+--------------------------------+----------------------+-------------+
| **BROOKHAVEN NATIONAL          | GCRC POLICY: IC-08   | PAGE 1 OF 4 |
| LABORATORY**                   |                      |             |
|                                |                      |             |
| ###  GENERAL C                 |                      |             |
| LINICAL RESEARCH CENTER POLICY |                      |             |
+--------------------------------+----------------------+-------------+
|                                | PREPARED BY: B.      |             |
|                                | Pyatt Infection      |             |
|                                | Control              |             |
+--------------------------------+----------------------+-------------+
| SUBJECT: Clinical Laboratory   | REVIEWED BY: W.      |             |
| Operations of the GCRC &       | Gunther GCRC Manager |             |
| Satellite Facilities           |                      |             |
+--------------------------------+----------------------+-------------+
|                                | APPROVED BY: G. J.   |             |
|                                | Wang Medical Dept.   |             |
|                                | Chair                |             |
+--------------------------------+----------------------+-------------+
|                                | EFFECTIVE DATE:      |             |
|                                | 3-25-08              |             |
+--------------------------------+----------------------+-------------+
|                                | REVISION HISTORY: 5  |             |
+--------------------------------+----------------------+-------------+

**1.0 [PURPOSE:]{.underline}**

This document defines infection control requirements for program
specific clinical laboratory operations. Clinical operations consist of
any clinical diagnostic tests. These activities occur both in the
Central GCRC and the GCRC Satellite facilities (see GCRC Policy 1.2).

**2.0 [POLICIES:]{.underline}**

**STANDARD PRECAUTIONS**

**Standard Precautions shall be used by all laboratory employees at all
times when handling any and all laboratory specimens. [There are to be
absolutely no exceptions to the use of universal
precautions.]{.underline} Handwashing is the single most effective
deterrent to the spread of infection. (Dept. Guideline, IC-6.1/1,
"Bloodborne Pathogens Exposure Control Plan").**

Hands must be washed whether gloves are worn or not worn.

1.  After contact with all subjects

2.  After handling any specimen

3.  After contact with each specimen batch. For example at:

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a.  Accession labeling, centrifugation

b.  Stopper removal

c.  Separator insertion

d.  Specimen transfers

2.4 After skin contact with any biological sample of any reagent

2.5 After completing work

2.6 Prior to and after eating, drinking, smoking

2.7 Prior to and after use of restroom

## 

## 

## 3.0 ATTIRE:

Laboratory coats, uniforms or fluid resistant gowns must be worn by all
Laboratory staff during specimen procurement, handling and testing.
Fluid resistant gowns may not be worn out of the lab.

Laboratory coats, uniforms or fluid resistant gowns upon which
biological material has been spilled are a biohazard and must be
expediently removed and sent to be laundered or disposed of as regulated
medical waste.

# 4.0 [LABORATORY CLEANLINESS:]{.underline}

> 4.1. At the end of the day, laboratory staff members are responsible
> for leaving their bench and area neat and clean.
>
> 4.2. Once a day, the work area shall be wiped down with 1:10 diluted
> household bleach solution. In addition, all racks, pipettes, blood
> tube holders, centrifuges, ice containers etc. shall also be
> disinfected. Dirty underpads on counters shall be replaced.
>
> 4.3. The specimen collection area will be kept clean and orderly and
> free of waste materials. All waste materials will be placed in the
> receptacles provided. IV bags shall not be left in the sink where
> hands are washed. These are considered contaminated.

**5.0 [PROCEDURES:]{.underline}**

5.1. Collection of blood and body fluids **(SAFETY DEVICE NEEDLES SHALL
BE USED IN MOST INSTANCES including winged (butterfly") safety needles,
blunt collection needles, disposable blood collection multi-sample luer
adapters, collection needles with recapping sheath, and hinged recapping
sheath needles.)**

1\) Specimen collection personnel shall use appropriate barrier
techniques during subject contact.

2\) Use aseptic technique and disposable equipment between subjects,
during site preparation and before procedure.

> a\) Avoid multiple venipunctures at same site.
>
> b\) Use sterile collecting tubes, plastic if available.

3\) Avoid multiple sticks in same site when obtaining capillary
specimens, and use sterile equipment.

+--------------------------------+-------------------+-----------------+
| **BROOKHAVEN NATIONAL          | GCRC POLICY:      |                 |
| LABORATORY**                   | IC-08/5           |                 |
|                                |                   |                 |
| ### GENERAL CL                 |                   |                 |
| ILNICAL RESEARCH CENTER POLICY |                   |                 |
+--------------------------------+-------------------+-----------------+
|                                | Date              | > PAGE 2 OF 4   |
+--------------------------------+-------------------+-----------------+
| Clinical Laboratory Operations |                   |                 |
| of the CRC & Satellite         |                   |                 |
| Facilities                     |                   |                 |
+--------------------------------+-------------------+-----------------+

4\) For routine blood draws: Cleanse skin with alcohol, and do not
palpate site after skin preparation.

For blood cultures: Cleanse culture bottle stoppers with alcohol,
cleanse skin with alcohol and iodophor, allow iodophor to dry before
performing venipuncture, and do not palpate site after skin preparation.

5\) For IV and IA procedures, follow Dept. Guideline IC-2.2/3,
"Intraveneous Admixtures" and Dept. Guideline IC-3.0/3 "Sterile Supplies
Procedures".

**[CRITERIA TO SELECT SAFETY DEVICES:]{.underline}**

**The FDA suggests the following criteria be used in the selection of
safety devices:**

1\. The safety feature should provide a barrier between the hand and the
needle after use

2\. The safety feature should allow or require the worker's hands to
remain behind the needle at all times

3\. The safety feature should be an integral part of the device and not
an accessory

4\. Safety features should be in effect before disassembly and remain in
effect after disposal, to protect workers who may subsequently handle
the device

5\. The device should be simple and easy to use, requiring little or no
training

5.2 Transporting and receiving specimens in the laboratory

> 1\) Label specimens properly.

2\) Make sure specimens are properly closed and double-bagged.

> 3\) Use containers with secure closures, to avoid spillage and hand
> contamination with body fluids.
>
> 4\) Flag specimens at collection site to indicate infected subject as
> source.
>
> 5\) Instruct courier or messenger service personnel how to transport
> specimens properly so as to prevent spills, leaks or contamination.

6\) Refrigerators/freezers that store specimens shall be properly
labeled and monitored for accurate temperature with a NIST thermometer
and daily temperature log sheets.

7\) Specimens transported between satellite facilities shall be done
using a BNL vehicle or your own vehicle using the proper secondary
container. Permission needs to be obtained from our BNL Dept. of
Transportation Safety Officer.

5.3. In order to prevent

> \- Accidental ingestion of material containing agents, eg.,
> *Salmonella, Shigella*, hepatitis A or enterovirus.
>
> \- Inoculation or contact with fluids containing hepatitis B or C.
>
> \- Respiratory spread (inhalation) from aerosolization of agents,
> e.g., *Mycobacterium tuberculosis*:

1\) Use caution with pipetting procedures.

> a\) Do *not* perform mouth pipetting of infectious or toxic biological
> fluids, sera, or any biohazardous material.
>
> b\) Do *not* prepare bacterial suspensions by bubbling air through
> liquid by means of a pipette.
>
> c\) Do *not* blow infectious material out of pipettes.

d\) When using automatic pipettors, do not forcefully eject the solution
from the pipette (to prevent aerosolization).

> e\) Dispose of pipettes properly after use into a biohazard container.

Follow Tuberculosis Exposure Control Plan IC-16.0/1.

2\) Clean up any spills of body fluids immediately.

> a\) Keep wash bottle of disinfectant at each workstation.
>
> b\) Wear gloves for contaminated spills.

3)  Clean up material that might involve possible aerosol generation of
    microorganisms

> a\) Evacuate rooms for 10 air changes.
>
> b\) Wear gloves, masks, and other necessary protective clothing while
> cleaning up small spills. For larger spills call X2222.

4\) Use care with operation of centrifuges and shakers.

> a\) Instruct operators with the proper use of the different types of
> centrifuges and shakers and that they wear full face shields when
> operating the centrifuge or use safety cups and covers in the
> centrifuge.
>
> b\) Check and clean or replace the rubber cushions in the centrifuge
> cups as necessary.
>
> c\) Check all tubes for cracks prior to use.
>
> d\) Balance tubes prior to centrifuging.
>
> e\) Use a brake to stop rotating head; *never* stop the rotating head
> with your hand.
>
> f\) Keep lid to the centrifuge closed while machine is being used.
>
> g\) Do not open centrifuge until completely stopped when centrifuging
> blood specimens.
>
> h\) Use stoppered tubes when centrifuging blood specimens.
>
> i\) Each employee who uses the centrifuge is responsible for the
> condition of it at the end of the procedure.
>
> j\) Microhematocrit and blood bank serological centrifuges must be
> cleaned daily, or after each run, with approved disinfectant solution.
> In case of breakage, cleaning and disinfections must be immediate.

k\) Specimens spun in angle head centrifuges must never be filled to the
extent that liquid will be in contact with the tube lips.

5\) Opening Specimen Containers and Transfer of Specimens.

a\) Do not pop vacuum container corks. Cork popping generates aerosols,
prime sources for bloodborne disease transmission. Cover corks with
gauze and twist them off gently. When disposed, corks and gauze must be
disposed of as medical waste. The wearing of a full face shield is
recommended when opening vacuum container corks.

6\) Control Sera and Reagents from Biological Sources:

a\) All material prepared from biological sources are biohazardous in
that they are high probability agents for transmission of disease. All
such materials must be treated as though they were specimens from high
risk subjects.

7\) Spills of Biological Samples:

Spills on paper or on disposable surfaces, any worksheet, request or
report upon which a biological sample has been spilled, should be
recopied and then disposed of.

Spills on nondisposable surfaces must be cleaned promptly with an
aqueous 1:10 dilution of bleach or approved disinfectant.

5.4 Obtain first aid for puncture wounds and follow procedure for
hepatitis B prophylaxis as required by the Bloodborne Pathogens Exposure
Control Plan (Dept. Guideline IC-6.1).

5.5 Disposal of contaminated wastes - follow Dept. Guideline IC-6.2,
\"Handling & Disposal of Regulated Medical Waste\".

**6.0 [PRODUCTS OF THE CLINICAL LABORATORY WHICH MAY INFLUENCE THE
INFECTION RISK TO]{.underline} [SUBJECTS AND/OR
PERSONNEL:]{.underline}**

6.1 Agents which may be transmitted by blood include:

> a\) Hepatitis viruses B & C, HIV.
>
> b\) *Toxoplasma gondii*.
>
> c\) *Plasmodium* (malaria organism).
>
> d\) Cytomegalovirus.
>
> e\) Epstein-Barr virus.
>
> f\) *Rickettsia rickettsii*.
>
> g\) Bacteria, usually gram-negative.

6.2 If the blood donors have not been screened for the following:

a\) Fever or acute illness.

b\) Dental surgery in past 72 hours.

c\) History of hepatitis, jaundice or close personal contact with a
person with viral hepatitis or jaundice.

d\) Narcotic drug addiction/alcoholism (normal controls).

e\) Infections at venipuncture site.

f\) Vaccination within past 2 weeks with a live-virus vaccine.

g\) Evidence of malaria-travel to, or resident of, endemic area (also if
on antimalarial drugs).

h\) Positive serology for syphilis.

i\) Recent evidence of infection with CMV or EB virus.

j\) HBsAg

Then it is the Principal Investigator's responsibility in his/her
protocol to identify the criteria for rejecting a blood donor's blood.

6.3 Control Sera and Reagents from Biological Sources:

All material prepared from biological sources are biohazardous in that
they are high probability agents for transmission of disease. All such
materials must be treated as though they were specimens from high risk
subjects.

**7.0 [SPECIFIC WORK PRACTICES IN THE LABORATORY TO DECREASE RISK OF
MICROBIAL ]{.underline}**

**[TRANSMISSION:]{.underline}**

7.1. Designate use of special clothing.

> a\. Remove laboratory coats or protective clothing worn in the
> Laboratory before leaving the area, especially, when going to the
> cafeteria or out of the building.
>
> b\. Use protective apparel as appropriate. See Guideline IC-6.1,
> \"Bloodborne Pathogens Exposure Control Plan\".

7.2. Evaluate exposure to communicable disease agents.

> a\. Keep screening tests current as required by the Employee Health
> Service.
>
> b\. Keep immunizations current.

**[NOTE:]{.underline}** All Clinical Lab. employees must be included in
the OMC Health Care Personnel Protocol

> c\. Require personnel to wear gloves when handling contaminated blood
> or specimens.
>
> d\. Do not permit eating, drinking, and smoking in the Laboratory
> procedure areas.
>
> e\. Do not store food in the laboratory refrigerators used for
> specimens or reagents.
>
> f\. Do not handle telephone, door knobs or laboratory notebooks with
> contaminated gloves.
>
> g\. Fingers, pencils, pens, and other objects that may be contaminated
> must be kept away from the mouth.
>
> h\. Do not apply cosmetics while in the designated work area.

i\. If a laboratory slip becomes contaminated with any biological
material, another slip must be prepared and the contaminated slip
destroyed.

> Procedures j-n shall be done behind a plastic screen to prevent
> aerosolization.
>
> j\. If the rubber stopper from the vacutainer needs to be removed,
> laboratory personnel should twist the stopper gently, covering it
> first with gauze to minimize aerosols.

k\. When ejecting a fluid specimen from a syringe, always remove the
needle first so as to minimize aerosols. Insert the syringe deep into a
large container, allowing the fluid to run down on the inside of the
container.

l\. All biological specimens should be covered, capped, corked or
plugged, except while being collected or in the process of separation
pouring or analysis.

m\. If the outside of a tube becomes contaminated with biological
material, it should be wiped off with disinfectant before others handle
it.

> n\. Biological specimens should be transferred through the use of a
> bulb suction pipette instead of pouring the specimen. If the specimens
> must be poured, any drips that may occur must be wiped up with
> disinfectant.
>
> o\. Subject's sterile and clean supplies shall be kept in a clean,
> closed cabinet; Other supplies shall be kept in separate cabinets.

p\. Laboratory room shall not be used as a storage area.

q\. Only cleaning supplies shall be stored under sinks.

r\. Unnecessary items shall not be brought into the laboratory as they
might become unknowingly contaminated. Such items include newspapers,
magazines, books, handbags and knapsacks.

**8.0 [HOUSEKEEPING AND CUSTODIAL SERVICES:]{.underline}**

For Custodial Services follow Dept. Guideline, IC-11/4, "Custodial
Services"

For Housekeeping Services follow Dept. Guideline, IC-12/4,
"Housekeeping"

**9.0 [ATTACHMENTS:]{.underline}**

1\. GCRC Satellite Facilities Where Clinical Lab Operations Occur

The only official copy of this file is the one online at the Medical
Department website under "Clinical Research Center Policy Manual."
Before using a printed copy, verify that it is the most current version
by checking the document effective date on the website.

Attachment 1

IC-08/5

**GCRC Satellite Facilities Where Clinical Lab Operations Occur**

1\. PETT IV-901

1.  MRI-560

2.  Cyclotron-906

3.  Clinic Lab 9-931