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Kaiser Fined for Phlebotomy Practices, Policies; Safety Needles Called Ineffective

A Kaiser Permanente Hospital in Los Angeles was fined nearly $30,000 recently after an inspection revealed violations of state OSHA standards, including the Bloodborne Pathogens Standard. The citations, issued to the Kaiser facility at 4747 Sunset Boulevard, included minor penalties for failure to maintain a detailed sharps injury log and for lacking an effective exposure control plan. The most stunning citations---failure to use devices with engineered sharp injury protection and for removing needles from tube holders---brought fines of nearly $10,000 each.  Although the facility uses the BD Eclipse brand sharp injury protection device, the citation states that it "does not meet the definition of a needle with engineered sharp injury protection."
According to the citation, the facility was fined $425 for having missing or incomplete information in its sharps injury log regarding details of exposures, lacking was information regarding the time of the incident, type and brand of sharp involved, the procedure being employed at the time of the exposure, how the incident occurred, if the incident occurred before or after activation, and the employee's opinion as to how the incident could have been prevented. The violation was classified as a General Citation.
Also a General Citation, CalOSHA found that lapses in the facility's exposure control plan rendered it ineffective. Specifically, the facility was cited for not incorporating effective procedures for gathering information required by the sharps injury log, not having procedures in place for reviewing and evaluating exposure incidents or determining the frequency of use of sharps involved in exposures, not having a procedure for identifying and selecting currently available engineering controls, the lack of a procedure for documenting patient safety determinations and for not having a procedure for involving employees in the review and update of the exposure control plan. For these violations Kaiser was fined $850.
Other General Citations include impeded access to an electrical panel and an eyewash station, bringing fines of $210 each and unrestrained gas cylinders in the bacteriology department for which a $1060 fine was levied.
 A citation classified as "Serious" was issued when an unused carbon dioxide cylinder was found without a valve protection cap in the bacteriology area of the laboratory. For the violation, Cal-OSHA levied a $7650 fine.



Also a General Citation, CalOSHA found that lapses in the facility's exposure control plan rendered it ineffective. Specifically, the facility was cited for not incorporating effective procedures for gathering information required by the sharps injury log, not having procedures in place for reviewing and evaluating exposure incidents or determining the frequency of use of sharps involved in exposures, not having a procedure for identifying and selecting currently available engineering controls, the lack of a procedure for documenting patient safety determinations and for not having a procedure for involving employees in the review and update of the exposure control plan. For these violations Kaiser was fined $850.
Other General Citations include impeded access to an electrical panel and an eyewash station, bringing fines of $210 each and unrestrained gas cylinders in the bacteriology department for which a $1060 fine was levied.

A citation classified as "Serious" was issued when an unused carbon dioxide cylinder was found without a valve protection cap in the bacteriology area of the laboratory. For the violation, Cal-OSHA levied a $7650 fine.

Two other Serious Citations, however, have generated a significant buzz in some sectors of  the health devices industry and shockwaves in others. Inspectors penalized Kaiser $9560 when they deduced that the sharps injury protection device in use, the BD Eclipse, "does not effectively reduce the risk of an exposure incident, and it causes splashing, spraying, spattering and/or generation of droplets of blood." 



The Service Employee's International Union (SEIU), the nation's largest healthcare union, has long held that the device is substandard according to an article in the June 15, 2001 issue of Cal-OSHA Reporter (COR).  SEIU told a COR reporter that many users activate it by pushing it against the edge of a table, a method not intended by the manufacturer. According to product literature, the Eclipse is to be activated by the thumb. Bill Borwegen, occupational safety and health director for SEIU, told COR that a number of workers have received needlesticks while activating the device and one worker was treated for an exposure "when blood splashed into his or her eye."

     A warning statement exists on Eclipse boxes stating "activation may result in splatter of blood from the needle.  For greatest safety, use thumb technique and activate away from self and others."
 

But it may not be the device that is faulty, according to California's Division of Occupational Safety and Health (DOSH) special counsel Len Welsh, but the way Kaiser employees activate it.  The COR reports Welsh as saying "We're not making an announcement per se that the Eclipse device is unacceptable but that the way it was used may be a problem."  He stressed that by issuing the citation, Cal-OSHA isn't saying the product should not be used. Welsh also announced that DOSH is preparing to explore the circumstances surrounding the citation to see if further recommendations are necessary. The statements came after SEIU began circulating a document proclaiming that the use of Eclipse "appears to be a violation of the Cal-OSHA standard." According to the COR report, inspectors were drawn to the Kaiser facility by complaints originating from SEIU.

BD has been criticized in the past, most recently on CBS's 60-Minutes, for retrofitting conventional needles instead of redesigning them with built-in safety features. But in a statement from BD in response to the 60-Minutes piece, the company maintains that the Eclipse is one of the safest products on the market. BD expressed that "concern about healthcare worker safety is paramount to every employee at BD.... We have sold tens of millions of [Eclipse] units and received only four complaints. None resulted in the transmission of disease."

A second Serious Citation was issued when inspectors found that phlebotomists at the facility were reusing tube holders.  According to state and federal OSHA Bloodborne Pathogens Standard, "needles and other contaminated sharps shall not be bent, recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure." The facility was fined $9650 for the infraction.  It is the second such violation in the state. Last year, DOSH  fined Seton Medical Center in Daly City $1,125 for failing to keep employees from removing contaminated phlebotomy needles from tube holders.

Inspectors also found half- and one-inch insulin syringes without engineered sharps injury protection (ESIP) in the Medical/Surgical unit, fistula needles with sharps without ESIP in a hemodialysis unit and syringes without ESIP in the outpatient laboratory. 

According to Kaiser Permanente spokesperson Jim Anderson, Kaiser disagrees with Cal-OSHA's inspectors. "Kaiser Permanente is appealing the citations and expects to have many of them dismissed," says Anderson. "We have always been in the forefront in providing safety needles to our employees. We did so long before legislation was enacted and will continue to do that."
 
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