OSHA Compliance: How Clean Needle Technique Falls Short in the US
by David Kailin
The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) delegated to the National Acupuncture Foundation (NAF) the task of generating guidelines for the acupuncture profession with respect to safety and disease transmission. There have been five editions of Clean Needle Technique Manual for Acupuncturists: Guidelines and standards for the clean and safe clinical practice of acupuncture (CNT), in several languages. I will critique the fifth and most recent edition (NAF, 2005). The Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) recommends CNT for preparation for the clean needle technique exam, which is required for NCCAOM certification. Some states also require the CNT course and CNT examination as qualifications for acupuncture licensure.
The CNT text claims to “integrate Occupational Safety and Health Administration (OSHA) codes and the latest information on communicable diseases” (p. vi). Yet it fails to provide sufficient, correct, and current guidance on basic federal OSHA regulatory requirements. Relying solely on CNT for guidance, acupuncturists will not obtain essential information needed for compliance with the federal OSHA Blood borne Pathogen Standard. Clinicians operating facilities with more than a very low risk of tuberculosis (TB) transmission are not given the guidance needed for compliance with the federal OSHA Respiratory Protection Standard. The authors of CNT (2005) explicitly acknowledged their duty to provide current information, yet the most recent dated citations are from 2002. Consider the following examples of how CNT falls short.
CNT does not correctly or fully identify the requirements of the Needle-stick Safety and Prevention Act of 2000 (NSPA), which went into effect in 2001. The NSPA requires an annual documented process of identifying, evaluating and selecting safer sharps (29CFR1910.1030 c 1 iv) with input from employees involved in direct patient care (29CFR1910.1030 c 1 v). The NSPA also requires the recording of contaminated needle-stick injuries in a log book (29CFR1910.1030 h 5 i) by employers otherwise required to log occupational injuries under 29CFR1904. The name of the injured employee should not appear in the log, but you must identify the type and brand of device, the work area where the accident happened, and the circumstances of the incident. CNT, which only cites the NSPA in two brief footnotes (pp. 29, 54), erroneously states that sharps injury logs must be kept by each sharps container, wrongly identifies the contents of the sharps injury log, and never mentions the process of identifying, evaluating and selecting safer sharps.
CNT does not effectively convey current standards for non-surgical hand hygiene, nor does it incorporate the use of alcohol-based hand rubs as advanced by the Centres for Disease Control and Prevention (CDC) in 2002 and approved by OSHA in 2003. In the absence of direct contact with blood or other potentially infectious material (OPIM), OSHA currently considers the use of alcohol-based hand rubs as equivalent to soap and water hand washing (OSHA, 2003).CNT only indicates that alcohol-based hand rubs are for use when no sink is available (pp. 22, 32), or as a secondary antiseptic for fingertips after an initial hand washing and prior to needling (p. 23).
CNT does not offer a satisfactory presentation of Additional Precautions that one should take with highly contagious patients. Under the heading of High-Risk Patients (p. 58), CNT states nothing more than “Under Universal Precautions, all patients should be treated the same.” Yet a careful reading of CNT uncovers advice to use antimicrobial hand hygiene products when treating immune-compromised patients (pp. 22, 36), and to use “a mask” when working with active TB cases (p. 52). By no means does this convey the extent of appropriate Additional Precautions against contact, droplet, and airborne transmission (CDC, 2002; Australian Government Department of Health and Aging, 2004). OSHA does not forbid (and sometimes requires) the use of Additional Precautions (e.g. 29CFR1910.134).
CNT mentions wearing a mask when working with active TB cases (p. 52), and recommends getting an annual (or semi-annual) purified protein derivative (PPD) test (p. 16). CNT briefly quotes the CDC’s advice to implement TB infection control programs (p. 17). But there is no identification of what kind of mask must be worn (an N95 respirator or better), and no information on initial medical evaluation and at least annual fit testing for a respirator. OSHA withdrew its proposed TB protection rules in 2003, and in their stead applied the general industry Respiratory Protection Standard (RPS) (29CFR1910.134). The need for a written RPS plan is based on a facility risk assessment. Even very low-risk facilities are well served by standard operating procedures in the event a suspected or known-active TB case is encountered.
Since 1991, the OSHA Blood borne Pathogen Standard has required that employers with employees at risk of occupational exposure to blood or OPIM develop an Exposure Control Plan. CNT’s explanation of the elements of an Exposure Control Plan (pp. 50-1) is remarkably inadequate. CNT does not list required work practice controls (29CFR1910.1030 d 2), such as prohibition of eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses in work areas with exposure risk. Personal protective equipment (PPE) must be removed before leaving the work area (29CFR1910.1030 d 3 vii), but CNT doesn’t mention that stipulation. The required components of annual employee blood borne pathogen training (29CFR1910.1030 g 2 vii) are not presented.
The deficiencies in CNT, of which the above are but a sample, stand out as liabilities for a broad array of stakeholders. Consider the various ways a scenario similar to this might play out: An acupuncturist becomes infected with an occupationally transmitted pathogen, one which would have been preventable had he/she been trained to practice in compliance with OSHA standards. His/her lawyer files suit against her acupuncture college, NAF, NCCAOM, CCAOM, and the state licensing board, seeking to hold each party accountable for reliance on CNT guidance and training, which the lawyer then portrays as sub-standard. Even in the absence of such a case, credibility and legitimacy are at stake now for these organizations. OSHA compliance and safe clinical practice are at stake for the acupuncture profession as a whole.
Members of the acupuncture profession have paid a tidy sum for CNT training. They might expect, and certainly deserve, competent safety guidance fully in line with OSHA standards. After years of CNT manuals that fall short of correctly and adequately conveying current federal OSHA blood borne pathogen safety requirements, it is time for a change in the participants, the process, and the product. Clinicians, students and educators seeking current and comprehensive explanation of federal regulations impacting CAM may refer to my recent text, Quality In Complementary & Alternative Medicine (Kailin 2006). To access federal OSHA regulations directly, visit http://www.osha.gov.
I do not wish to denigrate the good intentions of the many individuals and organizations whose efforts have contributed to CNT. Setting standards for a profession is a weighty and time-consuming responsibility. Nor do I wish to overlook the ways safety standards serve the profession, beyond preventing bodily harm. Safety standards contribute to cultural legitimacy, which in turn supports significant benefits and opportunities. But if safety standards are not at least in accord with federal OSHA regulations, then the profession’s legitimacy (and regulatory compliance) will be called into question. We need to recognize our shortcomings without recrimination, and then decisively step up to a higher level of performance in the development, adoption, expression, and improvement of professional safety standards.
This article was first published in the California Journal of Oriental Medicine, Vol. 18, No. 1. It is reprinted with permission from the CaliforniaState Oriental Medical Association (CSOMA). For information visit: www.csomaonline.org
Dr. Kailin is widely regarded as one of the foremost authorities on U.S. federal regulations impacting CAM. He is a former president of the Acupuncture Association of Washington (now known as WAOMA), and is the author of Quality In Complementary & Alternative Medicine. He resides in Corvallis, OR. To contact the author, visit his web site: http://www.convergentmedical.com
NAF, 2005. Clean Needle Technique Manual for Acupuncturists: Guidelines and standards for the clean and safe clinical practice of acupuncture. 5th Edition, English. USA: National Acupuncture Foundation.
OSHA, 2003. “Acceptable use of antiseptic hand-cleansers for blood borne pathogen decontamination and as an appropriate hand washing practice.” Occupational Safety and Health Administration, Standard Interpretations. 31 March 2003.
CDC, 2002. “Sterilization or Disinfection of Patient Care Equipment: General Principles.” Centres for Disease Control and Prevention. web site:
Australian Government Department of Health and Aging, 2004. ”Infection Control Guidelines.” web site:http://www.health.gov.au/internet/wcms/Publishing.nsf/Content/icg-guidelines-index.htm
Kailin D. 2006. Quality In Complementary & Alternative Medicine. Corvallis, OR: CMS Press. http://www/qualityincam.com