January 31, 2005

Centers for Disease Control and Prevention
Division of Tuberculosis Elimination
1600 Clifton Road NE
Mailstop E10
Atlanta, GA 30333

Re: Public Comment on Draft Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005

The Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 draft is a comprehensive and well organized document with a methodical approach to screening and risk classifications. The American Association of Occupational Health Nurses, Inc. (AAOHN) commends the Centers for Disease Control and Prevention (CDC) for undertaking the task of updating the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, 1994.

In response to the Occupational Safety and Health Administration’s (OSHA) tuberculosis and respirator fit-testing documents, the Association:

• Used CDC’s "1994, risk assessment" to offer practical, effective-targeted-solutions to identify fit-testing specifics for healthcare workers (HCW) (2002);

• Suggested addressing the issue of respirator protection for "all airborne infectious diseases;"

• Suggested addressing the issue of guidelines for respirator needs by industry segment (vs. the one-size fits all approach); and

• Suggested fit testing when hired and performing an annual health survey/questionnaire to determine medical and/or physical changes that affect the fit of the respirator (2003).

Although the Association was not in complete agreement with the OSHA revisions to the respiratory protection standards (29 CFR Part 1910), the Association commended OSHA for raising the issues of occupational exposure to tuberculosis (TB) and stressing the importance of the respirator for protection. However, OSHA fell short by addressing respirator fit testing for only TB. There are other aerosol infectious agents of equal or greater concern for potential exposure. The CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 also falls short for: 1) addressing only TB and 2) skirting around the respirator fit testing by suggesting a "periodic" fit testing after the initial fit test during training. Guidelines for all aerosol infection agents and with definitive direction regarding the frequency of fit testing after the initial fit testing during training will provide greater protection and clarity for HCWs.

Specific Comments:

After reviewing the CDC draft document, the Association has the following recommendations:

• We support the inclusion of the Q&A section, which should be a continuous part of CDC’s information process, such as Health & Human Service (HHS), Health Insurance Portability and Accountability Act of 1996 (HIPAA), Q&A.

• Page 21, B.3, 6^th bullet: Should also include sneezing since tuberculosis is carried in airborne particles per page 19.

• Page 49, Respiratory Protection, 1^st bullet: Delete the "or".

• Page 50, "Patient rooms": Suggest adding, "If AII room is not available…" as you did on page 49, "Setting."

• Table 5 (starts on page 49 and continues to page 55): Suggest repeat header when table moves to next page. Makes it easier to read and follow. Some of the header is repeated on page 56 for another aspect; header needs to repeat on pages 57-59; and 60-61.

• Page 84, F.1.2, 1^st sentence: Nurses should be included along with physicians, trainees, and students.

• Page 85, Table 6, 3^rd bullet: Should not only include indications for initiation of AII room, but also procedures/principles to ensure infection control measures are not compromised.

• Page 90, G.4.4: We support the statement about staggering annual follow-up screening. This could include tuberculin skin test (TST), symptom screening, OSHA questionnaire, fit-testing based on risk assessment, etc.

• Page 111, 7^th bullet: Should include facial sizes and shapes as well as facial hair.

• Page 122, A.2.2, 2^nd sentence: Suggest changing from 27G only to 27G or finer.

• Page 123, A.3.3: While it is stated that alternative TST reading methods are described, the resources are written in very technical and confusing language. Therefore, suggest clarification and description of other methods, i.e., pen method.

• Page 130, "Initial training….", 1^st and 2^nd bullet: Recommend omitting training hours. Suggest including only recommended training content.

• Page 132, IV, last check: For clarification and based on MMWR October 25, 2002/51(RR16); 1-44, suggest changing to "appropriate hand hygiene after TST administration" which includes handwashing and antiseptic handwash.

• Page 132, II Syringe filled… 6^th statement reads "twists needle onto syringe to ensure tight fit". This implies the use of a separate needle and syringe, which does not comply, with the Needlestick Safety Act of 2000.

• Page 193, 194, and 195: Suggest using Licensed Health Care Provider (LHCP), which includes physician, nurse practitioner, physician assistant or registered nurse.

• Page 193, Table S4-2: Suggest using "Licensed Health Care Provider" in place of "Physician" because in 18 states, the registered nurse can make respiratory determination.

• Page 194 and 195, Table S4-3: Suggest using "Licensed Health Care Provider" in place of "Physician" because in some states a nurse practitioner may perform the medical clearance.

• There were numerous "word-space" typos through out the document.

The TB risk assessment and worksheet provides factors to determine site-specific indicators to establish need and frequency for TB screening and fit testing. Therefore, using the risk assessment would aid the site with 1-case per year and 700 employees or the site with 10-20 cases per year and 1500 employees. The risk assessment takes work environment differences into consideration, which OSHA failed to do.

The document recommends (page 188) "initial and periodic (cyclic) fit-testing (based on risk-assessment for the setting) in accordance with applicable regulations", which refers to the OSHA regulation (29 CFR 1910.134). The document also states that face-seal leakage is the weak link and can "compromise the ability of particulate respirators to protect HCWs from airborne materials" (page 187). This implies the need for scheduled respirator fit testing (cyclic or annually). Then, on page 192, it states that well-designed respirators will probably achieve fit without fit testing but nevertheless recommends initial and periodic fit testing. This inconsistency creates a level of uncertainty and confusion among HCWs and places the efficacy of the guidelines at risk. Therefore, clarity is paramount.

AAOHN, as an advocate for the occupational and environmental health nurse (OHN) and safety and health in the workplace, conducted a HCW respirator fit-testing compliance survey in 2004. The survey indicated that 53 percent of respondents comply with CDC standards and 40 percent comply with OSHA standards. Therefore, the need for document consistency between agencies is obvious. The Association suggests the two agencies collaborate and agree on appropriate standards and guidelines that would provide for the health and safety of HCWs and clients, for whom they provide care, satisfying the purpose of each agency (protecting the health and safety of people).

The Association appreciates the opportunity to provide comments and recommendation to the CDC on the draft Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Setting, 2005. As always, we will continue to lend our input and assistance to governmental agencies to facilitate safe and healthful workplaces and communities.

Sincerely,

Susan A. Randolph, MSN, RN, COHN-S, FAAOHN
President

cc: AAOHN Board of Directors
     Ann Cox, Executive Director