OSHA's Final TB Ruling
By David Willyard
New OSHA TB Standard
On October 17, 1997, OSHA released its proposed TB standard, based on CDC guidelines,
in the Federal Register. Following a lengthy comment and review period, OSHA is scheduled
to issue its final TB standard, or final ruling, by the end of this year. This standard
will take effect 90 days after it is published. In the meantime, OSHA is still inspecting
hospitals' TB programs in accordance with CPL2.016, OSHA's TB inspection criteria. This
discussion of the proposed OSHA standard concentrates on engineering controls,
specifically negative pressure and HEPA filtration systems. The ruling also deals with
frequency of skin testing, respiratory protection, and other areas of concern in
protecting healthcare workers from exposure to TB.
According to the proposed standard, many more facilities are at risk of occupational
exposure to TB than previously thought. Facilities that have not seen a confirmed TB case
in the past two years may still be required to comply with the standard. Unless a facility
can consistently transfer patients in less than five hours after the point of
identification in a suspect case, the employer may want to consider adding at least one
negative-pressure isolation room. Also, high-hazard procedures such as endoscopy, sputum
induction, and bronchoscopy, among others, must be conducted in isolation rooms or areas
with negative-pressure capabilities.
TB Engineering Controls
OSHA does not specify required ventilation methods for achieving negative pressure,
instead OHSA allows "any workable design" as long as the engineering controls
are capable of creating a negative-pressure isolation room. In other words, OSHA considers
engineered TB isolation rooms and HEPA (High-Efficiency Particulate Arrestance) filtration
devices, or HFDs, to be equivalent solutions, as long as they achieve the required
results. This is extremely good news, especially for budget-strapped healthcare facilities
as they can opt for the use of fixed or portable devices in lieu of much more costly
facility engineering solutions.
Designing and building a negative-pressure isolation room or converting an existing
patient room for this purpose can drive the cost to $55,000 or more. HFDs, which can be
fixed units that mount into the ceiling or onto a wall, or portable devices that can be
wheeled from room to room, generally cost $2,000 to $5,000. As a result, an increasing
number of healthcare facilities are choosing to use HFDs to achieve the six to 12 air
changes per hour (ACH) as recommended by the CDC. Portable HFDs are especially popular as
they can be used to convert quickly and economically a standard patient room into a TB
isolation room or treatment room and can be moved from room to room as needed.
Exhaust air from HFDs can be ducted through a side wall, ceiling plenum, or patient's
window in accordance with state and local regulations concerning environmental discharges.
Also included in the proposed regulation is use of a continuous monitoring device, backed
up by a monthly smoke-trail test to confirm the presence of negative pressure. HFDs must
also be maintained and inspected for filter loading and leakage every six months, whenever
filters are changed, and more often if necessary to maintain effectiveness.
When evaluating an HFD, the performance factors required for the specific application,
not just initial cost, should be considered. Operational airflow, filter efficiency,
security, ease of operation, overall quality, performance verification, manufacturer's
reputation, and total operating costs are all important considerations.
When considering the purchase of a HEPA filtration system, review the quality of the
materials and workmanship. Look at the installation and operating manuals if possible.
Request information about the manufacturer's product warranty. UL, CSA, or another
nationally recognized testing laboratory (NRTL) should approve the system. Also, determine
how long the manufacturer has been in business and ask for references from at least 10
health facilities using their equipment. Ask the appropriate individuals at the facilities
about performance, installation, maintenance, and energy consumption.
The concern for controlling TB in the healthcare community will continue to rise.
Failure to provide the necessary protection to healthcare workers, currently enforced
under OSHA's "general duty clause" has resulted in hospital fines ranging from
$5,000 to $150,000. Healthcare facilities must become proactive to control the risk of
infection to workers and patients alike.1 In-room HEPA filtration devices
provide an economical and efficient alternative for meeting national standards and
providing protection for healthcare workers, patients, and visitors. The flexibility of
these units appears to be endless in the attack on TB and other airborne pathogens. A
well-designed system is an important component of every healthcare facility's infection
David Willyard, vice president of Abatement Technologies, Inc., (Duluth, Ga), a
manufacturer of HEPA filtration devices. Abatement Technologies' HFDs are used by more
than 500 healthcare facilities throughout North America for controlling TB and other