September 20, 1995

The Honorable Michael N. Castle
U.S. House of Representatives
201 No. Walnut Street
Suite 107
Wilmington, Delaware 19801

Dear Congressman Castle:

This letter is in response to your letter of August 7, on behalf of your constituent, Mr. E. Ray Quillen, regarding the implementation of the new Occupational Safety and Health Administration's (OSHA) tuberculosis (TB) regulations in October of 1995.

A proposed OSHA standard for Occupational Exposure to TB has been tentatively scheduled for publication in the federal register during the second quarter of fiscal year 1996. This is a proposed standard which, once published, will be open for a 90 day public comment period. There are no plans to release a final TB standard in October of 1995. On October 8, 1993, OSHA issued a compliance memorandum for occupational exposure to TB (enclosed). This memorandum established agency wide policy for compliance and enforcement procedures for inspections involving occupational exposure to TB. This compliance memorandum is based on the 1990 Centers for Disease Control and Prevention (CDC) Guidelines for controlling TB exposure. OSHA is in the process of updating this memorandum with a compliance directive that is based upon the newer 1994 CDC Guidelines.

[This document was edited on 8/18/99 to strike information that no longer reflects current OSHA policy.]

The CDC and the CDC recommendations are the accepted authorities for infection control practices. The compliance procedures outlined in the October 8 memorandum emphasize CDC's specific recommendations including a hierarchy of controls (e.g., early identification, isolation, medical surveillance, personal protective equipment, and so forth). These compliance procedures are also consistent with the agency's traditional hierarchy of controls and "good industrial hygiene practice" which dictate that engineering controls be used whenever possible to eliminate and reduce the hazard at its source.

Mr. Quillen indicated in his letter that their normal procedure is to discharge a patient with TB to the hospital upon detection. This is an acceptable procedure. Under both the 1990 and 1994 CDC Guidelines the agency would expect that a facility that is not designed to treat TB patients (such as Mr. Quillen's) have procedures in place for the early evaluation and detection of patients with suspect TB. Once a suspect patient has been identified, procedures should be in place for the rapid transfer of the patient to a suitable facility designed to treat such patients. Mr. Quillen appears to be meeting these obligations.

Concerning respiratory protection, the compliance memorandum specifies that workers wear suitable approved particulate respirators under the circumstances listed below. Approved respirators include those respirators certified by the National Institute for Occupational Safety and Health (NIOSH), and include Types 100, 99, 95, and high efficiency particulate (HEPA) respirators.

1. When entering areas occupied by a confirmed or suspect TB patient.

2. When performing high risk procedures on an individual with suspect or confirmed TB,and

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

If, in Mr. Quillen's facility, staff members were to enter an area occupied by a suspect patient who was waiting for transport to another facility the agency would expect those employees to wear an approved particulate respirator for TB. Also if staff members were involved with transporting suspect TB patients, they would be expected to wear appropriate approved respiratory protection. The agency would not expect isolation rooms to be installed, nor would we expect everyone in the facility to wear HEPA respirators.

Concerning the penalty issue raised, a willful violation can have a maximum penalty of $70,000; however, these violations are only applied to those companies that display a blatant disregard for their responsibilities under the Occupational Safety and Health Act 1970 (OSH Act). Most violations related to TB have been classified as serious. The maximum penalty allowed for a serious violation currently is $7000. Realistically most serious violation penalties do not even approach that amount. During fiscal year 1994, the average assessed penalty for a serious violation throughout OSHA was approximately $780.00.

We have spoken with Mr. Randall Hair, the project director for OSHA's 7(c)(1) consultation program in Delaware, regarding Mr. Quillen's concerns. Mr. Hair has indicated that he will be trying to reach Mr. Quillen by telephone to further discuss the application of the OSHA guidelines to his workplace.

We hope that this information provides assistance to your constituent and clarifies his concerns about excess government regulations. Should you or Mr. Quillen 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.

Sincerely,



Joseph A. Dear
Assistant Secretary



August 7, 1995

The Honorable Robert B. Reich, Secretary
Department of Labor
Frances Perkins Building
Third and Constitution Avenue, NW
Washington, DC 20210

Dear Secretary Reich:

Recently, I received the attached letter from a constituent, Mr. E. Ray Quillen, concerning the implementation of new OSHA Tuberculosis Control Regulations in October of 1995.

As you can see from the letter, Mr. Quillen is the Administrator for the Courtland Manor, Inc. Nursing and Convalescent Home located in Dover, Delaware. Mr. Quillen is extremely concerned about complying with the anticipated new regulations for Tuberculosis and he indicates that his business would be caught in a catch-22 if these new regulations are implemented.

I would appreciate if you could review the concerns Mr. Quillen has raised and respond to me as soon as possible. Since this new regulation is suppose to be implemented in October of this year, it is very important that this issue be addressed promptly to avoid any violations.

Thank you in advance for your help and cooperation with this request. If you have any questions, please feel free to contact me or my district director Jeff Dayton directly. Also, please address all correspondence to Jeff Dayton, District Director, 201 N. Walnut Street, Suite 107, Wilmington, DE 19801.

Sincerely,



Michael N. Castle



July 16, 1995

The Honorable Michael Castle
Frear Federal Bldg.
Dover, De. 19904

Re: OSHA Tuberculosis Control Regulations

Dear Representative Castle,

I am writing to express my concern over the implementation, in October 1995, of the new OSHA Tuberculosis Control Regulations. I have discussed my T.B. Control Program with the OSHA Consultion Branch to be sure my plans will meet requirements. I was very surprised to learn that the nursing home industry is caught in an extreme Catch-22. Most nursing homes do not have the "air control" engineering required for housing patients with active T.B. The normal procedure is to discharge a patient with T.B. to the hospital (isolations rooms with air control are available there) upon detection. I have been told that this is unacceptable as "exposure" would all ready have occurred and that we would be guilty of a "willful" violation. Since "exposure" occurs before we could know of the presence of the disease, the only way to avoid a willful violation is to have every room meet T.B. standards. Needless to say this economically, if not physically, impossible to accomplish. Likewise, every staff-member would have to continually wear HEPA respirators to avoid violation of-the standard (to prevent possible exposure).

While this sounds like an over reaction on my part and just another false anecdotal story, it isn't. I gave the OSHA representative the following factual data:

A. No active T.B. cases or positive P.P.D. conversions in the facility for 15 years.

B. Each employee and patient screened for T.B. upon hire/admission.

C. Each employee screened annually for T.B.

D. In Kent County (the source of most staff and patients), there were 10 new cases of T.B. for 1990, 1991, 1992, 1993 combined, for an incidence rate of .06 cases per 1,000 population.

E. Contractual arrangements are in place with the local hospital to immediately transfer the patient even if "presumed" positive for active disease with return to the facility only after adequate therapy (per CDC guidelines).

The exact statement by the OSHA Representative was: "You must fully comply with the regulation including engineering controls or you would face willful violation sanctions if an active case occurs." The representative specifically stated that upon detection, exposure has all ready occurred and that a violation exists. In this sense, a violation can only be precluded if the individual is in an air controlled room and if the staff were wearing respirators before the illness is detected.

It is this type of ill informed, stringent application of regulations which is systematically paralyzing business in our country. If this isn't bad enough, the basis for the regulation may even be flawed. CDC or the DOL have determined that health care employees are at more risk of contracting T.B. than the general population. I wonder if this isn't because health care workers are continuously screened for T.B. (ie. more cases because of more monitoring vs. more cases associated with the work environment). This is a good example of a positive regulation gone bad before it's effective date by over zealous governmental employees.

If this regulation is implemented as told to me by OSHA, the long term care industry will be unable to comply in a manner which assures that they do not willfully violate it. We are being set up for failure. In an environment where everyone is calling for cost containment in health care, how does the Federal Government justify adding this cost to our operation when there can be no benefit shown? With no cases reported here (as far back as records can show) it should be evident that existing control measures are more than adequate and that additional measures (and cost) will provide no benefit to staff or patients. It will however increase cost substantially. Your help is needed to stop what I call "Regulatory Extortion." We are bullied into additional cost and compliance by the threat of a $70,000.00 willful violation punitive assessment.

Sincerely,



E. Ray Quillen, N.H.A.
Administrator