+--------------------------------+----------------------+-------------+
| **BROOKHAVEN NATIONAL          | GCRC POLICY: IC-16   | PAGE 1 OF 3 |
| LABORATORY**                   |                      |             |
|                                |                      |             |
| **GENERAL CLINICAL RESEARCH    |                      |             |
| CENTER POLICY**                |                      |             |
+--------------------------------+----------------------+-------------+
|                                | PREPARED BY: B.      |             |
|                                | Pyatt Infection      |             |
|                                | Control              |             |
+--------------------------------+----------------------+-------------+
| SUBJECT: TUBERCULOSIS EXPOSURE | REVIEWED BY: W.      |             |
| CONTROL PLAN                   | Gunther GCRC Manager |             |
+--------------------------------+----------------------+-------------+
|                                | APPROVED BY: G. J.   |             |
|                                | Wang Medical Dept.   |             |
|                                | Chair                |             |
+--------------------------------+----------------------+-------------+
|                                | EFFECTIVE DATE:      |             |
|                                | 3-25-08              |             |
+--------------------------------+----------------------+-------------+
|                                | REVISION HISTORY:6   |             |
+--------------------------------+----------------------+-------------+

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

This Policy defines the Tuberculosis Exposure Control Plan, the purpose
of which is to protect all at risk BNL Health Care Workers (HCW) and
GCRC research subjects and to establish infection control policies and
procedures that eliminate or minimize occupational exposure to
tuberculosis (TB).

**2.0 [DRIVERS]{.underline}**

> 2.1 DOE Order 440,1a Worker Protection Management for DOE Federal and
> Contractor Employees;
>
> CRD Chapter 19-Occupational Medicine
>
> 2.2 OSHA Proposed Rule Occupational exposure to tuberculosis; Federal
> Register 62:54159-54309, 10/17/1997.
>
> 2.3 CDC Guidelines for Preventing the Transmission of Mycobacterium
> Tuberculosis in Health-Care Facilities, 1994; MMWR 43(RR-13): i-132,
> 1994.

4.  CDC/Hospital Infection Control Practices Advisory Committee.
    Guidelines for infection control in health care personnel, 1998.
    [Am. J. Infect. Cntrl]{.underline}.26:289-354. 1998.

5.  Core Curriculum on Tuberculosis, Fourth Edition, 2000 CDC

2.6 Targeted Tuberculin Testing and Treatment of Latent Tuberculosis
Infection MMWR (CDC) 49(RR-6):1-2. June 9, 2000.

**3.0 RISKS**

Brookhaven National Laboratory's GCRC is a **low risk** institution by
the following definitions.

Low Risk:

3.1. \<6 TB patients hospitalized per year.

3.2. PPD conversion rate \</= areas/groups without occupational TB
exposures or previous rate.

3.3. No PPD conversion clusters

3.4. No evidence of subject-subject transmission.

Intermediate Risk:

3.1. \>6 TB patients hospitalized per year.

3.2. PPD conversion rate \</= areas/group without occupational TB
exposure or previous rate

3.3. No PPD conversion clusters

3.4. No evidenced of patient-to-patient transmission.

High Risk:

3.1. \>6 TB subjects hospitalized per year.

3.2. PPD conversion rate \> areas/group without occupational TB exposure
or previous rate.

3.3. There are PPD conversion clusters. (2 + in an area/occupational
group over 3 months).

3.4. There is evidence of subject-subject/HCW transmission

In addition, BNL is located in Suffolk County, N.Y. which reported a
case incidence rate of 5 per 100,000 during 2000, the most recent year
for which figures are available. This rate is [below]{.underline} the
national average of 6.9 cases per 100,000.

Diagnostic Risk:

1.  Positive PPD skin test (greater than 10mm induration, 5 mm if in the
    high risk group)

2.  Productive cough X six (6) weeks

3.  Fever, night sweats for greater than three (3) months

4.  Immigrated from an area where TB is endemic(i.e., Asia, Mexico,
    South America, Africa) and has been in the US for less than five (5)
    years

5.  Has a history of ETOH abuse or IV drug abuse

6.  Has a suspect chest X-ray or lungs show an infiltrate on X-ray

7.  Homeless and/or has recently been a prison or jail inmate

8.  Has a compromised immune system: HIV-infected, on immunosuppressive
    therapy

9.  A person who has had close contact with an individual with TB

**4. 0 [BNL EMPLOYEES ONLY]{.underline}**

The Occupational Medicine Clinic screens all employees at exposure risk
for the presence of inactive or active

+-----------------------------------+-----------------+-----------------+
| **BROOKHAVEN NATIONAL             | NUMBER: IC-16/6 |                 |
| LABORATORY**                      |                 |                 |
|                                   |                 |                 |
| **CLINICAL RESEARCH CENTER        |                 |                 |
| POLICY**                          |                 |                 |
+===================================+=================+=================+
|                                   | DATE            | PAGE 2 OF 3     |
+-----------------------------------+-----------------+-----------------+
| Tuberculosis Exposure Control     |                 |                 |
| Plan                              |                 |                 |
+-----------------------------------+-----------------+-----------------+

Tuberculosis at the time of employment and at least annually thereafter.
The TB program will also include any GCRC employee who is exposed to a
non-isolated subject having active Tuberculosis. They shall be referred
to OMC by their supervisors, the Quality Assurance Physician or the
Responsible Physician. Annual PPD testing is required for all
individuals without contraindications who are on the Health Care
Provider Clinical Protocol (HCP).

**5.0 [HCW'S (NON BNL EMPLOYEES)]{.underline}**

Non-BNL employees who have direct contact with research subjects will
provide documentation to OMC verifying that TB screening was done at
another facility. If that is not possible, the screening will be done
through OMC.

**6.0 [ALL GCRC HCW'S]{.underline}**

6.1. Complete required skin testing at a minimum annually, or more
frequently based on the risk assessment.

6.2. Report incidents of occupational exposure to the supervisory chain
and complete appropriate follow-up with Occupational Medical Clinic.

**7.0** **[SIGNS/SYMPTOMS OF TB]{.underline}**

7\. 1. Persistent cough (\>2 weeks duration) along with:

a\. Weight loss

b\. Night sweats

c\. Bloody sputum

d\. Anorexia

e\. Fever

**8.0 [HEALTH CARE WORKER (HCW) RESPONSIBILITIES]{.underline}**

8.1. Seek medical evaluation if symptoms develop.

8.2. Notify OMC if PPD test converts

8.3. Notify OMC if diagnosed with Active TB

8.4. Notify OMC if immunocompromised and at risk of contracting
infection/developing disease so that work assignment can be modified. .

**9.0 [RESTRICTIONS FOR HCW'S WITH ACTIVE TB]{.underline}**

HCW's with pulmonary or laryngeal TB will be excluded from work until
cleared by OMC or private physician or clinic as being non-infectious.

.

**10.0** **[PARTICIPANT DETECTION/TREATMENT AND
TRANSPORTATION]{.underline}**

Any subject/participant with symptomology consistent with pulmonary TB
shall immediately be referred to his/her private physician or to a local
hospital or clinic. Also, the Suffolk County Department of Health shall
be called. While awaiting transfer for offsite evaluation, the subject
will be encouraged to cover his/her mouth with a surgical mask N-95 when
coughing/sneezing. The individual will be asked to wait in a low traffic
area at OMC, preferably the recuperation room behind the Treatment Room.
When referral and transportation is arranged, the employee is
transported wearing a surgical mask.

**11.0 POTENTIAL OCCUPATION EXPOSURE TO TB**

11.1. Cough inducing procedures

a\. Bronchoscopy

b\. Endotracheal Intubation

c\. Suctioning with mechanical ventilation

d\. Sputum induction/aerosol treatments

11.2 Open abscess irrigation

11.3. Autopsy

11.4. Close contact with infectious subjects/participants

11.5. Waiting Areas where subjects/participants with suspected TB are
located

**12.0 [RECORDS]{.underline}**

The GCRC shall maintain the records for the subjects in a secure manner.
The contents will not be disclosed or reported to any person within or
outside the workplace without the subject's express written consent
except as required by law. All OMC policies, procedures and records are
kept on file at the OMC.

**13.0 [DEFINITIONS]{.underline}**

[Acid-Fast Bacilli]{.underline} (AFB)-Bacteria that retain certain dyes
even when washed with an acid solution. Most acid-fast organisms are
mycobacteria. When seen on a stained smear of sputum or other clinical
specimen, a diagnosis of TB should be considered: however, the diagnosis
is not confirmed until a culture is grown and identified as [M.
tuberculosis]{.underline}.

[Aerosolization]{.underline}-In TB, it refers to the infectious droplet
nuclei that are expelled from a person which can be transmitted to other
people.

[HEPA]{.underline}(High Efficiency Particulate Air) Filter-Specialized
filter that is capable of removing 99.97% of particles 0.3 microns in
diameter. It may be of assistance in control of TB transmission.

[Infection]{.underline}-The condition in which organisms capable of
causing disease (e.g., [M. tuberculosis]{.underline}) multiply within
the body and cause a response from the host's immune defenses. Infection
may not lead to clinical disease.

[Infectious]{.underline}-Capable of causing infection. In TB, a person
is infectious only if he/she has clinically active TB. TB patients whose
sputum is AFB smear positive are often infectious.

[Positive PPD Reaction]{.underline}-A reaction to the purified protein
derivative (PPD) test that suggests the individual tested is infected
with the tubercle bacilli. Determination of the reaction is largely
dependent on interpretation by the person evaluating the test, given the
patient's or HCW's medical history and risk factors.

[Tuberculosis]{.underline}-a Clinically apparent active disease process
caused by [Mycobacterium tuberculosis]{.underline} complex.

[Tuberculosis Infection]{.underline}-A condition in which living
tubercle bacilli are present in the body, without producing clinically
active disease. Although the infected individual has a positive
tuberculin reaction, he/she has no symptoms related to the infection and
is not infectious. However, the infected individual remains at lifelong
risk of developing disease unless preventive therapy is given

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.