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People, Places, Processes & Products that Influence the Supply Chain

 
 

INSIDE THE CURRENT ISSUE

July 2007

CS Questions ● CS Answers

Making sense of the alphabet soup
of SPD regulations

by Ray Taurasi

Q JCAHO, AAMI, FDA, AORN, EPA, CDC, IAHCSMM, SGNA, DPH, ASHCSP... as a relatively new SPD coordinator all this alphabet soup has my head spinning. I feel like I am drowning in a sea of regulations. Then there are all sorts of requirements specified by manufacturers. Quite frankly I am having a rough time unraveling all this information and at times I feel like some of the information is contradictory. It’s very stressful thinking that if I miss one of these regulations my hospital could be shut down. How can one be expected to implement all of these standards and regulations into policies and procedures that can be strictly enforced? It seems to me that it would be a whole lot easier if there was just one source of information or body that regulates SPD operations.

A Being a newbie to the wonderful world of SPD I understand how overwhel-ming all this might seem to you. Let’s see if we can zoom in on all this alphabet soup and unravel some of the confusion for you. There are regulations, standards and guidelines which are considered and utilized in establishing protocols, procedures and policies relative to the practice of reprocessing and sterilization technology. Entities such as, FDA (Food and Drug Administration), EPA (Environmental Protection Agency), and OSHA (Occupational Safety and Health Administration) are all Federal Government agencies in such they are regulatory bodies. Each one of these agencies does have very specific regulations that impact SPD work practices, under the law their regulations must be implemented and enforce. Each one of these Federal agencies also has regional, state and or municipal divisions. All subdivisions or municipal bodies of these Federal agencies at minimum must abide by the Federal regulations. State or municipal divisions of these Federal Agencies may implement and mandate additional and or stricter regulations. In addition to federal agencies, states, counties, towns and cities might have other established regulatory agencies, such as, DPH (Department of Public Health). Therefore in the development of department policies the SPD manager must be familiar with the Federal, as well as, the local, state and municipal governing bodies’ regulations. Regulations are established and enforced by governmental empowered agencies. Institutions are bound by the legal system to implement and enforce regulations; violators are subject to severe penalties and fines. Penalties could include loss of license to operate.

JCAHO (Joint Commission for Accreditation of Healthcare Organizations), AAMI (Association for the Advancement of Medical Instrumentation), AORN (Association Operating Room Nurses), CDC (Center for Disease Control and Prevention), IAHCSMM (International Association of Healthcare Central Service Materiel Management), SGNA (Society of Gastroenterology Nurses and Associates, ASHCSP (American Society of Central Service Professionals) as well as many more not mentioned are all organizations that are very important to the practice of Sterile Processing. Each of these entities do publish recommendations, guidelines and recommended standards of practice. These entities are not empowered by the government and their published guidelines are not regulations. Participation in these organizations and the compliance to their recommendations and or standards are generally considered voluntary. However there are local governments that have incorporated some of these standards into their regulations. Such is the case in the state of New Jersey where the state Department of Health (DPH) requires that hospitals follow AAMI recommendations, standards and guidelines.

JCAHO is a voluntary entity that conducts audits, assessments and accreditation for healthcare organizations. While JCAHO accreditation is voluntary its importance is critical to most healthcare organizations. Without accreditation a hospital may not be able to receive certain benefits, funding and reimbursement for programs and services they render.

The fact that these entities are voluntary and non governmental does not dismiss their importance and or value to sterile processing practitioners. The documents, guidelines and recommendations they publish have often been developed based on sound scientific, technical and clinical data. Contributors to the development of their documents and the pre publication reviewers are comprised of highly qualified and seasoned professionals from the many specialized fields of practice in the clinical and manufacturing disciplines. Most of the published standards and guidelines provide supported rationale and sound reasoning for each recommendation. It is very important that sterile processing managers are familiar with and keep abreast of the standards and guidelines published by professional entities. The knowledge gleaned from these documents provides an excellent resource and reference base for you to utilize in the development of your policies and procedures. It is impossible for the professional entities to address every possible scenario, medical device, piece of equipment, or technology–the dynamics in today’s healthcare environment precludes this. Each hospital has its own uniqueness. Technological advances are occurring all the time and new products are being introduced into the marketplace that may affect the way we practice. Therefore certain recommendations or guidelines might not be a fit or apply to your unique situation or facility’s operations. In such you may choose not to implement or follow certain recommendations or guidelines published by voluntary entities. As professionals we are expected to be competent, educated, knowledgeable, and well informed. We are responsible for what we do and must ensure that we maintain excellence in the quality of patient care including minimizing the risk of infection or injury to the patient. When developing SPD polices and procedures you must consider the recommendations of professional entities, and manufacturers. Much of what we do in SPD aside from the aforementioned government regulations require sound judgment in practice. All matters are not black and white. There are gray areas and choices which require a judgment call and for a decision to be made by you the SPD manager. You must be able to indisputably defend your decisions. This is especially so when your decision or practice may differ from guidelines and recommendations set forth by professional entities. Although not binding by law such guidelines and recommendations can become standards of practice and could possibly be entered as evidence in legal cases involving malpractice and or negligence.

Ray Taurasi is eastern regional director of clinical sales and services for Healthmark Industries.