OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.

April 22, 1996

The Honorable Frank Mascara
U.S. House of Representatives
Washington, D.C. 20515

Dear Congressman Mascara:

This letter is in response to your letter of November 28, 1995, on behalf of your constituent, Mr. Anthony M. Lombardi, President and Chief Executive Officer of the Mon-Vale Health Resources, Inc. Mr. Lombardi raised several issues related to an inspection conducted at one of his facilities by the Occupational Safety and Health Administration (OSHA). After reading the letter sent to you by Mr. Lombardi we can certainly understand his concern. In order to answer his letter we will provide a rationale or explanation for each point as it was raised.

According to Mr. Lombardi, the inspection was initiated as an unannounced inspection from an anonymous call on unsafe conditions in the hospital laundry. First, Section 17(f) of the Occupational Safety and Health Act (OSH Act) makes clear that compliance inspections are to be unannounced. Second, the inspection was in fact prompted not by an anonymous complaint, but by a signed employee complaint which met the formality requirements of Section 8(f) of the OSH Act. The Act requires that an inspection be performed in response to such complaints. In comparison, anonymous complaints are usually handled by mail or telephone.

Mr. Lombardi raises the point that the OSHA inspector did not confine the visit to the area of the complaint (laundry), but expanded it to include an investigation of the safety program for exposure to tuberculosis (TB). The Area Office responsible for the inspection informed us that one of the complaint items specifically dealt with training issues related to workplace exposure to TB and bloodborne pathogens. Thus, the inspection corresponded to the items referenced in the complaint.

For your information, since the early 1990's, the agency has received numerous complaints and requests for information on our policy regarding occupational TB exposure. In response to this, OSHA issued a compliance memorandum for enforcement action on workplace TB exposure in October of 1993. That compliance memorandum was based upon the 1990 TB guidelines issued by the Centers for Disease Control and Prevention (CDC). In addition to assuring consistent, agency wide enforcement action for TB exposure, the policy provided the regulated community with clear information regarding OSHA's requirements and rationale on TB enforcement. Under this policy OSHA inspections for occupational exposure to TB are conducted in response to employee complaints and as part of all industrial hygiene inspections conducted in workplaces that the CDC has identified as having a greater incidence of TB infection than the general population. These areas include healthcare facilities (hospitals), correctional facilities, homeless shelters, long-term care facilities, and drug treatment centers. Thus even if the complaint had not addressed TB exposure, it would have been covered under our enforcement policy.

Mr. Lombardi raised several points on the issue of respirator requirements. At the time of the inspection, based upon the best available information on worker protection, OSHA required exposed employees to wear high efficiency particulate air (HEPA) respirators. At the time of the 1993 compliance memorandum there were no certified respirators available for biological agents. Respirators are certified by the National Institute for Occupational Safety and Health (NIOSH). Thus, the selection of a respirator for protection against TB exposure had to rely on a comparable dust-TB approximation due to the size of the TB bacilli (1 - 5 microns). The only approved particulate respirators that could achieve the required filter efficiency and provide protection against a TB droplet nuclei were those with HEPA filters.

Mr. Lombardi is not correct when he states that recently "OSHA concluded HEPA masks were no more effective than the surgical masks we previously used." In response to the healthcare industry's concerns, on July 10, 1995, NIOSH revised its particulate respirator certification criteria under 42 CFR Part 84 Subpart K to include certification of respirators for TB exposure. OSHA will accept the use of the newly certified respirators, some of which are slightly less efficient than the HEPA respirators. Under the new certification criteria, respirators classified as either Type 100, 99, or 95 would be acceptable for worker protection against exposure to TB. The Type 95 which is commercially available and is considerably less expensive than a HEPA respirator is the minimally acceptable level of respiratory protection. The masks being worn at the Mon-Vale facility at the time of the inspection were surgical masks. Surgical masks are not certified by NIOSH as respiratory protection and remain unacceptable under the CDC's 1994 guidelines, which OSHA follows in its enforcement policy.

OSHA's standard for respiratory protection requires that employees be trained in the use of respirators and that they be fit tested. Training of employees is to assure that the worker knows the types of exposure the respirator provides protection against, as well as how to wear, check, and maintain the respirator. The fit testing requirement is to assure that the selected mask does indeed fit the wearer. Mr. Lombardi indicated in his letter that he had to fit test 280 employees. It would appear from this number that the hospital chose to conduct fit testing for most of the workers in the hospital. The OSHA compliance officer, on the other hand, identified only 28 individuals whose duties would have required them to wear respirators. This is 252 people less than identified by Mr. Lombardi. OSHA, as a matter of policy, requires only three groups of workers to wear a respirator. These include:

1. Employees that enter areas occupied by a confirmed or suspect TB Patient;

2. Employees that performing high risk procedures on an individual with suspected or confirmed TB; and

3. When emergency medical response personnel or others transport, in a closed vehicle, an individual with suspected or confirmed TB.

No other workers under our TB enforcement policy are required to wear respiratory protection and receive fit tests.

Mr. Lombardi also mentioned the cost of the fit test kit, which does seem rather expensive. Under our fit testing requirements, we specify that fit testing must be either qualitative or quantitative and that the employer should refer to the fit testing recommendation of the manufacturer for the respirator. The quantitative fit test is the more expensive of the two. There are also a number of acceptable qualitative fit test procedures available on the market. Different manufacturers recommend different procedures, some of which are more expensive than others. OSHA, as an agency cannot recommend one manufacturer or supplier over another. The facility was apprised of these facts during the inspection.

In his letter, Mr. Lombardi raises the point of a respirator training film and his costs associated with having all the workers watch it. While the agency does require workers to be trained we do not specify how the training is to be conducted. The training requirements would have been no more different than any current training done for any workers in the facility currently wearing a respirator. As previously mentioned, the inspection identified only 28 individuals that would need to wear respirators and thus receive training. If any workers had been previously trained, the hospital should not have incurred any additional costs.

We hope that this information provides assistance to your constituent and clarifies his concerns. Should you or Mr. Lombardi require further information please contact Richard Fairfax in OSHA's Office of Health Compliance Assistance at (202) 219-8036. Thank you for your interest in worker health and safety.


Joseph A. Dear
Assistant Secretary

November 28, 1995.

Ms. Geri D. Palast
Asst. Sec. For Cong. Affairs
Frances Perkins Building
Room S-2018
3rd and Constitution Ave., N.W.
Washington, D.C. 20210

Dear Ms. Palast:

Enclosed please find a copy of a letter I have received from Anthony M. Lombardi, President and Chief Executive Officer of the Mon-Vale Health Resources, Inc., expressing concern about an OSHA action taken against his hospital.

I certainly share his displeasure that the hospital spent nearly $7,000 only to find out that the original mask hospital workers were using were safe and effective. Moreover, I worry, as he does, that such decisions needlessly add to rising health care costs. As a result, I would greatly appreciate it if you could ask the appropriate Department officials to explain what happened in this situation.

I want to thank you in advance for your cooperation and assistance and look forward to a prompt reply.

Very truly yours,

Frank Mascara
Member of Congress

November 20, 1995

Representative Frank R Mascara
1531 Longworth Building
Washington, D.C. 20515-3820

Dear Frank:

In their pursuit for a Contract On America the Republicans are slashing Medicare and Medicaid disproportionately not solely to balance the budget, but also to compensate for hospitals' "inefficiency."

Let me illustrate how inefficient we are as a hospital and how efficient OSHA is as an agency of the government.

In July 1994 we received an unannounced visit from OSHA in response to an anonymous call of unsafe conditions in our hospital laundry.

The OSHA inspector did not confine her visit to the laundry but also conducted an investigation into our employee safety procedures for caring for patients suffering from Tuberculosis.

The inspector concluded we were supplying our employees with the wrong face mask to insure isolation and insisted the correct face mask to use was one which is called a HEPA mask. We challenged the inspector based upon a written report which indicated nonconclusive evidence that HEPA would become the required mask to use.

OSHA assessed us a $1,300 fine for not using HEPA masks. We personally appealed. The fine was reduced to $700 and we were ordered to use HEPA masks.

A total of 280 employees who would have occupational exposure to TB now had to be fitted with HEPA masks. The Fit Testing Kit and Supplies cost us $550.

While fitting all 280 employees, each was also required to watch an educational film on the product and how to avoid exposure. This took 210 hours at $17.00 an hour in wages or a cost of $3,570.

A one-year supply of HEPA masks cost us $3,238 vs. a one-year supply of the masks we were previously using which cost us $1,349; additional cost to us $1,889.

Last month OSHA concluded HEPA masks were no more effective than the masks we previously used.

That we were right is not important. That an OSHA requirement based on non-conclusive evidence forced us to incur additional costs in excess of $6,700 is important. Based upon our current cost per day we could have rendered one day of care to ten Medicare patients for that amount of money.

Multiply this situation across the country, as I am sure our situation is not unique and it's not an exaggeration that incidents such as this are adding billions of dollars to the cost of health care.

By the way the unsafe conditions for which the inspector was called were found to be non-existent by the inspector but we had to suffer this frivolous inspection and outcome.

Thank you for taking the time to read this.

Very truly yours,