Table of Contents

University Diagnostic Laboratories 3

GENERAL INFORMATION 3

LOCATION 3

HOURS OF OPERATION 3

TELEPHONE COMMUNICATIONS 3

LABORATORY LICENSURE 4

TEST REQUEST PROCEDURE 4

Serology Test Requests 5

Hepatitis 5

Hepatitis C Confirmation 6

SPECIMEN TRANSPORT 7

REPORTING 7

COURIER SERVICES 8

CYTOLOGY 12

BONE MARROWS 21

POST MORTEM EXAMINATION 22

Permission for Post Mortem Exam 22

Procedures related to fetuses 23

SURGICAL PATHOLOGY 23

SPECIAL Billing issues for Surgical and Cytopathology 26

University Diagnostic Laboratories May 11, 2000

Policy and Procedure Manual ______

University Diagnostic Laboratories

GENERAL INFORMATION

LOCATION

--- Clinical Laboratories located in the UMDNJ - Robert Wood Johnson Medical School are operated under the auspices of the Robert Wood Johnson University Medical Group. Collectively, these laboratories are known as the University Diagnostic Laboratories and include laboratories in three medical school departments:

·  Department of Medicine

- Hematology and Special Coagulation Laboratory

- Hypertension Laboratory

·  Department of Obstetrics and Gynecology

- Reproductive Endocrinology

- Cytogenetics

- in Vitro Fertilization

·  Department of Pathology

- Serology

In addition, all Point of Care testing performed in the Clinical Academic Building is also operated under UDL licensure.

HOURS OF OPERATION

--- University offices are open from 8:30 a.m. to 4:30 p.m. Monday-Friday. Some specialty laboratories such as Serology begin testing earlier than 8:30 a.m. (7:30 a.m.). UDL Central Administrative offices are located in the Medical Education Building, Room 212 and staffed from 8:00 a.m. to 5:30 p.m.

TELEPHONE COMMUNICATIONS

--- Please use the following numbers to communicate with the University Diagnostic Laboratories:

Requests for courier service MEB 215 - 235-8769

General Information MEB 212 - 235-8110

Institutional Billing Information MEB 212 - 235-8112


UDL Laboratories

Cytogenetics CAB 7 - 235-6395

Hematology and Special MEB 3 - 235-7683

Coagulation

IVF Laboratory 303 George - 235-7325

Outpatient Surgical Path. MEB 2

Reproductive Endocrinology MEB 209 - 235-7636

Serology MEB 211 - 235-8768

LABORATORY LICENSURE

·  Clinical Laboratory License: New Brunswick -

Clinical Academic Building /Medical Education Building
125 Paterson St.

NJ Department of Health #: 16652

College of American Pathologists (CAP) #: 25685-01

CLIA #: 31D0125790

Bioanalytical Lab Director - Evan Cadoff, M.D. BLD # : MF00625

·  Clinical Laboratory License: New Brunswick -
303 George St.

NJ Department of Health #: 16653

CLIA #: 31D0898250

Bioanalytical Lab Director - Edita Bancila, M.D. BLD #: MF00684

·  Clinical Laboratory License: New Brunswick –

277 George St.

NJ Department of Health #: 16654

CLIA #: 31D0692814

Bioanalytical Lab Director - Edita Bancila, M.D. BLD #: MF00684

TEST REQUEST PROCEDURE

A number of different requisition forms are available to order testing through various UMG clinical laboratories. These requisition forms can be obtained by directly contacting the specialty laboratory performing the procedure. UDL Courier services will gladly transport requisitions to the requesting facility.

Serology Test Requests
Hepatitis

With at least 7 different forms of viral hepatitis (A through G) and several other viruses with the known potential to cause liver inflammation, the workup of viral hepatitis has grown increasing complex in the clinical setting.

To assist clinicians in this task, the UDL first developed a computerized interpretive algorithm to permit complex interpretations based upon the behavior of as many as 10 different serologic markers. When these serologic markers are requested simultaneously on a single patient the results are interpreted across the entire pattern of results.

Antibody responses to viral infections follow a rather predictable course. In general, the early immunologic response to virus- derived antigens is heralded by the appearance of specific IgM antibodies. Somewhat later in the course of the disease, IgG antibodies become prominent. This temporal pattern is a useful basis for differentiating acute from chronic infections. Additional markers assist in differentiating stages in the temporal progression of hepatitis. Sometimes, however, it is difficult to know which test or panel of tests to order. We offer the following panels in the Division of Serology:

Testcode / Purpose / Tests
520 / Screen for Hepatitis B / HBsAg, anti-HBs, HBcAb(Poly)
500 / Screen for Hepatitis A & B / HBsAg, anti-HBs, HBcAb(Poly), anti-HAV(Poly)
1057 / Screen for Hepatitis A, B & C / HBsAg,anti-HBs, HBcAb(Poly), anti-HAV(Poly)
561 / Screen for Acute Infection / Hepatitis Screen - Symptomatic (HBsAg, HBc(IgM), HAV(IgM), HCV)
530 / Screen for Hep. B Infectivity / HEPATITIS FOLLOWUP: Infectivity (HBeAg + HBeAb)
562 / Follow-up for Hep. B resolution / HEPATITIS FOLLOWUP: Chronic (HBeAg, HBeAb, anti-HBs)

It is not necessary to provide a separate tube for each marker requested. The Abbott Flexible Pipetting Center automatically pipets specimens for each test from a single 7 ml SST. A full 7 ml tube provides sufficient specimen to allow the complete workup of most patients infected with type B hepatitis.

Hepatitis C Confirmation

ELISA assays vary in sensitivity and specificity. First generation screening procedures are often sub-optimal, but because of the importance attached to eliminating a known infectious risk from the blood supply, they often find their first use in this environment. Invariably, confirmatory testing follows the development of the basic screening procedure.

All highly sensitive immunoassay systems have a potential for nonspecific reactions. A variety of approaches are taken to ensure the specificity of an ELISA result. One of these approaches is the Recombinant Immunoblot Assay or RIBA.

As a registered FDA donor testing facility, the UDL Division of Serology has recently introduced the third generation of confirmatory testing for HCV infection by multiple, recombinant HCV-encoded antigens, the Chiron RIBAâ HCV 3.0 Strip Immunoblot Assay.

This new generation of the RIBA assay has proven very useful in differentiating some specimens previously referred to as indeterminate. In one study1, the use of RIBA 3.0 to follow-up on repeatedly reactive 2nd generation EIA (enzyme linked immunoassay) results dramatically reduced the number of indeterminate outcomes (225 to 54 out of 732 tested).

The primary difference between the two RIBA assays is the addition of the NS5 recombinant antigen to the diagnostic strip and the consolidation of the two antigens associated with the membrane binding function (5-1-1p and c100p) into a single band. The two recombinant antigens (c33c and NS5) and two of the synthetic peptides (clOOp and 5-1-1p) are derived from putative non-structural regions of the virus, while the third peptide (c22p) corresponds to the putative nucleocapsid (core) viral protein. Since the recombinant HCV c33c and NS5 antigens are produced as individual fusion proteins with human superoxide dismutase (hSOD), recombinant HSOD has also been included as a control band on the strip.

There are some modest differences in how the assay is performed and in how it is interpreted. These differences are noted on the report.

SPECIMEN TRANSPORT

All specimens must be transported to the laboratories in plastic, biohazard, piggyback, sealed bag. SPECIMENS must be labeled directly on the tubes. Leaking or contaminated specimens or requisitions will not be accepted.

The UDL courier system is available to transport specimens in accordance with IATA standards in appropriate containers.

REPORTING

Each clinical laboratory is responsible for the generation of reports related to its specialty activity. Please contact the laboratories directly for follow-up of delayed or missing reports or with requests for addition of pertinent clinical information

COURIER SERVICES

The courier system serves laboratories at both RWJUH and the UDL. Couriers are available from 8 A.M. to 10 P.M. although courier scheduling is ONLY available between 8 A.M. and 4:30 P.M. For the most current schedule of pickups please contact Ms. Fran Jackson at (732) 235-8768. To request ad hoc pickups please call the same number.

SCHEDULED COURIER PICKUPS

8:00 am - St. Peter’s University Hospital (COURIER I)

Chemistry 6th floor - pickup specimens

Pathology 5th floor - pickup and deliver reporting for various Departments. Genetics 2nd floor

(Ultrasound dept.) - pickup specimens for cytogenetics, serology

Other departments as needed.

Monday and Thursdays (Following the 8 AM SPMC Pickup) ONLY

Edison Medical Group
Dr. Schneider – Bridgewater (12 – 6 pm)
Dr. Primmer – Belle Mead
Dr. Berger – Kendall Park
Dr. Weinstein – East Brunswick

10:00 am - Robert Wood Johnson University Hospital

Chemistry Laboratory 2nd floor

Pickup specimens for serology, flow cytometry and genetics, pickup and deliver reports for other departments as needed.

Surgical Pathology 2nd floor - Pickup reports for distribution

10:30 am- Clinical Academic Building

7th floor Cytogenetics - deliver specimens and pickup repts.

AFTERNOON PICKUPS

12:00 pm - Lunch and /or other duties that may arise.

12:30 pm- St. Peter's University Hospital.

Chemistry 6th floor - pickup specimens for clinical immunology, cytogenetics, and deliver and pickup reporting for various departments.

Histology 5th floor -

1:05pm - Clinical Academic Bldg.

7th Floor - Cytogenetics

Drop-off specimens. Deliver and pickup reports for various departments.

1:30 pm - Robert Wood Johnson University Hospital

2nd floor Laboratory

Pickup specimens and deliver reports for various departments.

1:45 pm - Piscataway.

2nd floor Pathology - deliver and pickup reports; EOHSI - pickup specimens, drop off reports

2:30 pm - Chandler

3:00 pm- St. Peter's University Hospital.

Chemistry 6th floor - pickup specimens for clinical immunology, cytogenetics, and deliver and pickup reporting for various departments.

2nd floor Genetics (Ultrasound dept.) - pickup specimens for cytogenetics, serology.

3:30 pm - CAB7 & Finalize pickups for UDL - MEB & RWJUH

4:00 pm - Specimens left for evening shift

EVENING PICKUPS - BLOOD BANKS

COURIER I

4:30 pm - Specimens racked for technologists’ day shift

5:00 pm - Finish on-call pickups that daytime courier cannot complete. Pickups for Oral Surgery (Livingston Ave.), Dr. Perry, Dr. Glasgold, Muhlenberg Reg. Med. Ctr.

6:30 pm - Dinner Break

7:00 pm - Dr. Shulman’s Office

7:30 pm - Chandler Health Center

7:45 pm - RWJUH - drop off specimens for RWJUH

8:15 pm - Raritan Bay Medical Center

8:30 pm - John F. Kennedy Medical Center

9:00 pm - Robert W. Johnson Dialysis Center

9:30 pm - Princeton Medical Center.

10:00 pm - Somerset Medical Center

10:30 pm - St. Peter’s University Hospital

11:00 pm - Clin. Acad. Bldg.- New Brunswick Affiliated Hospitals
Clin. Acad. Bldg.- Genetics 7th Floor
RWJUH Chemistry - 2nd Floor

11:30 pm - Return to UDL New Brunswick - MEB 211. Sort and rack specimens for AM shift

‘WILL-CALL’ PICKUPS - COURIER II

SCHEDULED BY CALLING:

(732) 235-8768

MONDAY THROUGH FRIDAY

Examples of ‘Will-Call’ Pickups:

Princeton Tcell, bone marrow, lymph node specimens, genetic specimens, histology specimens, (muscle biopsy, renal biopsy). STAT specimens.

Raritan Bay Medical Center - “ “

Somerset Medical Center - “ “

St. Peter's University Hospital - “ “

Various Physician Offices

(15 miles Central NJ) - Pickup specimens for serology, cytogenetics, hematopathology, histology.

Liberty Plaza - Deliver paperwork to grants, payroll, human resources

*NOTE: PLEASE NOTE THAT THERE ARE SCHEDULED COURIER PICKUPS TO MOST OF THESE DESTINATIONS DAILY. A REQUEST FOR AN AD HOC PICKUP SHOULD BE MADE ONLY ON THE BASIS OF A STAT NEED.

SCHEDULED COURIER II PICKUPS

11:00 am - 1 pm RWJUH @ Hamilton (COURIER II)

Pickup specimens for serology, flow cytometry and genetics, pickup and deliver reports for other departments.

05/11/00 - 3 of 25 - 10:10 AM

University Diagnostic Laboratories May 11, 2000

Policy and Procedure Manual ______

CYTOLOGY

To eliminate unsatisfactory or inadequate specimens and optimize cytodiagnosis by identifying collection and submission requirements of all cytology specimens. These procedures will be available in nursing manuals for on-site personnel and to out-patient providers.

a. Body Fluids: Pleural, Ascitic and Pericardial

Synonyms: Pleural Fluid Cytology; Thoracentesis Cytology; Ascitic Fluid Cytology; Paracentesis Cytology; Pericardial Fluid Cytology; Pericardiocentesis Cytology

Report and request form required: Cytology: specify site of collection; include pertinent clinical information; previous carcinoma, drugs, radiation therapy or history of alcohol abuse. Include physician's name and beeper number, patient's name, age and med record number.

Special instructions: Add 300 units of heparin per 100 mL of fluid.

Specimen required: Fresh body fluid during working hours.

Volume of specimen: Not less than 5 mL; 50-100mL recommended.

Container required: 100mL specimen container.

How specimen is to be collected and requisition completed: Label with patient's name, hospital number, room number, and date. Deliver immediately to Cytology. After hours send to main laboratory receiving.

05/11/00 - 11 of 25 - 10:10 AM

University Diagnostic Laboratories May 11, 2000

Policy and Procedure Manual ______

Causes for rejection by laboratory: Improper labeling, fixation or incomplete clinical information.

Availability: Weekdays, 7:30 a.m. - 4:30 p.m. Not STAT

Time required routinely for processing of specimen by laboratory: 24-48 hours

General use of the test: To establish the presence of primary or metastatic neoplasm.

Additional information required to process test: Call Cytology laboratory- Ext. 2067

Reference Range: Negative

b. Bronchial Washings and Tracheal Aspirations

Synonyms: Bronchial Washings Cytology; Bronchoalveolar Lavage Cytology; Tracheal Aspiration Cytology

Report and request form required: Cytology: patient's name, sex, age, pertinent clinical information, i.e., previous carcinomas. Also include physician name and beeper number.

Specimen required: Obtained by physician

Volume of specimen: Not less than 5-10 mL.

Container required: Deliver fresh specimen to the Cytology lab during working hours.

How specimen is to be collected and requisition completed: Label container with patient name, hospital number, room number, address and date. Deliver immediately to cytology lab. After hours send to main laboratory receiving. Causes for rejection by laboratory: Improper labeling or fixation

Availability: Weekdays, 7:30 a.m. - 4:30 p.m., not STAT.

Time required routinely for processing of specimen by laboratory: 24-48 hours

General use of the test: To establish the presence of primary or metastatic neoplasm

Limitations: Specimen is considered non diagnostic if respiratory epithelium is not present or if material is improperly preserved.

Reference Range: Negative

c. BRUSHINGS: Esophageal, Gastric, Small Bowel, Colonic, Etc.

Report and request form required: Cytology. Specify the site brushed. Include patient name, age and pertinent clinical date i.e., admitting diagnosis, history of carcinoma. Also, include physician's name and beeper number.