Salespeople in operating room pose risks, require vetting and guidelines

Salespeople in operating room pose risks, require vetting and guidelines

Vendor credentialing by outside companies gaining more attention

By Joy Daughtery Dickinson, Executive Editor

(Editor’s note: This is the first part of a two-part series on sales reps in the OR. This month we give you an overview of how outpatient surgery providers are addressing the issue. Next month, we discuss how to use an outside company to credential sales reps and how to inform patients that reps will be in the OR.)

As much as managers might like to tightly control access to patient care areas and other sensitive parts of a healthcare facility, the nature of the business requires having salespeople and other vendors on-site regularly. Perhaps the most invasive visitor is the salesperson who needs to be in the OR during surgery to provide guidance to a doctor using new equipment.

Healthcare facilities are tightening their policies and procedures on those visitors, with many implementing requirements for training in infection control and OR protocol, along with immunizations and background checks. Dan Flynn, a surgical instrument sales representative with K&D Medical in Columbus, OH, has been visiting ORs during procedures for 35 years and says facility policies have changed a great deal in that time.

"They had to put a stop to the free flow of reps going into the OR. It was just too much," Flynn says. "Thirty-five years ago, there were just a handful of us going into the OR, and we were trained, and the hospitals knew they could trust us. Now there are so many reps that hospitals are saying they need some way to certify us and verify that we can be there without threatening patient safety."

Facilities always have expected surgical salespeople to be knowledgeable about OR procedures and never interfere with the procedure, Flynn notes. They are not allowed to make a sales pitch of any kind during the procedure, he says. Rather, they are there to observe, for their own benefit, and to offer guidance to the surgeon on how best to use the instrumentation. Most equipment manufacturers provide training for their salespeople on how to conduct themselves properly in an OR or other patient care setting.

However, now facilities are requiring more formal training in bloodborne pathogens, privacy issues, and similar concerns, Flynn says.

Avoid liability with training

The increased focus on vendor credentialing is necessary to protect patients and avoid significant liability risks, says Sharona Hoffman, JD, professor of law and bioethics, Edgar A. Hahn professor of jurisprudence, and co-director of the Law-Medicine Center at Case Western Reserve University School of Law in Cleveland, OH.

It is prudent to require training of salespeople before allowing them in the OR, she says. At a minimum, the person must be briefed on protocol and the major do’s and don’ts during surgery, she says. It would be better to have a formal training program on all the issues of concern, she says. Also, Hoffman says managers should require that the salesperson have a good reason for being in the OR.

"It’s reasonable to say that the surgeon is using a new instrument or device and might need some advice from the salesperson during the procedure. That is a legitimate reason to be there," Hoffman says. "If the salesperson wants to be there just to see the device in use, to gather information for the manufacturer, that’s probably acceptable too. If the person wants to be there just out of curiosity, probably not."

Barbara Smith, administrator at Beckley (WVA) Surgery Center, reports that at other centers where she has worked, sales reps repeatedly showed up to meet with surgeons in the OR, although their meeting had nothing to do with a particular case. "That has happened for so long, it’s not even funny," Smith says.

Smith become so frustrated with their actions that she took a policy to her board enforcing the right of her staff to say to a rep, "We’re sorry. We can’t let you in scrubs and let you go in the back. You have no reason to be back there with the doctor at this point. He’s doing an eye case, and you want to talk to him about something else."

When reps regularly abused the privilege, Smith talked to the doctor in advance to tell them about the policy and that it would be enforced. Additionally, reps aren’t allowed in the ORs if the patient hasn’t signed off to allow it, she adds.

Patient privacy is a significant concern regarding sales representatives in the OR. The vendor does not have a formal relationship with the patient and therefore is not legally required to comply with Health Insurance Portability & Accountability Act (HIPAA), Hoffmann says. However, the facility should require compliance as part of its approval process, she says.

"The visitor in the OR should be required to follow all privacy rules, and that means they have to understand HIPAA and how it can be violated," Hoffman says. "There are obvious restrictions like no video cameras or photographs, but the salesperson also should be required to follow all HIPAA requirements just as if he or she was an employee of the hospital."

How do surgery programs handle?

Here is a round-up of how some outpatient surgery providers are handling reps in the OR:

• TMC Orthopaedic and Surgical Tower, Tucson, AZ.

"We do allow sales reps to be in the operating room with the surgeons for the sole purpose of assisting the scrub tech with a new product when and where necessary," says Stuart Katz, MBA, FACHE, director of the orthopaedic service line. However, the center has a strict policy against "up-selling" anything during a procedure.

Sales reps must have had all immunizations that are required of staff and surgeons, Katz says. "If we don’t have their information on file or they don’t bring it with them, they’re SOL."

* West Morris Surgery Center, Succasunna, NJ, and Rockland Bergen Surgery Center in Montvale, NJ.

Use a vendor credentialing service so the center will know the rep is compliance with infection control issues such as TB skin tests, advises Bonnie Brady, RN, CNOR, administrator.

Also, patient approval is an important piece of the process, Brady says. "You should get a patient signature or include it in your consent and know that the patient is OK with it," she says.

At her centers, vendors must sign in and be aware of fire policies and procedures, Brady says. Additionally, reps should be identified as a guest with a badge or with a different colored OR cap, she says.

• Grant Bone and Joint Center, Grant Medical Center, Columbus, OH.

Hospitals in central Ohio are requiring companies to wear red bouffant OR caps, says Gail Ramm, RN, BSN, clinical nurse educator.

"The reps can be easily picked out of a group of people, and the staff can easily identify them if they should need assistance with education of instrument sets, implants, etc.," Ramm says.