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Special report: Hospitals and rep credentialing programs

Pharma Compliance Alert, May 30, 2007

Across the country, vendor access, or "credentialing," programs are restricting 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," 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.

According to Christopher L. White, Esq., executive vice president, general counsel, and secretary at AdvaMed, his group's 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.

The experts agree that 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. 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.

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