Healthcare Managers Re-tooling for Compliance
By Dennis J. Ernst MT(ASCP)
Dennis J. Ernst has written this article at the invitation of ISIPS, the International Sharps Injury Prevention Society for the first-ever International Sharps Injury Prevention Awareness Month scheduled fro December 2002. [Printed in Managing Infection Control, Octover 2002, Volume 2, Issue 10, pp. 52-53]
Most healthcare workers are aware that OSHA issued the Bloodborne Pathogens Standard (BPS) in 1991 to protect them from acquiring any of the 20 different diseases that have been shown to be transmitted by blood exposure. When it comes to removing needles so that tube holders could be reused though, everyone seemed to have a different interpretation. Earlier this year, OSHA put an abrupt end to over ten years of speculation by issuing what’s affectionately known within the agency as “the infamous Kline letter” and its companion “Letter of Clarification.”
According to the
standard as originally written, “contaminated needles and other contaminated
sharps shall not be bent, recapped or removed unless the employer can
demonstrate that no alternative is feasible….” The term “feasible” was
interpreted by many to mean that justification for needle rem
oval
and subsequent tube holder reuse was possible and, therefore, ultimately
acceptable. Since it was up to the manager to include justification in the
facility’s exposure control plan, exactly what rationale, if any, would
satisfy inspectors was left to optimistic speculation. Pressure to draft
justification was further supplied by the enormous increase in expenditures
and volume of biohazardous waste that discarding tube holder after each use
promised to inflict on laboratory budgets.
Heightened concern for the hundreds of thousands of healthcare workers who sustained accidental needlesticks annually caused OSHA to issue a Compliance Directive on November 5, 1999 to help inspectors enforce the intent of the standard. However, some interpreted a passage in the directive detailing the form justification must take as an indication that needle removal might be acceptable under certain circumstances. “An acceptable means of demonstrating that no alternative to [removing] contaminated needles is feasible…would be written justification (supported by reliable evidence)….”
However, floods of requests from managers for a more definitive edict continued, so on July 12, 2002 OSHA issued a new Compliance Directive replacing the 1999 document. In it, a subtle but significant modification provided what some considered as indisputable evidence that it was OSHA’s intent that tube holders not be reused. Whereas the 1999 directive stated, “Needles must be used and immediately discarded,” the revised directive stated, “Devices with needles must be used and immediately discarded….”
Nevertheless, this subtle change in the language didn’t speak loudly or
clearly
enough for those still wrestling with the issue. Exerting further
pressure on OSHA to clarify the issue were numerous studies showing that a
high percentage of tube holders were contaminated by blood even after one
use. Therefore, on June 12, 2002, OSHA administrator John Henshaw issued a
public response to a letter sent to the agency by Dr. Douglas Kline, an
infection control practitioner in Westchester, Pennsylvania and posted it on
its web site as the agency’s “Letter of Interpretation” on needle removal as
it applies to tube holder reuse.
“We want to make it very clear that this practice is prohibited….” wrote Henshaw. With the infamous Kline letter, along with a companion “Letter of Clarification” (both posted on the agency’s web site at www.osha.gov), OSHA’s stance on tube holder reuse is clear, firm and impossible to misinterpret.
A driving force behind the ban is OSHA’s intent to protect downstream waste handlers who may come in contact with discarded contaminated needles. “Close to half of all injuries from contaminated sharps occur to those who are not in immediate control of the device, but to those who come in contact with the unprotected needle downstream (e.g., nursing assistants, housekeepers, maintenance personnel),” writes Richard Fairfax, the agency’s Director of Compliance Programs, in the Letter of Interpretation. “Removing contaminated needles and subsequently reusing blood tube holders poses multiple potential hazards.”
As a result of the Letter of Clarification and the Letter of Interpretation, managers are looking to manufacturers to help them comply at the lowest cost possible. “Not only are managers demanding low-cost tube holders, but they want devices that take up the smallest volume possible in sharps containers, keeping the increase in the cost of disposal to the absolute minimum,” says Pete Talarico, Blood Collection Product Manager for Tyco/Kendall.
“Savvy managers want products that provide compliance not only with the Letter of Clarification, but also with last year’s revised Bloodborne Pathogens Standard, which mandates implementation of needles with engineered sharps injury prevention features,” says Talarico. “They’re looking at products that combine sharps injury protection features with a disposable tube holder as providing a turnkey solution to both mandates.”
Hospitals and physician office laboratories are already being inspected for compliance with the needle removal ban. Acting on an employee complaint that tube holders were being reused, an OSHA inspector paid one large midwestern teaching hospital a surprise visit shortly after the clarifications were issued. Although the facility provided ample evidence that a single-use tube holder policy was in effect and no violations were found, it is clear that OSHA is vigorously applying the standard and is prepared to issue fines. Violations of the Bloodborne Pathogens Standard can carry up to a $7000 fine per instance.
Author bio:
Dennis J. Ernst MT(ASCP) the director of the Center for Phlebotomy Education, Inc. in Ramsey, Indiana and Administrative Director of Phlebotomy West. In addition to conducting phlebotomy workshops, conferences and presentations throughout North America and Europe, he serves as an expert witness in cases involving phlebotomy-related injuries. He is the author of Phlebotomy for Nurses and Nursing Personnel and editor of Phlebotomy Today, an online phlebotomy newsletter accessible at www.phlebotomy.com