Needlestick Law May Prevent Injuries, Raise Costs
The Needlestick Safety and Prevention Act signed into law last month by President Clinton may prevent injuries to the nation's 8 million healthcare workers, but it is sure to raise costs to hospitals, ASCs and other health care facilities.

The Act requires that healthcare facilities implement the use of "safer medical devices" to minimize accidental punctures or cuts from needles and other "sharps." The Act asserts that healthcare workers suffer 600,000 to 800,000 accidental needlestick injuries each year, and the needles may be contaminated with HIV, Hepatitis C or other bloodborne pathogens.

The new law puts some teeth into what has been an Occupational Health and Safety Administration (OSHA) directive since November 1999. OSHA has the responsibility of enforcing the Act during inspections of healthcare facilities.

"We've been using the safety devices since the OSHA directive, and I would guess that many other ASCs have been too," says Monica Young, Patient Care Manager at the Ambulatory Procedure Center at Lankenau Hospital, Philadelphia, Pa. "But we aren't fully implemented, and it will take some time before that happens."

The new law takes effect in nine months. But healthcare professionals are worried, citing a shortage of the new, safer medical devices, the need to re-train workers to use them, and a lack of consistency from OSHA.

"The healthcare industry doesn't have the depth and breadth of the product line that you really need," says Linda Akiens, director of procurement for a 437-bed hospital in Houston, Texas.

Instrument manufacturer Becton Dickinson, of Franklin Lakes, NJ, says it is prepared to produce blood collection devices and intravenous catheters, the two areas where risk is greatest. But BD says it may not have enough supply to meet the demand for re-engineered syringes. Right now, BD is only halfway through a three-year, $300 million conversion to meet demand.

Kevin Siefert, BD vice president of advanced protection technologies, says only 25 percent to 30 percent of all syringes used by healthcare facilities come in contact with bodily fluids. If, for now, they only use safety devices when bodily fluids are contacted, the industry can meet the demand, Siefert says.

Yet the Act requires facilities to implement the use of new devices in place of all needles and other sharps. OSHA has said it will take the industry shortage into consideration during inspections, but experts are concerned.

"It is very difficult to get all the OSHA people singing off the same song sheet," says Gina Pugilese of Premier's Safety Institute, Chicago. "It will be important for facilities to document what they are doing and how they are doing it."

The new devices cost more, in some cases about $1 per unit. There's also added cost because some devices come in two parts.

Ms. Young says her facility has been using the Protective Plus syringe tip, which requires the use of an adapter on every medication bottle. It's more work for her staff, and additional supplies are needed.

"The staff is taking two extra steps each time, so it's a lot more work. Sometimes they don't comply. We're using additional products, so even if they only cost a penny, they will increase our costs," she says.

Ms. Young notes that the precautions required by the Act make sense with IV injections, but still won't prevent all needlestick injuries: "You'll still have to give IM injections, and you can still stick yourself."

HCFA Removes 44 Procedures from "Inpatient Only" List
On Jan. 1, hospital outpatient surgical centers will get a modest gift from HCFA, although freestanding ASCs will be left out in the cold.

Last month, HCFA published a regulation that deletes 44 procedures from its "inpatient only" list, permitting these procedures to be performed on Medicare patients in both outpatient and inpatient settings. But the rule change only applies to outpatient centers associated with a hospital, and not freestanding ASCs.

"Many of our members are confused about this change," says Kathy Bryant, executive director of the Federated Ambulatory Surgery Association (FASA). "They don't realize it only applies to HOPD's (hospital outpatient surgery departments) and not to ASCs. It really only applies to a few of our members."

At the same time, Ms. Bryant concedes that HCFA is moving in the right direction regarding outpatient surgery. The rule change is a response to comments received from surgical groups such as the American College of Surgeons.

The new HCFA rule asserts: "We have attempted to limit the inpatient only list to those procedures that, in current medical practice as understood by our clinical staff, require inpatient care, such as those that are highly invasive, result in major blood loss or temporary deficits of organ systems (such as neurological impairment or respiratory insufficiency), or otherwise require intensive or extensive postoperative care."

HCFA removed from the inpatient list certain breast and other cancer procedures, repairs of facial trauma, many orthopedic procedures, several vascular procedures, some genito-urinary procedures, excision of chest wall tumors, several orthopedic repairs, vascular procedures, and ureteral endoscopies.

HCFA refused to remove some procedures from the inpatient list, such as "various spinal procedures, including osteotomies and laminectomies. We also are not removing several open abdominal and retroperitoneal procedures from the inpatient list because many of these procedures involve prolonged invasion of the thoracic cavity, the peritoneum, or the retroperitoneal space. Patients undergoing these procedures typically require prolonged postoperative monitoring."

However, HCFA says it will reconsider these decisions as technology and patient care evolve: "We are aware that, with advances in technology and surgical techniques, many of these procedures may eventually be performed safely in a hospital outpatient setting. We will continue to review all the procedures on the inpatient list and will consider additional requests to move specific procedures to the outpatient setting."

HCFA promised to review the inpatient list on a quarterly basis, beginning April 1, 2001, to see if additional procedures could be removed.

But Ms. Bryant is not impressed: "Forty-four procedures isn't that many, when you consider there are 6,000 procedures already on the HOPD list. The ASC list only has 2,000, although ASCs and HOPDs are mirror images of each other. You would expect that if it is approved for one, it's approved for the other, but that's not the case."