Full article reprinted from "The Gray Sheet" - March 30, 2009
Find out how AdvaMed hopes a proposal it released last week with 10 other health care groups will advance a dialogue to promote national harmonization for credentialing company sales representatives to work within clinical settings.
The coalition, which includes the Medical Device Manufacturers Association, the American Association of Critical-Care Nurses and the Health Industry Distributors Association, put out a five-point list of recommendations March 24. It emphasizes the need for hospitals to accept written assurances from a sales rep's employer on matters including vaccinations, liability insurance and criminal background checks.
Device firms are responding to what they say are an increasing and diversified set of costly and time-consuming documentation requests from hospitals as prerequisites for their employees to begin working at a facility (1"The Gray Sheet" March 24, 2008, p. 14).
Hospitals, meanwhile, worry about patient safety and liability if a rep turns out to be unqualified.
AdvaMed has been involved in ongoing discussions on this issue with the non-profit Joint Commission, the primary standards-setting body for hospitals in the U.S. While the commission supports the general concept of a national standard for vendor credentialing, it would like to see a neutral organization, rather than individual companies, assess the competency of representatives.
Standards Could Avoid Delays, Higher Costs
Vendor credentialing is "an evolving area with no clear pathway" due to overlapping state privacy and employment laws, as well as federal and state health care regulations, explained Terry Chang, director of legal and medical affairs for AdvaMed.
Without a move towards standards, Chang said, managing the multiple requirements from various hospitals could cause delays to providing technology or technical support, as well as add to the cost of care "without offering anything in exchange."
The AdvaMed-led coalition recommends that industry reps working in the immediate vicinity of patient care should be required to provide an employer statement showing that an annual tuberculosis test has been performed, as well as updates on mumps, measles, rubella (MMR) immunity and hepatitis B vaccines. The group argues that the records should be maintained by device reps or employers, and not by the hospital.
The best practices proposal also argues against hospitals seeking personal liability coverage for device reps, but advises companies to provide hospitals with a copy of the company policy or a certificate of liability insurance as it applies to reps in health care settings.
Employee Privacy Is At Issue
Under the recommendations, hospitals should expect letters from device companies stating that a background check was performed for all reps upon hire. Typical employment verification might include a criminal background check, health care sanction review, sex offender registry check or drug screen, although privacy laws vary by state.
Out of privacy concerns, employment records should be kept in the reps' human resources offices, not by the hospital, the coalition proposes.
Some of the documents that are requested do not "reasonably relate" to sales reps' actual jobs, Chang said, adding that device companies want to safeguard private employee information.
He cites frequent experiences "where people had no assurances as to how information would be maintained," even when such information included social security numbers or credit checks.
A fourth recommendation is for hospitals to conduct unit orientation for vendor reps within specific procedural areas, such as operating room protocol, procedure suite protocol and intensive care unit protocol. Device reps should learn and observe any hospital rules and policies regarding appointments, check-in or knowledge of emergency procedures, the coalition says.
Some physicians have said that device reps play a crucial role in providing technical support, but should be careful not to use heavy sales tactics in the surgical suite (2"The Gray Sheet" Dec. 8, 2008, p. 11).
The final proposed recommendation would require a letter from the company stating that a rep has completed device- and procedure-specific training, as well as training on patient confidentiality and privacy, industry-specific codes of ethics, blood borne pathogens and, when appropriate, sterile/aseptic control and radiation safety.
Joint Commission Sees Need For "Neutral Body"
The recommendations issued by the coalition "all seem fine as the first tier to see whether somebody should be allowed to do their work inside of the organization," said Robert Wise, M.D., VP for the Division of Standards and Survey Methods at the Joint Commission, in an interview.
However, he added that "until there is a clear neutral body that can judge competency of representatives, it would be premature for the Joint Commission to make standards requiring hospitals to make an independent determination of competency."
The Joint Commission is focused on ensuring the competency of professionals who interact with patients in the hospital setting, Wise said.
Physicians are judged by their board certifications, and nurses have their own licensure requirements, he explained.
"The problem here is that the [device] industry has not evolved to the point where there are national standards that determine what a competent person is" who works as a rep involved with, for example, a knee or pacemaker implant, Wise said.
Vendor credentialing as proposed in the AdvaMed recommendations sets up a potential conflict of interest because device companies are the ones vouching for their own employees.
"They've obviously hired the person, they have put all the money into the person," Wise pointed out. "It's not that I'm saying they are not telling the truth," he stressed. "It's just that they have a vested interest in saying that that person is competent."
"Obviously, they wouldn't send somebody to the hospital who they didn't think was competent, but from a hospital's point of view, they would prefer to be able to have some kind of more neutral body, one with less of a conflict of interest than the company who is actually hiring the rep and sending them in."
AdvaMed's Chang acknowledges that the concept of centralized licensure or certification for sales reps appeals to some. A major complicating factor, he points out, would be the challenge of developing standardized exams due to differences among technology across manufacturers, even within a similar disease state and class of device. He also notes that there is no established state or national body with experience credentialing industry representatives.
Wise suggested, though, that it could be the industry itself that creates the outside credentialing body, if companies can come together to make shared judgments on "who is competent and who is not."
"These are very specific types of jobs, and it's the industry who understands best what competency is," Wise noted.
AdvaMed Hopes For Consensus
Chang said that the association's original working group on credentialing had more than 70 participants, including lawyers and compliance experts, as well as human resource and contract management specialists.
In creating its proposed standards, AdvaMed "sought to engage as many stakeholders in this space as possible," Chang said. He specifically pointed to the Association of peri-Operative Registered Nurses (AORN) as "integral in ensuring that the clinician sides of the equation were properly integrated into what could be offered as a model that would help to promote more uniformity."
Other groups signing on to the proposal are: the Association for Healthcare Resource & Materials Management; the Health Industry Representatives Association; the Healthcare Manufacturers Management Council; the Independent Medical Manufacturer Distributors Association; the Industry Partners for Patient Safety; and the Innovative Healthcare Access Coalition.
"Where there are concerns that haven't been addressed, the groups involved welcome that type of feedback," Chang said. "It would be ideal to incorporate that feedback into the proposal as well."
- Monica Hogan
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