on the specimen and/or

➤ A technically unacceptable slide defined as: one that is broken and cannot be repaired, cellular material that is inadequately preserved

➤ A scant squamous epithelial component (well-preserved and well-visualized squamous epithelial cells spread over

less than 10% of the slide surface, or for liquid based pap smears, less than 5,000 squamous cells), obscuring blood, inflammation, thick areas, poor fixation, air-drying artifact, contamination, etc. which precludes interpretation of approximately 75% or more of the epithelial cells.

Note: The “Unsatisfactory…” designation indicates that the specimen is unreliable for the detection of cervical epithelial abnormalities. Specimen adequacy is evaluated in all cases. However, any epithelial abnormality is of paramount importance and must be reported regardless of compromised specimen adequacy. If abnormal cells are detected, the specimen is never categorized as ‘Unsatisfactory’ such cases may be considered ‘Satisfactory’, while describing any limiting factors.

PAP TEST INTERPRETATION STATEMENTSPursuant to the Bethesda System 2014, each satisfactory Pap Test report is given an interpretative statement. There are three broad “general” categories:

➤ Negative for Intraepithelial Lesion or Malignancy

➤ Epithelial Cell Abnormality: See Interpretation/Result

➤ Other (i.e., endometrial cells in postmenopausal woman)

NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCYThis term will replace the category of “Within Normal Limits” and other negative terms. The “Benign Cellular Changes” category is now included in this negative category with descriptors included for organisms and reactive changes (i.e. radiation, inflammation, repair, etc.).

EPITHELIAL CELL ABNORMALITY

SQUAMOUS CELL ABNORMALITYThere are modifications to the category “Atypical Squamous Cells of Undetermined Significance” (ASCUS). The new general category is “Atypical Squamous Cells”. The two subcategories are “of undetermined significance”, and “cannot exclude HSIL”. Most experts recommend colposcopy for the “cannot exclude HSIL” subcategory. For the “Atypical Squamous Cells of Undetermined

PAP SMEAR COMMENTS – THE BETHESDA2014 SYSTEM



Significance” subcategory a variety of management options are available including HPV DNA testing, repeat Pap Test or colposcopy. The sub category “Atypical squamous cells, favor reactive” is eliminated. Please see summary in the Clinical Management Guidelines section or visit www.asccp.org.

Note: The terminology for squamous intraepithelial lesions is unchanged (LGSIL, HGSIL).

GLANDULAR CELL ABNORMALITYThe term “Atypical Glandular Cells of Undetermined Significance (AGUS)” is eliminated and replaced by terms such as “Atypical Endocervical Cells” or “Atypical Glandular Cells.” Some cases will be subcategorized as “favor neoplastic” and a few cases may be classified as “Endocervical Adenocarcinoma in situ” if cytologic criteria are met. The category “Atypical Glandular Cells, favor reactive” is eliminated. The “favor reactive” categories were eliminated for both squamous and glandular abnormalities as they proved mixed messages, and some patients did not receive adequate follow-up.

ENDOMETRIAL CELLSThe presence of endometrial glandular cells will be mentioned if the woman is age 45 or older. Given the increasing use of hormonal therapy, the laboratory generally cannot determine whether endometrial cells indicate any abnormal finding, so clinical correlation is suggested. The likelihood of significant endometrial pathology is very low in women younger than age 45; therefore bland endometrial cells will not be reported.

HORMONAL STATUS EVALUATIONThe vaginal/cervical squamous epithelium responds to systemic levels of estrogen by progressively “maturing”. This observation is the basis of the old “Maturation Index (MI)”. The maturation index, however, is not particularly sensitive or specific and has largely been supplanted by serum hormonal assays. Furthermore, the maturation index may only be performed on specimens obtained directly from the lateral vaginal walls (not cervix). Because of the vast majority of Pap Test specimens are from cervical sampling and many are liquid based, a general statement about “estrogen effect” may be given, if indicated, rather than a formal maturation index:

➤ “Estrogen effect consistent with patient age and/or history”

➤ “Low estrogen effect for patient age and/or history”

➤ “High estrogen effect for patient age and/or history”

Formal maturation index readings will continue to be available only on specimens specifically collected from the vaginal walls for the purpose of maturation index calculation.

Please see Appendix 7 for more information on maturation index and other estrogen effect indicators.

INFECTIOUS AGENT COMMENTSUnless cellular atypia or dysplasia is seen, those specimens with clinically significant infectious agents will be classified as “Negative for Intraepithelial Lesion or Malignancy” with a separate listing of any agents present.

The term “Shift in flora suggestive of bacterial vaginosis” will be used for those cases showing bacteria with features of Gardnerella, Mobiluncus, Peptostreptococcus and Streptococcus.

CLINICAL MANAGEMENT GUIDELINESFor detailed recommendations by the American Society for Colposcopy and Cervical Pathology (ASCCP), please visit www.asccp.org.

A summary of guidelines developed at the 2013 ASCCP-Sponsored Consensus Conference follows:

➤ The management of women with atypical squamous cells (ASC) depends on whether the Pap is subcategorized as ASC-US (undetermined significance) or as ASC-H (cannot exclude high grade squamous intraepithelial lesion). Patients with ASC-US should be managed with a program of repeat cytology tests and testing for high-risk types of human papillomavirus (HPV). Testing for HPV is the preferred approach when liquid-based cytology is used. In most instances, patients with ASC-H, low-grade squamous intraepithelial lesion, HSIL, and atypical glandular cells should be referred for immediate colposcopic evaluation.

http://www.asccp.org


PEDIATRICS – PLACENTA SERVICE

PEDIATRICS – PLACENTA SERVICEOVERVIEWThe following pages include information regarding placental consultation to be performed by UniPath and by Eastern Carolina Pathology.

UNIPATHThe placenta service at UniPath is performed by the UniPath, PC Pediatric and Perinatal Pathologists at Presbyterian/St. Luke’s Medical Center/Rocky Mountain Hospital for Children. A clinical history worksheet (to be completed by the obstetrician/pediatrician requesting examination) and a placental examination requisition are required for this service. These will provide the pathologist with the information needed to answer important clinical questions. Please also include billing information (billing face sheet) for the patient or mother. All costs associated with transport of specimens will be incurred by the requesting facility. The patient or insurance will be billed for the examination of the placenta and any additional testing (i.e. cytogenetic studies, molecular testing, or other important studies).

It is very important that the paperwork be filled out completely and include contact information for the requesting clinician. Copies of additional medical records or other such information are helpful and should be included if available.

Placentas should be kept fresh in a sealed specimen container and refrigerated until delivery to our institution. Please keep the placenta “fresh” (it is very important not to put the placenta in formalin), to allow for the most complete examination and allow for additional testing if needed. The placenta should have appropriate identification, sealed in a leak proof container, be double bagged in biohazard appropriate wrapping, and appropriately labeled as “biohazard”.

UniPath deliveries should be clearly addressed to:

UniPath Consult Service – Pediatric Pathology

Presbyterian/St. Luke’s Medical Center – Department of Pathology

1719 East 19th Avenue, Building C, 6th Floor East, Denver, CO 80218

Delivery will only be accepted between the hours of 8:30 a.m. and 4:00 p.m., Monday through Friday. Outside of these hours, the placenta can be refrigerated and sent the following business day. Delivery can be arranged through courier service or FedEx deliveries are accepted.

Once the specimen is received and examination is complete, a final report will be released to the requesting physician and institution of origin. Tissue disposition will occur at our facility unless return is specifically requested. If the placenta is to be returned, cost of transport will be the responsibility of the requesting facility.

Please call UniPath’s Client Relations for any questions regarding this service: 303.512.2210

EASTERN CAROLINA PATHOLOGYEastern Carolina Pathology offers placental consult services for local hospitals. All necessary paperwork is provided and filled out by the requesting hospital and transport of the specimen is facilitated by ECP courier staff.


PEDIATRIC/PERINATAL AUTOPSIESPlacentas should be kept fresh in a sealed specimen container and refrigerated until delivery to our facility. Please keep the placenta “fresh” (it is very important not to put the placenta in formalin), to allow for the most complete examination and allow for additional testing if needed. The placenta should have appropriate identification, sealed in a leak proof container, be double bagged in biohazard appropriate wrapping, and appropriately labeled as “biohazard”.

Once the specimen is received and examination is complete, a final report will be released to the requesting physician and institution of origin. Tissue disposition will occur at our facility unless return is specifically requested. If the placenta is to be returned, cost of transport will be the responsibility of the requesting facility.

Please call ECP’s Client Relations for any questions regarding this service: 252.234.2841


UNIPATH OVERVIEW The following pages include information regarding autopsies to be performed by UniPath. Autopsies requested at UniPath will be performed by Unipath, PC Pediatric and Perinatal Pathologists at Presbyterian/St. Luke’s Medical Center/Rocky Mountain Hospital for Children . An autopsy permit for UniPath, PC (at PSLMC/RHMC), a clinical history worksheet (to be completed by the obstetrician/pediatrician requesting examination), and a placental examination requisition are required.

All costs associated with transport of specimens (body and placenta) and autopsy fees will be incurred by the requesting facility. The patient or insurance will be billed for the examination of the placenta and any additional testing (i.e. cytogenetic studies, molecular testing, or other important studies). Billing information (billing face sheet) for the patient or mother (perinatal cases) should be included.

It is very important that the paperwork be filled out completely and signed prior to transport of the body. Autopsy permits are required for all post mortem examinations, including those sent for external examinations only and fetuses of any gestational age. The permit must be signed by the next of kin (mother or father) and witnessed. Phone consent is permitted but requires signature of two witnesses. Please call our office (303.839.6851), to inform us of a pending autopsy prior to transport of the body. You can fax paperwork to 303.869.1786 and enclose the original paperwork with the body.

Please do not include original paperwork that your facility may need to keep such as the death certificate. Copies of additional medical records or other such information are helpful and should be included if available.

Please make sure that the container in which the body and “fresh” placenta (it is very important not to put the placenta in formalin) are clearly addressed to:




Delivery will only be accepted between the hours of 8:30 a.m. and 4:00 p.m., Monday through Friday. Outside of these hours, the body can be refrigerated and sent the following business day.

Bodies should be transferred in a timely manner after delivery/death. The body should have appropriate identification, be double bagged in biohazard appropriate wrapping, and sealed in a leak proof container and refrigerated until delivery to our institution.

Once we receive the body and the autopsy is complete, our secretarial staff will call the referring facility. Please make arrangements to have the body picked up by your designated courier service and returned back to your facility for either disposition or funeral as requested


by the family. Again, all costs associated with transport and autopsy fees will be incurred by the requesting facility.

PEDIATRIC CONSULT SERVICE AUTOPSY CHECKLIST

DELIVERY OF BODY & SPECIMENS

➤ Referring department must call UniPath at P/SL MC to inform service of pending autopsy and to determine adequate staffing for receipt of body and performance of examination.

• Arrangements to be made with P/SL MS administrative personnel (TBD @ 303.839.6851).

• Bodies and specimens will only be accepted between the hours of 8:30 a.m. and 4:00 p.m.

➤ Bodies should be appropriately packaged and transferred in a timely manner after delivery/death.

• The body should be double bagged in biohazard appropriate wrapping, and sealed in a leak proof container and appropriately labeled as “biohazard”.

• Placentas should be kept fresh in a sealed specimen container and refrigerated until delivery.

• Bodies and placentas need to be appropriately labeled with patient identifiers.

➤ All specimens must be appropriately addressed to:




Phone: 303.839.6851

Fax: 303.869.1786

Pediatric/Perinatal Autopsies, Cont.


Home Manual:

Hospital Services-General

Established: 5.18.12

Author: Dr. Mengshol Revised: 06/18/14 (AJF) Procedure: APP-UniPath Consult Autopsy Service Protocol Responsible Parties: Hospital Sites Additional Sites:

Purpose: To clarify receipt and release of bodies sent to Presbyterian/St. Luke’s Medical Center (P/SLMC).

Procedure: I. Delivery of Body & Specimens

A. Departments referring cases to P/SL will call the administrative staff at P/SL (303-839-6851) to alert the department of a pending autopsy and to determine arrangements. 1. If the case is originating from another APP-Unipath hospital site, prior to receipt at P/SL, the

placenta and fetus will be accessioned into the Cortex and Meditech systems with the appropriate autopsy and surgical pathology patient identifier numbers. a. Cassettes and labels with unique barcodes will be generated through the Vantage

system and sent with the case to P/SL. b. Placental tissue will be triaged and held in RPMI at the originating facility for possible

chromosome analysis on all autopsy cases. The pathologist reading the case will contact the originating facility to indicate if the tissue is to be sent out for testing.

2. A copy of all requisitions and clinical information received (including the autopsy permit and insurance face sheet) is sent with the case. a. If the case is originating from an outside (non-APP-Unipath facility), P/SL will send the

originating facility the Autopsy Information Packet (see attached). This packet includes: billing information, specimen drop off and release of remains information, permits for the post mortem evaluation, and post mortem questionnaire and placental examination requests to ensure proper consent and history is obtained prior to the autopsy and placental examination being performed at P/SL.

3. The originating facility is to maintain written documentation that a body was transported to P/SL for autopsy. This record will be updated when the body is returned, following autopsy.

B. P/SL is responsible for adequately staffing the department for receipt of the body and performance of autopsy examination. 1. Bodies and specimens will only be accepted between the hours of 0830 and 1600 2. All after hours (due for receipt after 1600) and weekend cases must be held for shipment

until after 0830 on the following business day. In these cases, the tissue should be refrigerated and stored fresh (not in formalin) until arrangements are made the following business day.

C. Bodies should be appropriately packaged and transferred in a timely manner after delivery/death. 1. The body should be double bagged in biohazard appropriate wrapping, sealed in a leak proof

container, and appropriately labeled as “Biohazard”. 2. Placentas should be kept fresh in a sealed specimen container and refrigerated until delivery

to P/SL. 3. All specimens must be appropriately labeled with at least two, unique patient identifiers. 4. Larger fetal demises may sometimes arrive in large, coffin-style cases, which do not fit in the

usual courier coolers and should be handled as follows: a. Remove the body from the coffin case, and completely wrap/cover. b. Place the body, placenta, and completed paperwork into a large, rolling cooler. c. Contact the Courier Supervisor at UCL to alert the couriers that there will be a large

cooler for transport to P/SL. D. All specimens should be addressed to:

APP-UniPath Consult Service-Pediatric Pathology Service Presbyterian St. Lukes Medical Center 1719 E. 19th Ave, Building 6C, Denver, CO 80218

Phone: (303)-839-6851 | Fax: (303)-869-1786 E. The referring departments are responsible for transporting cases to P/SL. At the time of delivery,

the delivering personnel will be escorted to the morgue (building 6C). F. Cases will be entered into the autopsy log with all appropriate information, including (but not

limited to): date and time of receipt, referring institution, the full name (signature and printed) and contact information for delivering personnel to include company or department affiliation, and the initials of APP-UniPath escort.

G. All specimens must be appropriately labeled with patient identifiers and accompanied by necessary paperwork, including a signed autopsy consent form and pertinent clinical history. 1. The APP-UniPath Consent Form is preferred; any outside consent forms must indicate that a

pediatric pathologist will perform the autopsy at an APP-UniPath facility. 2. The APP-UniPath post mortem pediatric questionnaire and placental examination requisition

is preferred with any pertinent additional clinical history to be included as available. 3. A billing information form (face sheet) must be included for billing of placenta and extra

studies as requested/needed. 4. Cases without appropriate paperwork or identification, or cases inappropriately packaged or

addressed will not be accepted. 5. Paperwork may be faxed to the APP-UniPath Autopsy Consult Service (303-869-1786) prior to

deliver to ensure appropriate consent has been obtained.

II. Release of Remains A. APP-UniPath personnel will contact the referring department when autopsy examination is

complete. 1. Bodies will be released by APP-UniPath personnel to indicated courier between 0830 and

1500 Monday-Friday. B. It is the responsibility of the referring institution to arrange pick-up and return of the body to any

outside department or facility. APP-UniPath will not be responsible for release to mortuaries or families.

C. All placental tissue will be held at P/SL and disposed of per policy for surgical specimens, unless a request is received to return the tissue to its institution of origin.

III. Reporting of Results

A. Preliminary autopsy diagnoses are to be released to the referring department within two business days.

B. The final diagnosis, including complete report and results of ancillary testing, is to follow within 60 business days.

C. Reports may be released directly to families with a signed medical release. D. Reports may be released directly to the clinician of record or to another clinician (as designated), if

a signed medical release is provided. IV. Record and Block Archival

A. Copies of the autopsy consent forms for each case, as well as copies of all associated paperwork for the case, are maintained in a case file. The pathologist assigned the case keeps this file until the case has been signed out. After sign-out the case file is stored in the PSL Pathology office (6C) autopsy storage area.

B. Slides and blocks will be stored per the APP Corporate Policy for Retention and Destruction-Technical.

Approval of Procedure: Medical Director Signature/Date:


➤ All specimens must be appropriately labeled with patient identifiers and accompanied by necessary paperwork to include signed autopsy consent form and clinical history.

• UniPath Consent Form preferred; outside consent forms must indicate that a pediatric pathologist will perform the autopsy at a UniPath facility.

• UniPath post mortem pediatric questionnaire and placental examination requisition preferred; additional clinical history to be included as available.

• Billing information (face sheet) for billing of placenta and extra studies as requested/needed.

• Cases without appropriate paperwork or identification will not be accepted.

• Paperwork may be faxed beforehand to UniPath Autopsy Consult Service at 303.869.1786 to ensure appropriate consent is obtained.

• ***All after hours (4:00 p.m.) and weekend cases must be held for shipment until after 8:30 a.m. on the next business day***

• In this case, body and placenta should be refrigerated and stored fresh (not in formalin) until arrangements are made the following business day.

RELEASE OF REMAINS

➤ UniPath personnel will contact outside referring department when examination is complete.

➤ Bodies will be released by UniPath personnel to indicated courier between 8:30 a.m. and 3:00 p.m. Monday – Friday.

➤ Referring institution to arrange pick-up and return of body to outside department (UniPath will not be responsible for release to mortuaries or families) between 8:30 a.m. and 3:00 p.m. Monday – Friday.

➤ Placental tissue will be held at P/SL MC and disposed of per UniPath policy for surgical

specimens, unless request received to return to institution of origin.

REPORTING RESULTS

➤ Preliminary Autopsy Diagnosis to be released within 2 business days to referring department.

➤ Final Autopsy Diagnosis, including complete report and results of ancillary testing, to follow within 60 business days.

➤ Reports may be released directly to families with signed medical release.

➤ Reports may be released directly to clinician of record or to other clinician if signed medical release is provided.


PERMIT FOR PEDIATRIC POST MORTEM EXAMINATION

PEDIATRIC/PERINATAL AUTOPSIES, Cont.



POST-MORTEM QUESTIONNAIRE

APPENDIX 1

APPENDIX 1

APPENDIX


APPENDIX 1: IMMUNOPATHOLOGY LIBRARY OF ANTIBODIES

APPENDIX 2: IMMUNOHISTOCHEMISTRY/MOLECULAR PROGNOSTIC MARKERS

APPENDIX 3: SPECIAL STAINS

APPENDIX 4: HEMATOPATHOLOGY DIAGNOSTIC PROFILES

APPENDIX 5: AVAILABLE MOLECULAR TESTS

APPENDIX 6: APERIO SCAN SCOPE AT

APPENDIX 7: MATURATION INDEX AND OTHER ESTROGEN EFFECT INDICATORS

APPENDIX 8: ADDITIONAL FORMS1 Supply Order Form

2 Advanced Beneficiary Notice of Noncoverage (ABN)

3 Add-on Request Form

4 Requisitions

APPENDIX 9: REFERENCE LABORATORY INFORMATION1 Counsyl

2 Interpace Diagnostics

3 MDxHealth

4 NeoDiagnostix

5 Progenity

6 Sequenom

7 University of Colorado – DIF

APPENDIX 10: LABORATORY TEST DIRECTORY

APPENDIX CONTENTS

APPENDIX CONTENTS


APPENDIX 1: IMMUNOPATHOLOGY LIBRARY OF ANTIBODIESAP2 and its subsidiaries utilize a large library of primarily monoclonal antibodies. These antibodies are utilized individually and in panels to assist the pathologist in diagnosing cases and to aid the clinician in further treating their patients.

AdenovirusArginase -1

AFPALK 1B72.3Bcl-2Bcl-6

BerEP4Beta-Catenin

BOB.1BRST-2 (GCFP-15)

c-MYCCA 19-9CA 125

CalcitaninCalponin

CD1aCD2CD3CD4CD5CD7CD8CD10CD15CD19CD20CD21CD23CD30CD31CD34CD38CD43CD44

CD45 (LCA)CD56 Lymphoid

NeoplasmCD56 Non – lymph

CD57CD61

CD68CD79aCD99CD117CD138CD163CDX-2

CEA-monoCEA-poly

Chromogranin ACK AE1/AE3

CK AE1/AE3 Sentinel Node

CK CocktailCK – HMW

CK – LMW (Cam 5.2/CK8)CK OSCAR

CK 5/6CK 7CK 17CK 19CK 20CMV

Cyclin D1D2-40

DesminDOG-1

E-CadherinEMAER

Factor 13aGATA 3 GFAP

Glycophorin AGlypican-3

Granzyme BH. pyloriHBME-1

hCGHep-Par-1

HHV-8

HMB-45HSV (Herpes I&II)

IgGIgG4

Inhibin-aKappaKi-67

LambdaMIG9 (S100P)Mammaglobin

MelanAMelan A Sentinel Node

MITFMoc-31

MSAMUM-1

Myeloperoxidase (MPO)MyogeninNapsin A

NSEOCT 2

OCT 3/4p16p53p63p120

P501s (PSAP)P504sPD-1

ParvovirusPAX-5PAX-8PLAP

PRProcaollagen

PSAPTHRCC

S-100 polySMA

SMMHC

SmoothelinSOX-10Strep AStrep B

Stromelysin-3Synaptophysin

TdTThyroglobulin

TIA-1TRAcP (TRAP)

Treponema palidumTLE1

TRAcP(TRAP)Tryptase

TTF-1Villin

VimentinVZVWT-1

DUAL COLOR STAINSBcl-2/PAX 5

Breast Marker Cocktail (Triple Breast)

Kappa/LambdaPIN 4 (Prostate Cocktail)

SMACK

ISH PROBESEBERHPV

KappaLambda

KIDNEYIF Panel:

FITC Antibodies: IgA, IgG, IgM, C3, Clq, Kappa,

LambdaC4d

Polyomavirus

APPENDIX 1


APPENDIX 1

APPENDIX 1: IMMUNOPATHOLOGY LIBRARY OF ANTIBODIES, Cont.


HEMATOPATHOLOGY PANELS

DLBCL (DIFFUSES LARGE B CELL LYMPHOMA)bcl-2bcl-6CD3CD5CD10CD20CD30Ki-67

MUM-1c-MYCPAX-5

EBER (ISH)

CHL (CLASSICAL HODGKIN’S LYMPHOMA)CD3CD15CD20CD30CD45CD163PAX-5

EBER (ISH)

IMF (MYCOSIS FUNGOIDES)CD2CD3CD4CD5CD7CD8CD20CD30

B-CELL (BASIC B-CELL LYMPHOMA)bcl-2bcl-6CD3CD5CD10CD20CD21CD23

Cyclin D1Ki-67PAX-5

LN (LYMPH NODE PANEL)bcl-2CD3CD20CD21Ki-67

MZ (MARGINAL ZONE ADD-ON)CD43Kappa

Lambdabcl-2/PAX-5 Dual Stain

T-CELL LYMPHOMAALK 1bcl-6CD2CD3CD4CD5CD7CD8CD10CD21CD23CD30

CD56-LymphGranzyme B

Ki-67PD-1TdT

TIA-1EBER (ISH)

NLPHL VS. T.HRDLBLBOB.1CD3CD15CD20CD21CD30CD45

Cyclin D1Ki-67OCT 2PAX-5

EBER (ISH)


APPENDIX 1

APPENDIX 1: IMMUNOPATHOLOGY LIBRARY OF ANTIBODIES, Cont.

PROOF PROOF PROOF PROOF PROOF
















X STAIN CPT CODE X STAIN CPT CODE X STAIN CPT CODEAFB 88312 CD5 88342 MELAN-A 88342ALCIAN BLUE 88313 CD15 88342 MICROSATELITE TESTINGCOLLOIDAL IRON 88313 CD20 88342 MLH-1 88342CONGO RED 88313 CD30 (Ki1) 88342 MSH-2 88342CRYSTAL VIOLET 88313 CD31 88342 MSH-6 88342ELASTIC 88313 CD34 88342 PMS-2 88342FONTANA MASON 88313 CD43 88342 MITF 88342GIEMSA (TISSUE DQ) 88313 CD45RO 88342 NAPSIN A 88342GIEMSA (BM) 88313 CD68 88342 PAX 8 88342GMS/FUNGUS 88312 CDX2 88342 P-16 88342GMS/PCP 88312 CEA 88342 P-40 88342GRAM 88312 CHROMOGRANIN 88342 P-53 88342IRON 88313 CKAE1/AE3 (PAN) 88342 P-57 88342MUCICARMINE 88313 CK5 (CK5/6) 88342 P504/P63 (PIN Cocktail) 88342OIL RED O 88313 CK7 88342 P63 88342PAS/H 88313 CK20 88342 PROGESTERONE 88342PAS/FUNGUS 88312 CK34 betaE12 88342 PSA 88342PAS W/ & W/0 DIAST 88313 CMV 88342 PSAP 88342RETIC 88313 CYCLIN D1 88342 S-100 88342TRICHROME 88313 DESMIN 88342 SOX 10 88342

E-CADHERIN 88342 SYNAPTOPHYSIN 88342EMA 88342 THYROGLOBULIN 88342

IHC ESTROGEN 88342 TTF-1 88342ACTIN (MUSCLE SPEC) 88342 FACTOR 8 88342 VIMENTIN 88342ACTIN (SMOOTH MSCL) 88342 FACTOR 13a 88342BCL-2 88342 GATA 3 88342BCL-6 88342 GCDFP-15 88342Ber-EP4 88342 H PYLORI 88342CALRETININ 88342 HMB-45 88342CD10 88342 HSV I & II 88342CD1a 88342 Ki-67 88342CD138 88342 LCA (CD45) 88342CD3 88342 MAMMAGLOBIN 88342

2013 Ponce de Leon Ave.West Palm Beach, FL 33407561.659.0770561.659.0413 Fax561.693.4753 Billing1.800.749.6595http://www.pbpdx.com

HISTOLOGY SPECIAL STAIN REQUISITIONFOR LAB PURPOSES ONLY

CYTO Accession # __________________________

TISSUE Accession # _________________________

DATE/TIME rec’d ____________________________

PBP CLIA# 10D0286650PBP CAP# 1515301

STAT ROUTINE ICD-10 REQUIRED: ____________________

Name of Referring Physician: ______________________________________________________________________________Patient Last Name:______________________________ First: __________________________ MI: ______ SEX: M FDate of Birth: _________________ SS# ________________________________ Collection Date: ________________________Patient Address: ___________________________________________________ Patient Phone #: _______________________City: _________________________________ State: _______Zip: ___________Patient Work #: ________________________

COPY OF INSURANCE CARD (REQUIRED) FRONT AND BACK Please attach a current patient face sheet.

SPECIMEN # __________________ BLOCK # ________ ORDERING PHYSICIAN _________________________

______Levels X3 ______Serials X3 or 5 ______Recuts ______Additional Tissue Hospital _____________

Please provide ABN when applicable DATE ORDERED:____________________________

DATE COMPLETED: _________________________ TECHNOLOGIST: __________________________Client – Pink Copy Lab – Yellow Copy

APPENDIX 2


APPENDIX 2

APPENDIX 2: IMMUNOHISTOCHEMISTRY/MOLECULAR

PROGNOSTIC MARKERS

APPENDIX 2


APPENDIX 3: SPECIAL STAINSAP2 and its subsidiaries utilize a variety of special stains to assist the pathologist with either the diagnosis or confirmation of a diagnosis.

SPECIAL STAINS AVAILABLEAcid Fast Bacteria .............................................................................................................Ziehl-Nielson AFBAcid mucosubstance and neutral polysaccharides .........................................................................AB/PASAmyloid .........................................................................................................................................Congo RedAmyloid………………………………………………………………………………………… ......... Crystal VioletBacteria .........................................................................................................................................Gram stainBasement Membrane .......................................................................................................................... JonesBile…… .......................................................................................................................... Hall’s Bilirubin StainCalcium…………………………………………………………………………………… ...............…….VonKossaCarbohydrates ................................................................................................................. Alcian Blue pH 2.5 Connective Tissue ......................................................................................Masson’s Trichrome ConnectiveCopper ........................................................................................................................................... RhodanineElastic .......................................................................................................................Verhoeff’s Elastic (VVG)Fat…… ............................................................................................................................................. Oil Red OFungus ...............................................................................................Grocott’s Methenamine Silver (GMS)Fungus ............................................................................................Periodic Acid-Schiff for Fungus (PAS/F)Glycogen ................................................................................................................. Period Acid Schiff (PAS)Diatase Digestion for Glycogen Removal ………….............………………………………PAS with DiataseIron… ........................................................................................................................................ Gomori’s IronColloidal Iron ............................................................................................................Muller’s Colloidial IronMelanin ............................................................................................................................... Fontana MassonMelanin removal .................................................................................................................. Melanin BleachMast Cells ............................................................................................................................................GiemsaMast Cells……… ............……………………………………………………………………………Toluidine BlueModified Acid Fast Bacteria/Nocardia .................................................................................................. Fite’s Mucin ...........................................................................................................................Mayer’s Mucicarmine Mucin Digestion ....................................................................................................Hyaluronidase DigestionMuscle Striations…………………………………………………………………………………… ..........….PTAHMyelin .............................................................................................................................Luxol Fast Blue/PASMyelin (Brain)………………………………………………………………………………… ..........…….LFB/PASNeurofibrillary and senile plaques (Alzheimer’s disease) ................................................... BielschowskyReticulin Fibers ....................................................................................................................................... ReticSpirochetes .............................................................................................................................Warthin-StarryTissue/Muscle ........................................................................................................................... PentachromeUric Acid ................................................................................................................................. Uric Acid Stain

APPENDIX 3


APPENDIX 4: HEMATOPATHOLOGY DIAGNOSTIC PROFILES

➤ ALL – Acute Lymphoid Leukemia

➤ ALPS – Autoimmune Lymphoproliferative Syndrome

➤ AML/Myeloid – Acute Myeloid Leukemia

➤ CLL/Lymphoma – Chronic Lymphocytic Leukemia

➤ MPN – Myeloproliferative Neoplasm

➤ Myeloma

➤ PNH (peripheral blood only) – Paroxysmal Nocturnal Hemoglobinuria

APPENDIX 4


APPENDIX 5: AVAILABLE MOLECULAR TESTS

ThinPrepTM SurePathTM UniSwabVaginal/

Anorectal Culture Swab

UPT Urine

Self Collection

DeviceESwab

Actinomyces israelii F F

Atopobium vaginae F F F

Bacteroides fragilis F F F

BVAB2 F F F

Candida albicans F F F

Candida glabrata F F F

Candida kefyr F F F

Candida krusei F F F

Candida parapsilosis F F F

Candida tropicalis F F F

Chlamydia trachomatis F F F F, M F, M

Cytomegalovirus (CMV) F F

Gardnerella vaginalis F F F

Group A Strep with C/G F, M

Eggerthella species F F F

Haemophilus ducreyi F F

Herpes Simplex Virus (HSV-1) F F F, M

Herpes Simplex Virus (HSV-2) F F F, M

HPV (Low Risk, High Risk, and Genotyping) F F

Lactobacillus crispatus F F F

Lactobacillus gasseri F F F

Lactobacillus jensenii F F F

Lymphogranuloma venereum (LGV) F F

Megasphaera species type 1 F F F

Megasphaera species type 2 F F F

Mobiluncus mulieris F F F

Mobiluncus curtisii F F F

Molluscum contagiosum virus F F

M. genitalium F F F F, M

M. hominis F F F

Neisseria gonorrhoeae F F F F, M F, M

Treponema pallidum (syphilis) F F F, M

Trichomonas vaginalis F F F F, M

Ureaplasma urealyticum F F F F, M

Vaginal Group B Strep FVaginal Group B Strep Antibiotic Resistance

F

Varicella Zoster Virus F, M

F – Female M - Male

APPENDIX 5APPENDIX 6

APPENDIX 5


APPENDIX 5

APPENDIX 6: APERIO SCAN SCOPE ATUniPath now offers quantitate Estrogen, Progesterone, and Ki-67 (proliferative marker) using the Aperio Scan Scope AT. Aperio is a novel hardware and software imaging system incorporating automated microscopy and an advanced color recognition technology.

Estrogen and Progesterone Receptors result of < 9% stained nuclei is unfavorable and > 19%stained cells is favorable*.

The Ki-67 (proliferative marker) result of < 19% is prognostically favorable.

* Reference for ER/PR scoring scheme: JM Harvey, GM Clark, DC Allred. Estrogen receptor status by immunohistochemistry is superior to the ligand binding-assay for predicting response to adjuvant endocrine therapy in breast cancer. J. Clinical Oncology 17: 1474-1481, 1999.

APPENDIX 6 BACTERIAL VAGINOSIS PANEL Mobliuncus mulieris Mobliuncus curtisii Gardnerella vaginalis Atopobium vaginae Mycoplasma genitalium Mycoplasma hominis

CANDIDA VAGINITIS PANEL Candida albicans Candida glabrata Candida parapsilosis Candida tropicalis

LACTOBACILLUS PANEL Lactobacillus crispatus Lactobacillus gasseri Lactobacillus jensenii

LEUKORRHEA PANEL Neisseria gonorrhoeae Chlamydia trachomatis Trichomonas vaginalis

PREGNANCY PANEL Chlamydia trachomatis Neisseria gonorrhoeae Ureaplasma urealyticum Mycoplasma genitalium Mycoplasma hominis Trichomonas vaginalis Gardnerella vaginalis Atopobium vaginae Mobliuncus mulieris Mobliuncus curtisii

VAGINITIS PANEL Candida albicans Trichomonas vaginalis Gardnerella vaginalis

GENITAL ULCER DISEASE PANEL H. ducreyi HSV-1 HSV-2 T. pallidum

Appendix 5, Cont.

AVAILABLE MOLECULAR PANELS FOR GYNECOLOGICAL TESTING

APPENDIX 6


APPENDIX 7: MATURATION INDEX AND OTHER ESTROGEN EFFECT INDICATORSThe relationship between hormonal cycles and maturation of squamous cells of the vagina was first noted by Rameriz, and later by Papanicolaou in the 1920’s. Papanicolaou’s basic research was on the hormonal cycles of the female genital tract and he only incidentally discovered the usefulness of exfoliative cytology in detection of cervical cancer. The ability to perform a Maturation Index (MI) is based on the assumption that sex hormones (estrogen, progesterone and androgens) induce maturation sequences in squamous cells that can be detected by cytological examination.

The MI is a ratio obtained by performing a random cell count of the three major cell types shed from the squamous epithelium – parabasal cells, intermediate cells and superficial cells. This count is then given as a percentage (MI=% parabasals, % intermediate, % superficial). Parabasal cells show the least maturity, therefore indicating no estrogen or progesterone stimulation. Intermediate cells show partial maturation and are stimulated by progesterone. Superficial cells show the most maturity, indicating estrogen stimulation.

MI’s vary from patient to patient, and day to day in an individual patient. The only two absolute cell patterns are:

1 Predominance of parabasal cells indicating absence of estrogen stimulation.

2 Predominance of superficial cells indicating estrogen stimulation.

3 Intermediate cell patterns have minimal usefulness.

A meaningful MI must be taken as a gentle scrape along the lateral wall of the upper vagina at the level of the cervix. The cells from this area accurately reflect the hormonal balance present at a given time. It should be free of inflammation and endocervical contamination, which can falsely elevate the MI. Many factors can influence the accuracy of the MI including endocervical cell contamination, presence

of microorganisms or large numbers of inflammatory cells. Patient history, especially menstrual status, and information about medications that the patient is taking at the time of the Pap smear is very important in providing an accurate hormonal evaluation.

Because gynecologic cytology specimens are almost invariably obtained from the cervix (in those patients with cervices) a formal maturation index is not appropriate and will not be performed on those specimens. However, valuable information can be obtained by evaluating the overall degree of maturation and correlating it with the patient’s age and history and expressed as an “Estrogen Effect” statement.

➤ Estrogen effect consistent with Patient age/history.

➤ Estrogen effect high for Patient age/history.

➤ Estrogen effect low for Patient age/history.

Formal Maturation Index will only be performed upon specific request and on specimens collected from the vaginal wall not showing confounding inflammation, atypical cells or endocervical contamination.

APPENDIX 7APPENDIX 8

APPENDIX 7


APPENDIX 7

APPENDIX 8: ADDITIONAL FORMS1. SUPPLY ORDER FORMS

UniPath ● 6116 East Warren Avenue, Denver , CO 80222 ● Supplies - 303.512.2216 ● 866.864.7284 ● Fax: 303.512.2246

CLINICIAN INFORMATION Practice/Clinician: ____________________________ Contact Name: ___________________________ Address: ___________________________________ Contact Number: _________________________

City/State/Zip:______________________________ Date Ordered: ___________________________

REQUISITIONS (Please indicate quantity)

Dermatopathology: ______ Surgical/Tissue: ______ Head & Neck: ______ Hematopathology ______

Women’s Health: ______ GI: ______ Urology: ______ Cytology/Histology ______ Breast: ______

PREMIUM TEST KITS (Please indicate quantity)

Prostate: ______ FNA: ______ FNA Bilateral: ______

Bone Marrow: ______ Peripheral Blood: ______ Urine/UroVysion: ______

SPECIMEN HANDLING (Please indicate quantity)

Specimen Bags (100/pk): ______ FedEx Bags w/Shipping Boxes: ______ GBS Cylinders: _______

FORMALIN CONTAINERS (Please indicate quantity)

20 mL (24/box): ______ 40 mL (24/box): ______ 60 mL (24/box): ______ 120 mL (24/box): ______

EMPTY SPECIMEN CONTAINERS (Please indicate quantity) 4 oz: _____ 16 oz: _____ 32 oz: ______ 83 oz: ______ 172 oz: ______

FNA AND BONE MARROW SUPPLIES (Please indicate quantity) Green top (100/tray): ______ RPMI: ______ Frosted Slides: ______

Puple Top (100/tray) ______ Cytolyt -30 ml (20/tray): ______ Cardboard-2 Slide Holders: ______

B+ Fixative 20 ml: ______ Plastic – 5 Slide Holders: ______

MOLECULAR TESTING (Please indicate quantity)

UniSwab (25/pk): ______ ESwab (10/pk): ______

GBS by UniPath (10/pk): ______ BD Urine UPT (10/pk): ______ BD Self-Collection Device (10/pk): ______

PAP TESTING (Please select method and indicate quantity) SUREPATH THINPREP

Fixative Vials (25/tray): ______ Fixative Vials (25/tray): ______

Blue CytoBrooms (25/bag): ______ Purple CytoBrooms (papettes) (25/bag): ______

CytoBrooms and Clear Spatulas* (25/bag): ______ CytoBrooms and Clear Spatulas* (25/bag): ______ *Packaged together and cannot be ordered separately *Packaged together and cannot be ordered separately

White Handle CytoBrushes Only (100/bag): ______ White CytoBrushes Only (100/bag): ______

CombiBrooms (25/bag): ______

LOGISTICS USE ONLY:

Supply Order Form Revised 1.6.17

APPENDIX 8

APPENDIX 8


CLINICIAN INFORMATION Practice/Clinician: ____________________________ Contact Name: ___________________________ Address: ___________________________________ Contact Number: _________________________

City/State/Zip:______________________________ Date Ordered: ___________________________ REQUISITIONS (Please indicate quantity)

Dermatopathology:______ Surgical/Tissue: ______ Head & Neck: ______ Breast: ______

Women’s Health: ______ GI: ______ Urology: ______ Cytology/Histology: ______

PREMIUM TEST KITS (Please indicate quantity)

Interpace Dx: ______ Prostate: ______ FNA: ______ FNA Bilateral: ______ Urine/UroVysion: ______

SPECIMEN HANDLING (Please indicate quantity) Specimen Bags (100/package): ______ FedEx Bags w/Shipping Boxes: ______

FORMALIN CONTAINERS (Please indicate quantity)

20 mL: ______ 60 mL: ______ 120 mL: ______

EMPTY SPECIMEN CONTAINERS (Please indicate quantity) 8oz: _____ 16oz: ______ 32oz: ______ 86oz:______ 172oz: ______ 10% formalin(gallon):___ (for use with empty containers)

FNA AND BONE MARROW SUPPLIES (Please indicate quantity) Bone Marrow Kits: ______ Frosted End (72/box): ______ RPMI: _______

Peripheral Blood Kits: ______ Cytolyt Fixative: ______ Red Top Alcohol Fixative (25 each): ______

MOLECULAR TESTING (Please indicate quantity)

UniSwab - Pack of 25: ______ Pack of 10: ______ Pack of 5: ______

GBS by UniPath- Pack of 10: ______ Pack of 20: ______ BD Urine UPT (10/pack): ______

ESwab: ______ BD Self-Collection Device: ______

PAP TESTING (Please select method and indicate quantity) SUREPATH THINPREP

Fixative Vials (25/tray): ______ Fixative Vials (25/tray): ______

Blue CytoBrooms (25/bag): ______ Purple CytoBrooms (25/bag): ______ (papettes)

CytoBrooms and Clear Spatulas* (25 each/bag): ______ CytoBrooms and Clear Spatulas* (25 each/bag): ______ *Packaged together and cannot be ordered separately *Packaged together and cannot be ordered separately

White Handle CytoBrushes Only (100/bag): ______ White CytoBrushes Only (100/bag): ______

CombiBrooms (25/bag): ______

LOGISTICS USE ONLY:

Eastern Carolina Pathology + 2693-B Forest Hills Road, Wilson, NC 27893 + 252.234.2841 + 866.572.8452 + Fax: 252.234.9270 + www.ecpdx.com

Supply Order Form Revised 1.6.17

Appendix 8: Additional Forms, Cont.

APPENDIX 8


2. ADVANCE BENEFICIARY NOTICE OF NONCOVERAGE

Appendix 8: Additional Forms, Cont.

APPENDIX 8


3. ADD-ON REQUESTS To request add-on testing or to obtain more information regarding add-on testing, contact the Client Relations Department:

UNIPATH CLIENT RELATIONS: 303.512.2210

PALM BEACH PATHOLOGY CLIENT RELATIONS: 561.659.0770

EASTERN CAROLINA PATHOLOGY CLIENT RELATIONS: 252.234.2841

Delivering superior quality patient care through teamwork and eceptional laboratory services is the mission of AP2 laboratories. The requisition and specimen barcode system utilized by Ap2 laboratories allows for optimal specimen tracking from collection through reporting to ensure specimens are never misplaced.

Ap2 offers specialty specific requisition forms which include:

➤ Breast pathology

➤ Cytology/Histology

➤ Dermatopathology

➤ GI Pathology

➤ Head and neck Pathology

➤ Hematopathology

➤ Tissue Pathology

➤ Urologic Pathology

➤ Women’s Health

For a sample of current requisitions, visit us online at:

To submit an order request for printed requisitions, call the supplies department:

UNIPATH 303.512.0888 303.512.2288 (Fax)

PALM BEACH PATHOLOGY 561.659.0770 561.659.0413 (Fax)

EASTERN CAROLINA PATHOLOGY 252.234.2841 252.234.9270 (Fax)

4. REQUISITIONS

UNIPATH: www.unipathdx.com

PALM BEACH PATHOLOGY: www.pbpdx.com

EASTERN CAROLINA PATHOLOGY: www.ecpdx.com


1. COUNSYL – INFORMED PREGNANCY SCREENThe Informed Pregnancy Screen uses massively parallel sequencing to screen a maternal blood sample for fetal chromosomal abnormalities including: Trisomy 21, 18, 13, with an option to add screening for abnormal sex chromosome numbers and 5 common microdeletions.The screen can be run as early as 10 weeks gestation for both high and low risk women, as well as for women with an egg donor or multiple pregnancies.

SPECIMEN COLLECTION

MATERIALS REQUIRED

1 Needle and syringe for blood draw2 2 x 10mL provided cell-free DNA streck BCT

tubes3 Provided specimen transport materials

PROCEDURE

1 Collect 2 x 10mL of whole blood from the mother in the provided cell-free DNA Streck BCT tubes. Promptly tilt tube back and forth 2-3 times to ensure proper mixing of preservative.

2 Label tubes. Package the specimen using the provided transport materials and instructions listed in shipping container

3 Forward to AP2 laboratory with completed requisition and billing information

2. INTERPACE DIAGNOSTICS – ThyGenX THYROID PANELThyGenX is a panel of molecular markers which can aid in the diagnosis of thyroid cancer and improve preoperative diagnostic accuracy for patients with indeterminate thyroid nodules. The panel consists of 17 validated molecular markers and utilizes fine needle aspirate (FNA) specimens, collected in a separate container, nucleic acid preservation solution (RNA retain) at the time of the procedure. Clinicians are still able to use their choice pathologist and then reflex to Interpace Diagnostics if necessary.

Due to the indeterminate nature of this diagnosis (occurring 10-40%), the test is a complement to the tradition FNA diagnosis. This test works off of a Positive Predictive Value when issuing a diagnosis. It is stated by Interpace Diagnostics that because of the multiples scientific studies, ThyGenX can aid physicians in diagnosis and patient management decisions.

SPECIMEN COLLECTION

MATERIALS REQUIRED

1 Needle and syringe for FNA.2 RNA Retain® Collection Kit for FNA.

3 Specimen shipping kit.

PROCEDURE

1 Remove the small RNA Retain® vial from kit and unscrew top.

2 Upon collection, immediately add FNA biopsy to vial, washing the needle only 1-2 times.

3 Screw top back on vial and add bar-coded label.

4 Invert 2-3 times. 5 Place specimen vial in Styrofoam insert

and seal specimen collection bag around Styrofoam and vial.

6 Place sealed sample bag back into kit. 7 Fold and place completed requisition form

and patient billing information inside box but, outside of specimen collection bag.

8 Forward specimen to laboratory with completed requisition and billing information.

3. MDXHEALTH – CONFIRM MDXHEALTH FOR PROSTATE CANCERConfirmMDx for prostate cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those who may have

APPENDIX 9: REFERENCE LABORATORY INFORMATION

APPENDIX 9


occult cancer. The test helps urologists rule-out prostate cancer-free men from undergoing unnecessary repeat biopsies and helps rule-in high risk patients who may require repeat biopsies and potential treatment.

Per MDx Health, ConfirmMDx detects an epigenetic field effect or “halo” associated with the cancerization process at the DNA level in cells adjacent to the cancer foci. This epigenetic “halo” around a cancer lesion can be present despite having a normal appearance under the microscope.

SPECIMEN COLLECTION

MATERIALS REQUIRED

1 Formalin collection vials.

PROCEDURE

1 Collect prostate biopsies in formalin collection vials.

2 Check ConfirmMDx reflex test request on requisition.

3 Forward specimens to laboratory with completed requisition and billing information.

4 The test is performed as a reflex request after biopsies have been received by laboratory.

5 Sample requirements:

a The laboratory will cut 20 microns per block to send to MDxHealth.

6 If the histology is negative, the specimen will be sent to MDxHealth for testing.

4. NEODIAGNOSTIX – CERVICAL DNA DTEX TESTCervical DNA Dtex test is available in conjunction with a HPV High Risk Positive and/or an abnormal cytology pap result. The test investigates the cervical cells at a DNA level to diagnose disease. The test utilizes a standard liquid based cytology sample, so that no additional samples or procedures are required.

Per NeoDiagnostix, Dtex is based on biomarkers 3q26 and 5p15 and utilizes conventional fluorescent in-situ hybridization (FISH) to identify irreversible DNA damage to cervical cells.

SPECIMEN COLLECTION

MATERIALS REQUIRED

1 ThinPrep® or SurePath™ liquid cytology collection vial.

2 Cytobrush, broom or spatula.

PROCEDURE

1 Collect cervical specimen in liquid cytology collection vial per normal procedure.

2 Request Cervical DNA Dtex as a reflex on the requisition.

a Cervical DNA Dtex should be considered for patients with the following:

i Abnormal cytology (e.g. LSIS, ASCUS).

ii Testing positive for high risk HPV.


4 If results are abnormal, laboratory will forward to NeoDiagnostix to perform Cervical DNA Dtex testing.

5. PROGENITY – INNATAL PRENATAL SCREENThe Innatal Prenatal Screen (formerly verifi Prenatal Test) uses whole-genome massively parallel sequencing to screen a maternal blood sample for fetal chromosomal abnormalities including: Trisomy 21, 18, 13, and abnormal sex chromosome counts. Screening for trisomy 9, trisomy 16 and 5 common microdeletion is optional. The screen can be run as early as 10 weeks gestation for both high and low risk women, as well as for surrogacies, women with an egg donor and multiple pregnancies.

SPECIMEN COLLECTION

MATERIALS REQUIRED

1 Needle and syringe for blood draw

2 1 x 10mL provided cell-free DNA streck BCT tube

3 Specimen transport materials

PROCEDURE

1 Collect 1 x 10mL of whole blood from the mother in the provided cell-free DNA Streck BCT tube. Minimum volume is 7mL. Gently


invert the tube 8-10 times to ensure proper mixing of the preservative.

2 Label tube and package specimen using the transport materials and provided instructions. Do not refrigerate specimen.

3 Forward to AP2 laboratory with completed requisition and billing information

6. SEQUENOM - MATERNIT21 PLUS (NIPT) AND HEREDIT (CARRIER SCREENING)NIPT TEST (MATERNIT21 PLUS): Massively parallel sequencing test developed and validated by Sequenom Center for Molecular Medicine (SCMM), includes trisomies 21, 18, 13, 16, 22 and select copy number of variants. Testing for all conditions is included in the original test price; there are no additional fees as they add additional tests to MaterniT21 PLUS).

HEREDIT (CARRIER SCREENING): Laboratory-developed test that analyzes 136 mutations and 5 variants.

SPECIMEN COLLECTION

MATERNIT21 PLUSMATERIALS REQUIRED

1 Needle and syringe for blood draw.

2 2 x 10 mL provided Sequenom whole blood collection tubes.

3 Specimen transport materials.

PROCEDURE1 Collect 2 x 10 mL whole blood in the

provided collection tubes.

2 Package specimen using the transport materials.

3 Forward to laboratory with completed requisition and billing information.

HEREDIT CARRIER SCREENINGMATERIALS REQUIRED

1 Needle and syringe for blood draw.

2 1 x 10 mL lavender top EDTA whole blood collection tube.

3 Specimen transport materials.

PROCEDURE

1 Collect 1 x 10 mL whole blood in the provided lavender top EDTA collection tube.

2 Package specimen using the transport materials.

3 Forward to laboratory with completed requisition and billing information.

7. UNIVERSITY OF COLORADO – DIRECT IMMUNOFLUORESCENCE (DIF)Direct Immunofluorescence tests for cases involving autoimmune and inflammatory skin diseases.

SPECIMEN COLLECTION

MATERIALS REQUIRED

1 Michel’s vial collection container.

PROCEDURE

1 Put one specimen into Michel’s vial following biopsy.

2 On the AP2 requisition, check DIF test.

3 Place the Michel’s vial into the biohazard specimen bag with the rest of the patient’s formalin jars and laboratory requisition.


APPENDIX 9

Appendix 9 - REFERENCE LABORATORY INFORMATION Cont.


APPENDIX 10: LABORATORY TEST DIRECTORY (ALPHABETICAL ORDER)

TEST NAME: AML/MYELOID

TEST DESCRIPTION: Aids in the diagnosis of hematopoietic neoplasms, specifically acute myloid lymphomas.

METHODOLOGY: Flow Cytometry

SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Bone marrow or peripheral blood: Green-top (sodium heparin) tube preferred, lavender-top (EDTA) tube, or yellow-top (ACD) tube (acceptable, not preferred)

➤ Solid tissue/FNA: RPMI media, sterile saline (acceptable, not preferred)

SPECIMEN PREPARATION: Transport 2-7 mL heparinized bone marrow OR 3-5 mL whole blood OR 5 mm solid tissue suspended in tissue culture media (e.g., RPMI 1640).

STORAGE/TRANSPORT TEMPERATURE: Bone marrow specimens should be received within 24 hours of collection and peripheral blood/solid tissue/FNA specimens should be received within 24 hours of collection.

➤ Bone marrow or peripheral blood: Room temperature. DO NOT REFRIGERATE.

➤ Tissue or FNA: Transport on “wet ice”. DO NOT USE DRY ICE AND DO NOT FREEZE.

➤ Call lab immediately for STAT pickup:

UniPath 303.512.0888

Palm Beach Pathology 561.659.0770

Eastern Carolina Pathology 252.234.2841

REMARKS: Include relevant clinical history and CBC

STABILITY: Room temperature – 48 hours, Refrigerated – 48 hours, Frozen – unacceptable.

REJECTION CRITERIAFrozen, clotted or hemolyzed specimens; fixed specimens; not enough specimen; improper labeling on specimen collection.

INTERPRETIVE DATAASSAY SCHEDULE: Monday – Friday, STAT on-call available weekends

REPORTED: Verbal results available within 24 hours of specimen receipt

CPT CODE(S): 88184 1st marker, 88185 each

additional marker; 88187 or 88188 or 88189 interp.

TEST NAME: ALPSTEST DESCRIPTION: Aids in the diagnosis of Autoimmune Lymphoproliferative Syndrome.


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Bone marrow or peripheral blood: Green-top (sodium heparin) tube preferred, lavender-top (EDTA) tube, or yellow-top (ACD) tube (acceptable, not preferred).

➤ Solid tissue/FNA: RPMI media, sterile saline (acceptable, not preferred).



➤ Bone marrow or peripheral blood:

➤ Room temperature. DO NOT REFRIGERATE.



UniPath 303.512.0888



APPENDIX 10


REMARKS: Include relevant clinical history and CBC.

STABILITY: Room temperature – 48 hours, Refrigerated – 48 hours, Frozen – unacceptable


INTERPRETIVE DATAASSAY SCHEDULE: Monday – Friday, STAT on-call available weekends.

REPORTED: Verbal results available within 24 hours of specimen receipt.

CPT CODE(S): 88184 1st marker, 88185 each additional marker; 88187 or 88188 or 88189 interp.

TEST NAME: ANAL CYTOLOGY W/ HR HPVTEST CODE: 20042

TEST DESCRIPTION: Enhanced detection of high risk HPV in ano-rectal mucosa.

METHODOLOGY: Hybrid capture

SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: SurePath™ vial or ThinPrep vial®.

SPECIMEN PREPARATION: Collect ano-rectal specimen with cytobrush. Swab the distal 4-5 cm of the anal rectal mucosa to sample the anal sphincter and transformation zone, maintaining gentle pressure against the anal canal. Agitate brush in collection vial and tighten lid.

STORAGE/TRANSPORT TEMPERATURE: Maintain specimen at room temperature.

REMARKS:

STABILITY: Room temperature – 28 days; Frozen – unacceptable

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper

labeling; specimen collected from any other source than anus; expired collection device.

INTERPRETIVE DATAREPORTED: 1-7 days

CPT CODE(S): 87621

TEST NAME: ANAL PAP ONLYTEST CODE: 20041

TEST DESCRIPTION: Enhanced detection of abnormal cells in ano-rectal mucosa.

METHODOLOGY: Liquid based cytology

SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: SurePath™ vial or ThinPrep® vial.

SPECIMEN PREPARATION: Collect ano-rectal specimen with cytobrush. Swab the distal 4-5 cm of the anal rectal mucosa to sample the anal sphincter and transformation zone, maintaining gentle pressure against the anal canal. Agitate brush in collection vial and tighten lid.

STORAGE/TRANSPORT TEMPERATURE: Maintain specimen at room temperature.

REMARKS:

STABILITY: Room temperature – 28 days; Frozen – unacceptable.

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen collected from any other source than anus; expired collection device.


CPT CODE(S): 88112

TEST NAME: ATOPOBIUM VAGINAETEST CODE: 70142

TEST DESCRIPTION: Vaginal flora bacteria, predictive marker of Bacterial Vaginosis

METHODOLOGY: Real-time PCR

Appendix 10: Laboratory Test Directory, Cont.

APPENDIX 10


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Vaginal swab (UniSwab™), SurePath™, ThinPrep®.

SPECIMEN PREPARATION: Place collected specimen in transport medium. Swab/medium is available by contacting Supplies at:

UniPath 303.512.0888



STORAGE/TRANSPORT TEMPERATURE: Ambient temperature or refrigerated.

REMARKS: Specimen source required.

STABILITY: UniSwab™& ThinPrep® specimens are stable at room temperature for 28 days. Extracted DNA specimens are stable for up to 45 days. SurePath™specimens require immediate extraction for non CT/NG & HPV testing.

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen collected from any other source than vagina; expired collection device.

INTERPRETIVE DATA Can be added on for up to 45 days from initial collection when another molecular test (excluding Chlamydia, Gonorrhea, or HPV) are ordered up front. When no molecular test has been ordered up front, testing can be added on for up to 28 days on ThinPrep® collection only.

REPORTED: 1-5 days

CPT CODE(S): 87798

TEST NAME: BACTEROIDES FRAGILIS

TEST CODE: 70125

TEST DESCRIPTION: Anaerobic, gram-negative bacterium


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Vaginal swab (UniSwab™), SurePath™, ThinPrep®


UniPath 303.512.0888






REJECTION CRITERIA Inappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen collected from any other source than vagina; expired collection device.

INTERPRETIVE DATACan be added on for up to 45 days from initial collection when another molecular test (excluding Chlamydia, Gonorrhea, or HPV) are ordered up front. When no molecular test has been ordered up front, testing can be added on for up to 28 days on ThinPrep collection only.

REPORTED: 1-7 days

CPT CODE(S): 87798


TEST NAME: BACTERIA VAGINOSIS ASSOCIATED BACTERIA 2 (BVAB2)TEST CODE: 70164

TEST DESCRIPTION: Vaginal flora bacteria, predictive marker of Bacterial Vaginosis.


SPECIMEN REQUIRED



UniPath 303.512.0888







INTERPRETIVE DATACan be added on for up to 45 days from initial collection when another molecular test (excluding Chlamydia, Gonorrhea, or HPV) are ordered up front. When no molecular test has been ordered up front, testing can be added on for up to 28 days on ThinPrep® collection only.

REPORTED: 1-7 days

CPT CODE(S): 87798

TEST NAME: CANDIDA ALBICANS

TEST CODE: 70551

TEST DESCRIPTION: Vaginal flora fungus, predictive marker of vulvovaginal candidiasis in symptomatic women


SPECIMEN REQUIRED



UniPath 303.512.0888








REPORTED: 1-5 days because of PBP

CPT CODE(S): 87481

APPENDIX 10



TEST NAME: CANDIDA GLABRATA

TEST CODE: 70559

TEST DESCRIPTION: Predictive marker for vulvovaginal candidiasis in symptomatic women.


SPECIMEN REQUIRED



UniPath 303.512.0888






REJECTION CRITERIA Inappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen collected from any other source than vagina; expired collection device.


REPORTED: 1-5 days

CPT CODE(S): 87481

TEST NAME: CANDIDA KEFYR

TEST CODE: 70561

TEST DESCRIPTION: Vaginal flora fungus, predictive marker vulvovaginal candidiasis


SPECIMEN REQUIRED



UniPath 303.512.0888





STABILITY: UniSwab™& ThinPrep® specimens are stable at room temperature for 28 days. Extracted DNA specimens are stable for up to 45 days. SurePath™ specimens require immediate extraction for non CT/NG & HPV testing.



REPORTED: 1-7 days

CPT CODE(S): 87481


TEST NAME: CANDIDA KRUSEITEST CODE: 70560

TEST DESCRIPTION: Vaginal flora fungus, predictive marker of vulvovaginal candidiasis


SPECIMEN REQUIRED



UniPath 303.512.0888








REPORTED: 1-7 days

CPT CODE(S): 87481

TEST NAME: CANDIDA PARAPSILOSISTEST CODE: 70558



SPECIMEN REQUIRED



UniPath 303.512.0888




REMARKS: Specimen source required




REPORTED: 1-5 days

CPT CODE(S): 87481

APPENDIX 10



TEST NAME: CANDIDA TROPICALISTEST CODE: 70557



SPECIMEN REQUIRED



UniPath 303.512.0888








REPORTED: 1-5 days

CPT CODE(S): 87481

TEST NAME: CHLAMYDIA TRACHOMATISTEST CODE: 70105

TEST DESCRIPTION: Detects intracellular pathogen that infects the reproductive system in males and females.

METHODOLOGY: Strand displacement amplification.

SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Vaginal swab (UniSwab™), SurePath™, ThinPrep®, BD Self-Collection Device.


UniPath 303.512.0888







INTERPRETIVE DATACan be added on for up to 28 days from initial collection when another molecular test is ordered up front for SurePath™ collection devices. When no molecular test has been ordered up front, testing can be added on for up to 28 days on ThinPrep® and UniSwab™ collection devices.

REPORTED: 1-5 days


CPT CODE(S): 87491

TEST NAME: CHLAMYDIA TRACHOMATIS (URINE SPECIMEN)TEST CODE: 70400

TEST DESCRIPTION: Can be used to detect for male and female urine specimens from symptomatic and asymptomatic individuals.

METHODOLOGY: Strand displacement amplification.

SPECIMEN REQUIRED

PATIENT PREPARATIONPatient should not have urinated for at least 1 hour prior to specimen collection.

COLLECT: Patient should collection the first 20 – 60 mL of voided urine (the first part of the stream – NOT midstream) into urine collection cup.

SPECIMEN PREPARATION: Transfer urine using a pipette to the BD Urine Preservative Transport Tube. The correct volume of urine has been added when the fluid level is between the purple lines on the fill window located on the label. DO NOT overfill or under fill the tube. Discard the transfer pipette. Invert the tube 3-4 times to ensure that the specimen and reagent are well mixed. Note: transfer pipette is intended for use with a single specimen.

Urine tubes are available by contacting Supplies at:

UniPath 303.512.0888



STORAGE/TRANSPORT TEMPERATURE: Room temperature.

REMARKS: Specimen site required.

STABILITY: Room temperature – 28 days, Refrigerated – 28 days, Frozen – unacceptable.

REJECTION CRITERIA Inappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen collected from any other source

than urine; expired collection device; under-filled or over-filled collection device.

INTERPRETIVE DATANo add-ons.

REPORTED: 1-5 days

CPT CODE(S): 87491

TEST NAME: CLL/LYMPHOMATEST DESCRIPTION: Aids in the diagnosis of hematopoietic neoplasms, specifically chronic lymphocytic leukemia.


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Bone marrow or peripheral blood: Green-top (sodium heparin) tube preferred, lavender-top (EDTA) tube, or yellow-top (ACD) tube (acceptable, not preferred).

SOLID TISSUE/FNA: RPMI media, sterile saline (acceptable, not preferred).






UniPath 303.512.0888




APPENDIX 10








TEST NAME: EGGERTHELLA – LIKE BACTERIATEST CODE: 70175



SPECIMEN REQUIRED



UniPath 303.512.0888








REPORTED: 1-7 days

CPT CODE(S): 87798

TEST NAME: GARDNERELLA VAGINALISTEST CODE: 70132



SPECIMEN REQUIRED



UniPath 303.512.0888









REPORTED: 1-5 days

CPT CODE(S): 87511

TEST NAME: GROUP A STREPTOCOCCUS WITH PYOGENIC C/GTEST CODE: 70604

TEST DESCRIPTION: Qualitative detection and differentiation of Group A ß-hemolytic Streptococcus and pyogenic Group C and G ß-hemolytic Streptococcus bacteria


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Throat swab (ESwab)


UniPath 303.512.0888

Palm Beach Pathology 561.659.0770Eastern Carolina Pathology 252.234.2841



STABILITY: ESwab specimens can be stored at room temperature or refrigerated for up to 7 days.

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen collected from any other source than throat expired collection device.

REPORTED: 1-5 days

CPT CODE(S): 87651

TEST NAME: VAGINAL/RECTAL GROUP B STREP (GBS)TEST CODE: 70127

TEST DESCRIPTION: Aids in the isolation and identification of Group B Streptococci (Streptococcus agalactiae).

METHODOLOGY: PCR

SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Vaginal/Rectal swab. Swab the vagina first, followed by the rectum.

SPECIMEN PREPARATION: Place collected specimen swab in transport medium. Swab/medium is available by contacting Supplies at:

UniPath 303.512.0888



STORAGE/TRANSPORT TEMPERATURE: Refrigerated.


STABILITY: Refrigerated – 48 hours, Frozen – unacceptable.

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; transported and delivered at ambient temperature; improper labeling; specimen received after prolonged delay (more than 6 days); cervical/endocervical specimen or any source other than vagina and rectum; expired collection device.

INTERPRETIVE DATAFor antibiotic susceptibility testing use

APPENDIX 10



TEST CODE: 70137. Susceptibility testing may be added on for 28 days from receipt. Reflex susceptibility testing is encouraged to be ordered up front, as GBS organisms have decreased viability with delays in ordering susceptibility tests.

REPORTED: 1-3 days. Susceptibility testing will add 2-3 days

CPT CODE(S): 87081, 87653

TEST NAME: VAGINAL/RECTAL GROUP B STREP (GBS) ANTIBIOTIC SUSCEPTIBILITYTEST CODE:70137

TEST DESCRIPTION: Aids in the isolation and identification of Group B Streptococci (Streptococcus agalactiae), as well as detection of antibiotic susceptibilities.

SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Vaginal/Rectal swab. Swab vagina first, followed by rectum.


UniPath 303.512.0888



STORAGE/TRANSPORT TEMPERATURE: Refrigerated.


STABILITY: Refrigerated – 48 hours, Frozen – unacceptable.

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; transported and delivered at ambient temperature; improper labeling; cervical/endocervical specimen or any source other than vagina and rectum; expired collection device.

INTERPRETIVE DATA

For antibiotic susceptibility testing use

TEST CODE: 70137. Susceptibility testing may be added on for 28 days from receipt.

REPORTED: 3-8 days

CPT CODE(S): 87081, 87181x3, 37417

TEST NAME: HERPES SUBTYPE HERPES SIMPLEX VIRUS 1 AND 2 (HSV-1, HSV-2)TEST CODE: 60126

TEST DESCRIPTION: Identification and typing of herpes simplex virus. This test is for active infection and is not to be used to determine carrier status.


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: ➤ Females: cervical and vaginal swab specimens

including lesions.

➤ Males: swab collection of discharge from urethra or lesions..


UniPath 303.512.0888



STORAGE/TRANSPORT TEMPERATURE: Stored and transported at room temperature.

REMARKS: Specimen source required


REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper labeling; incorrect volume; expired collection device.



CPT CODE(S): 87529

TEST NAME: LACTOBACILLUS CRISPATUSTEST CODE: 70601

TEST DESCRIPTION: Vaginal flora bacteria


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Vaginal swab (UniSwab™), SurePath™, ThinPrep®. Note: Must be ordered with at least one bacterial vaginosis associated organism.


UniPath 303.512.0888







REPORTED: 1-7 days

CPT CODE(S): 87798

TEST NAME: LACTOBACILLUS GASSERITEST CODE: 70603



SPECIMEN REQUIRED



UniPath 303.512.0888








APPENDIX 10



REPORTED: 1-7 days

CPT CODE(S): 87798

TEST NAME: LACTOBACILLUS JENSENIITEST CODE: 70602



SPECIMEN REQUIRED



UniPath 303.512.0888








REPORTED: 1-7 days

CPT CODE(S): 87798

TEST NAME: MEGASPHAERA SPECIES TYPE 1TEST CODE: 70165



SPECIMEN REQUIRED



UniPath 303.512.0888







INTERPRETIVE DATACan be added on for up to 45 days from initial collection when another molecular test (excluding Chlamydia, Gonorrhea, or HPV) are ordered up front. When no molecular test has been ordered up front, testing can be added on for up to 28 days on


ThinPrep® collection only.

REPORTED: 1-7 days.

CPT CODE(S): 87798

TEST NAME: MEGASPHAERA SPECIES TYPE 2TEST CODE:71165



SPECIMEN REQUIRED



UniPath 303.512.0888






INTERPRETIVE DATACan be added on for up to 45 days from initial collection when another molecular test (excluding Chlamydia, Gonorrhea, or HPV) are ordered up front. When no molecular test has been ordered up front, testing can be added on for up to 28 days on

ThinPrep® collection only.

REPORTED: 1-7 days

CPT CODE(S): 87798

TEST NAME: MOBILUNCUS CURTISII

TEST CODE: 70801



SPECIMEN REQUIRED



UniPath 303.512.0888








APPENDIX 10



REPORTED: 1-5 days

CPT CODE(S): 87798

TEST NAME: MOBILUNCUS MULIERIS

TEST CODE: 70800



SPECIMEN REQUIRED



UniPath 303.512.0888








REPORTED: 1-5 days

CPT CODE(S): 87798

TEST NAME: MPN

TEST DESCRIPTION: Aids in the diagnosis of myeloproliferative neoplasms.


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT:➤ Bone marrow or peripheral blood: Green-top

(sodium heparin) tube preferred, lavender-top (EDTA) tube, or yellow-top (ACD) tube (acceptable, not preferred).







UniPath 303.512.0888





REJECTION CRITERIAFrozen, clotted or hemolyzed specimens; fixed specimens; insufficient specimen; improper labeling; expired collection device.





TEST NAME: MYCOPLASMA GENITALIUMTEST CODE: 70129

TEST DESCRIPTION: Associated with Pelvic Inflammatory Disease and/or Urethritis. Not associated with bacterial vaginosis.


SPECIMEN REQUIRED



UniPath 303.512.0888







INTERPRETIVE DATA

Can be added on for up to 45 days from initial collection when another molecular test (excluding Chlamydia, Gonorrhea, or HPV) are ordered up front. When no molecular test has been ordered up front, testing can be added on for up to 28 days on ThinPrep® collection only.

REPORTED: 1-5 days

CPT CODE(S): 87798

TEST NAME: MYCOPLASM GENITALIUM – URINETEST CODE: 70404

TEST DESCRIPTION: Associated with Urethritis

METHODOLOGY: Real-Time PCR

SPECIMEN REQUIRED


COLLECT: Patient should collect the first 20-60ml of voided urine (the first part of the stream — NOT midstream into urine collection cup.

SPECIMEN PREPARATION: Transfer urine using a pipette to the BD Urine Preservative Transport Tune. The correct volume of urine has been added when the fluid level is between the purple lines on the fill window located on the label. DO NOT over-fill or under-fill the tube. Discard the transfer pipette. Invert the tube 3-4 times to ensure that the specimen and reagent are well mixed. Note: transfer pipette is intended for use with a single specimen.


UniPath 303.512.0888




REMARKS: Specimen source is required.

STABILITY: Room temperature – 28 days. Refrigerated – 28 days. Frozen – unacceptable.

APPENDIX 10



REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen received after prolonged delay (more than 24 hours); specimen collected from any other source than urine; expired collection device; under-filled or over-filled collection device.


REPORTED: 1-5 days

CPT CODE(S): 87798

TEST NAME: MYCOPLASMA HOMINIS TEST CODE: 70130

TEST DESCRIPTION: Vaginal flora bacteria, predictive markers of Bacterial Vaginosis.


SPECIMEN REQUIRED



UniPath 303.512.0888






REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper

labeling; specimen collected from any other source than vagina; expired collection device.


REPORTED: 1-5 days

CPT CODE(S): 87798

TEST NAME: MYELOMATEST DESCRIPTION: Aids in the diagnosis of multiple myeloma.


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT:

➤ Bone marrow or peripheral blood: Green-top (sodium heparin) tube preferred, lavender-top (EDTA) tube, or yellow-top (ACD) tube (acceptable, not preferred).








UniPath 303.512.0888









TEST NAME: NEISSERIA GONORRHOEAETEST CODE: 70145

TEST DESCRIPTION: Used for detection in male and female urine specimens from symptomatic and asymptomatic individuals.

METHODOLOGY: Strand displacement amplification

SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Vaginal swab (UniSwab™), SurePath™, ThinPrep®, BD Self-Collection Device


UniPath 303.512.0888






REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper labeling; specimen received after prolonged delay (more than 48 hours); specimen collected from any other source than vagina; expired collection device.

INTERPRETIVE DATA

Can be added on for up to 28 days from initial collection when another molecular test is ordered up front for SurePath™ collection devices. When no molecular test has been ordered up front, testing can be added on for up to 28 days on ThinPrep® and UniSwab™ collection devices.

ASSAY SCHEDULE: Monday – Friday, STAT on-call available weekends.

REPORTED: 1-5 days

CPT CODE(S): 87591 TEST NAME: NEISSERIA GONORRHOEAE – URINE

TEST CODE: 70401


METHODOLOGY: Strand displacement amplification

SPECIMEN REQUIRED



APPENDIX 10





UniPath 303.512.0888








REPORTED: 1-5 days

CPT CODE(S): 87591

TEST NAME: PNHTEST DESCRIPTION: Aids in the diagnosis of paroxysmal nocturnal hemoglobinuria; a rare genetic blood disorder.


SPECIMEN REQUIRED

PATIENT PREPARATIONCOLLECT: Peripheral blood: Green-top (sodium

heparin) tube preferred, lavender-top (EDTA) tube, or yellow-top (ACD) tube (acceptable, not preferred).

SPECIMEN PREPARATION: 3-5 mL whole blood.

STORAGE/TRANSPORT TEMPERATURE: Peripheral blood specimens should be received within 24 hours of collection.

➤ Peripheral blood: Room temperature. DO NOT REFRIGERATE.


UniPath 303.512.0888





REJECTION CRITERIAFrozen, clotted or hemolyzed specimens; fixed specimens; not enough specimen; improper labeling; expired collection device.




TEST NAME: TRICHOMONAS VAGINALISTEST CODE: 70111

TEST DESCRIPTION: Used for diagnosis of Trichomonas vaginalis infection.


SPECIMEN REQUIRED

PATIENT PREPARATION


COLLECT: Vaginal swab (UniSwab™), SurePath™, ThinPrep®


UniPath 303.512.0888








REPORTED: 1-5 days

CPT CODE(S): 87661

TEST NAME: TRICHOMONAS VAGINALIS – URINETEST CODE: 70403



SPECIMEN REQUIRED





UniPath 303.512.0888








REPORTED: 1-3 days.

CPT CODE(S): 87661

TEST NAME: UREAPLASMA UREALYTICUMTEST CODE: 70320

APPENDIX 10



TEST DESCRIPTION: Use for enhanced detection of Ureaplasma urealyticum infection. This has been associated with urethritis and bacterial vaginosis.


SPECIMEN REQUIRED



UniPath 303.512.0888








REPORTED: 1-5 days

CPT CODE(S): 87798

TEST NAME: UREAPLASMA UREALYTICUM – URINETEST CODE: 70403

TEST DESCRIPTION: Used for the enhanced detection of Ureaplasma urealyticum which has been associated with urethritis.


SPECIMEN REQUIRED





UniPath 303.512.0888








REPORTED: 1-3 days.


CPT CODE(S): 87798

TEST NAME: URINE CYTOLOGYTEST CODE: 20002

TEST DESCRIPTION: Enhanced identification of cancer within the urinary tract.

METHODOLOGY: Microscopic examination

SPECIMEN REQUIRED

PATIENT PREPARATIONInstruct the patient to void and discard the first morning specimen. The patient should drink a quart of water a half hour to hour prior to collecting the urine specimen.

COLLECT: 50 mL minimum of: second morning specimen; voided or catheterized urine; intraoperative washings of urinary bladder, urethra, ureters, or renal pelvis.

SPECIMEN PREPARATION: Mix an equal amount of fixative (50% ethyl or methyl alcohol, or CytoLyt®) with the urine specimen

STORAGE/TRANSPORT TEMPERATURE: Refrigerate.

REMARKS: Urine should be identified as to type of sample (i.e. voided, catheterized, right or left ureteral or bladder irrigation fluid).

STABILITY: Ambient temperature – 12 hours, Refrigerated – 72 hours, Frozen – unacceptable.

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; specimen leakage; improper labeling; specimen received after prolonged delay (more than 48 hours); expired collection device; frozen specimen.

INTERPRETIVE DATAFor detection of cancer of ureters or kidneys, a serial collection of specimens spaced over three days has proven to increase diagnostic sensitivity and yield. Sensitivity and yield of urine specimens has also been shown to increase with optimal collection and preservation of specimen. Unpreserved urine results in the rapid

degeneration of exfoliated cells and may become useless for diagnosis.

REPORTED: Within 48 hours of receipt of specimen.

CPT CODE(S): 88112

TEST NAME: VARICELLA ZOSTER VIRUS (VZV)TEST CODE: 70600

TEST DESCRIPTION: Detection of varicella zoster virus from skin or genital lesion. This test is not to be used for carrier screening.


SPECIMEN REQUIRED

PATIENT PREPARATIONCollect: Skin or genital lesion swab (UniSwab™)


UniPath 303.512.0888





STABILITY: UniSwabTM specimens are stable at room temperature for 28 days.

REJECTION CRITERIAInappropriate specimen transport medium; inappropriate transport conditions; improper labeling; expired collection device.

INTERPRETIVE DATA REPORTED: 1-7 days

CPT CODE(S): 87798

APPENDIX 10



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