• E-mail
• Print
• RSS

Special report: Hospitals and rep credentialing programs

Device Regulation Alert: Safety, Compliance and Reimbursement News, May 28, 2007

Across the country, vendor access, or "credentialing," programs are restricting medical device and other healthcare industry representatives from entering hospitals without certain training or precautions. Hospitals may require that representatives who enter their facilities are aware of their compliance programs or are vaccinated against certain diseases, especially if the rep is going to be in the operating room.

"There are a number of potential legal landmines out there. So it makes sense to make sure device reps in the operating room are cognizant of those rules," according to Charles B. Oppenheim, Esq., a partner at Foley & Lardner LLP. He cites issues such as patient privacy, confidentiality, blood borne pathogens, and OSHA sterile procedures.

"The hospital has an interest in knowing who is in there and knowing that that person has signed on to the hospital's policy and compliance processes," Oppenheim says.

David L. Feldman, MD, vice president for Perioperative Services at Maimonides Medical Center in Brooklyn, NY, agrees. Feldman points to his own hospital's program, which requires that vendors provide a statement of expertise, a resume, and evidence of tuberculosis testing for reps in the OR. He says Maimonides also requires a Certificate of Competency, which includes information such as the number of procedures in which the reps have participated and their areas of expertise and training.

Although the effort is toward improving patient and physician safety, these programs are often repetitive for reps. According to Christopher L. White, Esq., executive vice president, general counsel, and secretary at AdvaMed, there is a lot of unnecessary duplication in terms of training and background verification between what hospitals now require and what device companies already perform. He says there is a general lack of reciprocity among hospitals, meaning that reps must undergo hospital-specific credentialing for each facility where their presence is required.

In addition, White says AdvaMed members have seen a proliferation of hospitals that have their own credentialing standards. In many cases, the vendor credentialing systems and standards are copied from existing hospital standards and procedures that apply to medical staff.

This one-size-fits-all approach to credentialing often doesn't consider the functions that the individual reps perform. White says hospital training is often premised by the assumption that reps enter the OR, but this is not always the case. Hospitals are often surprised to learn the various roles that reps play in hospitals, such as consulting, clinical trials, or engineering, which may or may not put them in contact with patients.

White says that device companies historically have implemented tailored training and background verification programs for their own employees, and according to Oppenheim, that's a good idea.

He says device companies should perform training, and document the training, experience, and credentials of their employees.

"Even aside from hospitals stepping up their level of scrutiny, you don't want to be caught flat-footed if there's a bad outcome in a procedure," Oppenheim says.

There are also efforts underway to try to standardize the credentialing requirements for reps. White says AdvaMed has a multidisciplinary, vendor-access working group to develop best practices to promote greater uniformity among hospital requirements that are tailored to the functions performed by device company reps. The American College of Surgeons developed a Statement on Health Care Industry Representatives in the Operating Room. Earlier this month, the Joint Commission announced an upcoming field review to cover a proposed new standard addressing healthcare industry reps that provide training and guidance regarding medications, medical equipment, devices, supplies, and procedures in the presence of patients.

How is your company dealing with the issue of rep credentialing? Click here to take our fast, confidential survey and receive our free white paper on hospital requirements for credentialing healthcare industry representatives.

• E-mail to a Colleague
• Print
• RSS
• Archive