Standard Interpretations - Table of Contents Standard Interpretations - (Archived) Table of Contents
• Standard Number: 1910.1030
• Status: Archived

Archive Notice - OSHA Archive

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

July 10, 1995

Gary L. Hein, President
Lincoln Diagnostics, Inc.
P.O. Box 1128
Decatur, IL 62525

Dear Mr Hein:

Thank you your letter dated June 22, 1995, concerning allergen testing procedures. Your letter addresses several important points relevant to 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens. Each will be addressed separately.

1. Applicability of 29 CFR 1910.1030 Bloodborne Pathogens. Under paragraph 5(a)(1) of the OSH Act, the employer is responsible to ensure a safe and healthful workplace for all employees. More specifically, the Occupational Exposure to Bloodborne Pathogens standard applies where "... occupational exposure to blood or other potentially infectious materials...can be reasonably anticipated." (p. 64175) OSHA has not attempted to list all the occupations where such exposures have the potential to occur. This listing comprises a portion of the employer's Exposure Control Plan.

As the employer specified in your letter, the allergist is responsible for the provisions of the standard. Procedures performed by the employees in this worksite do include the reasonable anticipation of contact with blood and other potentially infectious materials. This constitutes the definition of "occupational exposure" and OSHA therefore believes the standard is applicable to allergists and their employees who perform allergen test procedures.

2. Feasibility of engineering controls. One of the greatest hazards to workers is from needles and other sharp objects contaminated with blood or other potentially infectious, materials. Of the 25 cases of HIV seroconversion reported in the standard's health effects section, 15 were associated with needlestick injuries. The chance of becoming infected after a single needlestick from a patient infected with Hepatitis B ranges up to 30%. The intent of the Bloodborne Pathogens standard is to minimize or eliminate reasonably anticipated skin and other contacts with blood or other potentially infectious materials. Therefore, OSHA requires the handling of contaminated needles and sharps be dealt with accordingly.

The needles which are used to inject extracts of various allergens either subcutaneously or intradermally are considered to be "contaminated sharps"; that is, they would be reasonably anticipated to involve the presence of blood or other potentially infectious material. The presence of non-visible body fluids would also constitute "contamination."

Employee contact with contaminated articles, specifically the needle or other instrument used for allergen testing, would need to be eliminated or minimized. If contact is required by a specific medical procedure or if no alternative is feasible, engineering controls (i.e., mechanical devices), or work practice controls (i.e., one-handed technique), must be employed. Engineering and work practice controls would need to be evaluated by the employer to facilitate the elimination or minimization of the risk. If engineering and work practice controls do not eliminate or minimize the occupational exposure potential, personal protective equipment shall also be used.

Further, the standard requires each employer to establish an exposure control plan "designed to eliminate or minimize employee exposure." The exposure determination shall be made without regard to the use of personal protective equipment. Clearly, the "prick and wipe" or "scratch and wipe" procedure described in your letter would merit attention from the employer to minimize occupational exposure. If contact with the contaminated needle must be practiced, it must be accomplished through the use of engineering or work practice controls. The exposure control plan must include a provision for the use of these controls in the specific circumstance.

3. Endorsement of products. Your implicit request for OSHA to review and comment on your product, a disposable multi- test skin testing device, is beyond the purview of this agency. OSHA does not review or endorse products as you have requested. The final determination of compliance must take into account all factors pertaining to the use of such devices at a particular worksite. This must include an evaluation through direct observation of employee work practices as well as an evaluation of the equipment or devices alone.

4. Recommendation for specific practice methodologies. Most recent OSHA standards are written as performance rules; they state a general objective to be achieved without stating requirements for accomplishing that goal. OSHA has used this same general approach in the Bloodborne Pathogens standard. Instead of stating precisely which employees should be provided gloves or goggles, or which need more extensive protection, we have essentially required employees be protected through a combination of work practices, engineering controls and personal protective equipment to the extent such protection is necessary dependent upon the extent and type of exposure. This approach requires judgement on the part of employers as to which employees are exposed, how extensively they are exposed, and what protection is necessary.

You expressed the belief that the standard prohibits the performance of the "prick and wipe" or "scratch and wipe" technique of allergy testing. There is nothing in the standard that would prohibit the performance of any medical procedure. The standard simply requires all human blood and certain body fluids be treated as if they were known to be infectious for HIV and HBV; employees with occupational exposure be provided with the protections of the standard, including the implementation of engineering and work practice controls as well as the wearing of appropriate personal protective equipment such as gloves; and, contaminated sharps be appropriately containerized and labeled. The final OSHA rule does not dictate professional practice. This is the responsibility of the profession.

I hope this information is helpful to you. If you have any further questions feel free to contact Elise Handelman, Acting Director, Office of Occupational Health Nursing at (202) 219-7056.

Sincerely,



Charles Adkins, CIH
Director
Directorate of Technical Support




June 22, 1995

Mr. Joseph A. Dear
Assistant Secretary For Occupational
Safety And Health
Department of Labor
OSHA
200 Constitution Avenue, N.W.
Washington, D.C. 20210

Dear Mr. Dear:

There is a high risk procedure that endangers the health of nurse-technicians employed by physicians who use it. OSHA may not be aware of this procedure because it is used by a relatively small sub-specialty group of physicians, those practicing allergy. It does, however, involve a large number of patients and nurse-technicians. It is commonly referred to as "prick and wipe" or "scratch and wipe." The nurse or technician employs an instrument with a sharp point, often a needle, to introduce test substances into the skin by piercing or scratching the skin through a drop of allergenic extract or control solution placed on the skin. Only one needle, or instrument, is used per patient, requiring the user to wipe the piercing tip carefully between each test site so that carryover of one allergenic extract to the test site of another is prevented. Frequently bleeding occurs at one or more test sites. Since an average number of tests per patient ranges between fifty and sixty, users have many opportunities to inadvertently prick their fingers with an instrument possibly carrying residual blood from the patient. It would not be uncommon for a nurse-technician to test ten or more patients per day during allergy season. This translates to more than five hundred chances per day per nurse-technician to be infected with blood borne diseases.

I have approached Dr. Donald W. Aaronson, Executive Vice President, Joint Council of Allergy and Immunology, regarding this problem and enclose for your review copies of my correspondence and his response. Unfortunately, Dr. Aaronson is not aware of the fact that the "prick and wipe" and "scratch and wipe" procedures are widely used today. He, and many other prestigious practices, as well as teaching institutions, use disposable products and apparently find it hard to believe that others do not follow the same high standards to protect their employees. We did, as you will see, write Dr. Aaronson with an ulterior motive. However, there are today three other disposable devices that are used routinely to administer skin tests, all providing clinical results equal to or better than the "prick and wipe" or "scratch and wipe." In addition, all of these devices afford protection for users.

I am enclosing a reprint of an article entitled "Evaluation of the Multi-Test device for immediate hypersensitivity skin testing" that appeared in the prestigious publication, THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, December 1992. This is the first published finding on skin testing that, to my knowledge, makes reference to user safety associated with procedures. Please see the last paragraph, left column, Page 984.

This morning I had blood drawn as part of my annual physical examination. The nurse informed me that OSHA regulations prevented her from replacing a protective needle cap over the needle after use and before disposal because of the risk associated with the procedure. The risks inherent to the "prick and wipe" or "scratch and wipe" are vastly greater than those associated with the referenced hypodermic needle.

I appreciate your consideration of this matter and will look forward to your response.

Sincerely,



GARY L. HEIN
President




March 26, 1993

Donald W. Aaronson, M.D.
9301 Golf Road
Suite 301
Des Plaines, Illinois 60016

Dear Dr. Aaronson:

I am enclosing a photocopy of a statement that appeared in Briefs, Wall Street Journal, Midwest Edition, March 24, 1993. If politicians are taking aim at the safety of hypodermic needles, it seems reasonable that the issue of safety associated with certain skin testing techniques may also be raised. I have been told than C. D. C. personnel have discussed the safety factor related to use of a single scarifier to administer multiple skin tests on the same patient, with the point or points being wiped off between test sites. This procedure generally affords the user forty to one hundred chances per patient to accidentally prick his or her skin with a contaminated device.

I don't know how aggressive OSHA has been with practicing physicians, but if its history with dentists is an indicator, then physicians may face some unwanted intervention into his or her practice. As a physician-lawyer, you may not only look at the safety issue, but also the possible liability factor which may be very real.

Because of your position of influence, I write to you with an ulterior motive. As you know, we manufacture the Multi-Test device that we feel is probably the safest method for users to administer skin tests. Enclosed is a reprint from the December 1992 issue of JACI. I call your attention to the highlighted language on Page 984.

Sincerely,



GARY L. HEIN
President




April 5, 1993

Gary L. Hein, President
Lincoln Diagnostics, Inc.
P.O. Box 1128
Decatur, IL 62525

Dear Mr. Hein:

I received your letter regarding the multi-test and the risks of single scarifier. While I assume it is possible that some physicians may be using scarifiers for skin testing, I think it would be very rare today for that to be occurring.

The JCAI, on which I serve as Executive Vice President, is not specifically in the business of telling physicians what is or is not proper from perspectives of advertising a single company's method. We have tried to provide proper guidance to our physicians as to how they should make decisions on the way they do things in their practices. But they make the decisions, not us.

Thank you very much for your input.

Sincerely,



Donald W. Aaronson, M.D.
Executive Vice President




April 13, 1993

Donald W. Aaronson, M.D.
9301 Golf Road
Suite 301
Des Plaines, Illinois 60016

Dear Dr. Aaronson:

Thank you for your April 5 letter. We understand and appreciate the position that the Joint Council cannot advocate the use of one company's method over that of another, assuming both are acceptable. We do, however, like to point out valid advantages for our product to those who are in a position to influence the thinking of others.

We would like to think, as you do, regarding the number of physicians currently using one scarifying device per patient, but unfortunately that number is surprisingly large and significant. I am sure you will agree that wiping the tip of a scarifier between test sites is a high risk procedure for the user. A physician who knows, or should have known, that there are safer methods might encounter a difficult situation should an employee become infected with a blood borne disease transmitted by inadvertent pricking of the skin. The additional factor for consideration is, as you know, antigen carryover between test sites.

Again, thank you for your prompt response to my March 26 letter.

Sincerely,



GARY L. HEIN
President

  (For Evaluation of the Multi-Test device for immediate hypersensitivity
                       skin testing, see printed copy)

Archive Notice - OSHA Archive

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.


Standard Interpretations - Table of Contents Standard Interpretations - (Archived) Table of Contents