Access Denied

Edition: August 2006 - Vol 14 Number 08
Article#: 2469
Author: Repertoire

Calling on hospitals isn’t getting any easier, particularly for sales reps who call on clinical departments and decision-makers. Hospital executives cite patient, employee and visitor safety as the big drivers of the vendor access issue. No doubt other, longstanding issues are in play as well, particularly hospitals’ desire to control the influx of new technologies into their institutions.

For years, hospitals have printed and distributed “vendor access policies” to sales reps calling on their facilities. Traditionally, these policies simply stated that sales reps had to check in with the purchasing department prior to calling on other departments.

But recently, the checklist of must-dos for sales reps has been growing. Reps who spoke with Repertoire have produced “applications” from provider institutions asking for:

• Proof of a baccalaureate degree.

• Proof of current tuberculosis testing, hepatitis vaccination or immunity, and overall health status.

• Proof of having taken a course in aseptic technique.

• Proof of knowledge of patient confidentiality laws (specifically, those established by the Health Insurance Portability and Accountability Act of 1996, or HIPAA).

• Proof of professional liability insurance.

• Proof that the rep understands the technology he or she is selling.

• Signed certificate by a physician that the HCIR (stands for “health care industry representative”) does indeed know what he or she is doing.



Some hospitals and multihospital systems reportedly are conducting (or asking reps’ employers to conduct) criminal background and credit checks. At least one system is charging an application fee of $100 for reps who want to call on its facilities.

“Unfortunately, the little people are the ones to take this to heart,” says Harold Smith, clinical application specialist and regional manager for Products for Surgery, a specialty distributor based in Forest Hill, Texas. “This really affects us, because we don’t have big legal departments. The big [vendors] will probably suck it up and deal with it, as a cost of doing business. But I think it is going to get worse, certainly for the independents.”

Multitude of reasons

“We want to make sure that when people enter our facilities, we know where they’re going and that we can account for them,” says Pam Scagliarini, system director, supply chain management, Yale New Haven Health System, New Haven, Conn. Scagliarini is part of a provider/industry task force looking at the vendor access issue.

Furthermore, “from an operational and safety perspective, we need to make sure … that [when new technology] has to be utilized by a physician or staff member, they know what it is and how to use it,” she says. Reps play a key role in showing clinicians how to use new technologies.

Patient confidentiality is another big reason for the attention, she adds. “It’s of utmost importance that we protect our patients’ confidentiality. We can’t do that with open access, without some kind of voluntary controls.”

Reps in clinical areas affected most

Not surprisingly, the onus is falling on reps who call on clinical areas, including the OR and cath lab. Those who call on the OR should familiarize themselves with “AORN Guidance Statement: The Role of the Health Care Industry Representative in the Perioperative Setting,” published by the Association of periOperative Registered Nurses in its “2006 Standards, Recommended Practices, and Guidelines” (www.aorn.org/about/positions/pdf/HCIRep-2006.pdf).

The AORN document emphasizes the importance of proper training on new technology for perioperative team members, and the role that reps play in that process. “The healthcare industry representative, who has completed specialized training to provide technical instruction and support to the perioperative surgical team, expedites the procedure and facilitates desired safe patient outcomes,” says the guidance statement.

That said, the document outlines the “restricted role” reps should play in the perioperative setting, and the responsibility of the RN to monitor reps’ activities. “Each facility should develop a system that clearly delineates limits on the healthcare industry representative’s activities in the room where the surgical or other invasive procedure is performed based on community standards, accreditation requirements, and local, state, and federal regulations.”

Meanwhile, in September 2005, the American College of Surgeons (ACS) revised its “Statement on Health Care Industry Representatives in the Operating Room.” Similar to that of the AORN, the ACS statement urges surgical department administrators to establish written policies governing the presence of sales reps in the OR. The guidelines call for OR administrators to verify the documentation that certifies that sales reps have had training and education in HIPAA compliance and all matters related to patients’ rights and confidentiality, appropriate attire and conduct in the OR, aseptic techniques and sterile techniques, infectious disease and bloodborne pathogens, and occupational safety (including biohazardous waste, fire, electrical, radiation and other safety protocols). (See www.facs.org/fellows_info/statements/st-33.html for the guidelines.)

Manufacturers look at issue

AdvaMed, a Washington, DC-based association for medical products manufacturers, is tackling what General Counsel Christopher White refers to as “wide variation in the credentialing requirements” for sales reps. “[B]ecause each hospital seeks its own training and credentialing and generally does not allow reciprocity, representatives visiting multiple hospitals are forced to undergo wasteful duplicative training and credentialing at each hospital. Uniform, non-duplicative credentialing requirements and practices would be efficient for both the hospital and the representatives that are training staff how to use these cutting-edge technologies.” The association says it is working with industry leaders to come up with uniform policies “to enable industry representatives access … to ensure safe and appropriate use of cutting-edge medical technology.”

One organization — the Strategic Marketplace Initiative (www.smisupplychain.com) — has brought vendors and buyers to the table to arrive at voluntary vendor-access protocols that can be customized by providers to meet their specific purposes. Yale-New Haven’s Scagliarini participates in SMI’s efforts. Scituate, Mass.-based SMI (www.smisupplychain.com) is a non-profit organization comprised of hospital system executives and vendors. The organization believes that responsible, voluntary vendor-access guidelines that allow customization by providers and suppliers can lead to timely resolution of problems of issues related to access, improve patient and vendor safety, and reduce risk and liability between trading partners. SMI hopes to publish an industry guideline shortly.

Contrary to the belief of some in the industry, the Joint Commission on Accreditation of Healthcare Organizations does not have guidelines covering sales reps visiting healthcare institutions, according to a spokeswoman. That said, the organization is considering addressing the matter soon.