KEYFOR HEALTH CARE ORGANIZATIONS

JULY 2010 IN THIS ISSUE: on Your OR Door? Vol. 3 No. 1 KEYFOR HEALTH CARE ORGANIZATIONS Author: Karen Everitt, BSN, JD Regional Vice President If you have questions on this topic, please contact Ms. Everitt at 800.292-6242, extension 4703, or email at keveritt@proassurance.com. In the 1970s and again in the late 1990s, visitors in the operating room (OR) was a hot topic for health care facilities who were aware of the few, but wildly expensive, malpractice claims involving vendors in ORs. Subsequently, health care organizations developed policies and procedures, using guidelines from the American College of Surgeons 1 and the Association of perioperative Registered Nurses, 2 and the headlines subsided. But in 2004, an Ohio jury awarded $1.75 million in a medical malpractice lawsuit against a neurosurgeon and a sales representative after the representative made treatment recommendations which the neurosurgeon followed. 3 Today, rapid advances in medical technology have made sales representatives fixtures in ORs. The number of OR visitors has led facilities to search for appropriate professional liability coverage (one hospital system found that 6,000 vendors visited two of their hospitals every year). 4 Professional and general liability coverage for sales representatives and vendors was created to address gaps in facilities coverage. In recent years, Medical Sales Advocates a professional society for medical sales representatives has offered its members both professional and general liability insurance. The advent of this type of insurance indicates the tremendous number of visitors in ORs. As such, it s time to reassess your visitor policies and procedures, your credentialing of sales representatives, patient privacy issues, and your informed consent process. 1 American College of Surgeons. (ST-33) Statement on Health Care Industry Representatives in the Operating Room. Statements of the College (2005), http://www.facs.org/fellows_info/statements/st-33. html (accessed June 10, 2010). 2 Association of perioperative Registered Nurses. Role of the Health Care Industry Representative in the Perioperative/Invasive Procedure Setting. AORN Position Statement (2009), http://www.aorn.org/ PracticeResources/AORNPositionStatements/Position_HealthCareRepresentative (accessed June 10, 2010). 3 Zappola v. Leibinger, 2006 WL 1174448 (Ohio App. 8 Dist.). 4 Gutman, Mary. Collaborating to Manage Vendor Interactions and Protect Quality of Care in the OR. Journal of Healthcare Risk Management 25, no. 3 (2005). Continued on page 2

(Continued from page 1) Decide whether sales representatives or other visitors will be allowed in ORs, procedure rooms, and other patient care areas. Facilities allowing visitors should define the visitors role and limitations. Vendor or Visitor Policies & Procedures Health care facilities should first decide whether sales representatives or other visitors will be allowed in ORs, procedure rooms, and other patient care areas. Facilities allowing visitors should define the visitors role and limitations. Policies and procedures should comply with state and federal laws and be consistent with the facility s existing policies. A difficult question facing facilities is whether sales representatives will be allowed to participate in patient care. While Arkansas, Illinois, and Washington, D.C. regulate OR visitors, facilities elsewhere must look to other sources for guidance. The American College of Surgeons (ACS) recommends sales representatives act as advisors only to ensure the safe and effective use of devices and technology. Additionally, the ACS states sales representatives: should not engage in the practice of surgery, nursing, or medical decision-making; should not scrub in or be involved in direct patient contact; may be involved in remote calibration or adjustment of medical devices to surgeons and manufacturers specifications; and should be monitored and supported by the surgeon, or at the surgeon s discretion by the perioperative nurse responsible for the patient s care. 5 The Association of perioperative Registered Nurses (AORN) makes similar recommendations. 6 Most facilities do not allow sales representatives to touch patients or the devices and equipment that touch patients. Some facilities, with input from medical staff and other departments, permit sales representatives to touch devices and equipment that touch patients as long as the representatives are supervised by physicians and meet the facility s credentialing requirements. If a facility allows vendor representatives in the OR, policies and procedures should create an environment in which facility staff are comfortable questioning the presence of sales representatives and/or reporting violations. Physicians cannot assume all responsibility for sales representatives actions by simply stating, It s okay for [him/her] to be here; I accept all responsibility. Facility employees may have a duty to make reasonable efforts to care for and protect the patient, and the facility is generally liable for the acts or omissions of its employees. Facility employees, however, may be reluctant to speak-up about the presence or acts of a sales representative. Be sure to educate medical staff and facility employees about visitors in the OR and include assurances in policies and procedures for reporting patient safety violations. Additionally, the medical staff, facility employees, and sales representatives should know what is expected of them and what is unacceptable. Unacceptable conduct may be addressed in the OR visitor policy and procedure or in OR visitor guidelines, which may address such issues as: Equipment or implants brought in by sales representatives; Compliance with facility and OR policies and procedures (e.g., not using cell phones in restricted areas, respecting patients privacy rights under HIPAA, and bloodborne pathogen exposure); Signed attestations of understanding and compliance with facility policies and procedures; Leaving the OR and other patient care areas when asked; Prohibited behavior, such as vulgar or abusive language; Refraining from use of facility equipment, such as computers or telephones; Visitor contact information and a process for visitors to schedule appointments at the facility; and Sign-in at the OR desk and wearing appropriate identification at all times. 5 American College of Surgeons. Statement on Health Care Industry Representatives in the Operating Room. 6 Association of perioperative Registered Nurses. Role of the Health Care Industry Representative in the Perioperative/Invasive Procedure Setting. 2

It is not uncommon for sales representatives to provide loaner instrumentation which may be helpful to physicians and patients; but labor-intensive for the facility. Facilities should inspect the instrumentation, complete checklists and sign-off at the point of delivery, verify the availability of manufacturer processing instructions, ensure the loaner is thoroughly cleaned and sterilized at the facility, and make arrangements to return instrumentation to the vendor. Other than emergencies, most facilities require loaner instrumentation be delivered at least one full day prior to procedures so appropriate steps can be taken prior to use. Facilities should contact their professional liability insurance carrier regarding visitors or observers in the OR, especially sales representatives. Credentialing Sales Representatives Health care facilities verify credentials and grant privileges to individuals who provide care to patients. Facilities also should credential and privilege sales representatives in the OR. If a visitor s or sales representative s education in a specific area cannot be verified, the facility may consider requiring the visitor or representative participate in a facility-sponsored class or orientation. Sales representatives should be able to prove evidence of education and understanding of at least the following: Acceptable and unacceptable OR attire; Acceptable and unacceptable OR conduct; Handwashing, hygiene, and other infection control practices; OR traffic patterns; Patient confidentiality and HIPAA compliance; Radiation, fire, and electrical safety; Sterile field; and Surgical asepsis or aseptic technique. Vendors may already provide education on these and other topics, but facilities often have no evidence as to the extent of the training or when it occurred. The facility should review the vendor s education programs and require the representative complete the facility s program if uncomfortable with the vendor s programs. Facilities should also contact their professional liability insurance carrier regarding visitors or observers in the OR, especially sales representatives. If the facility does not carry professional liability coverage for the acts of OR visitors, the facility should request proof of visitors professional liability insurance. If the visitor does not carry professional liability insurance, the facility should determine whether there is other potential coverage in the event a patient alleges injury at the hands of the visitor. Such coverage may include hold harmless and indemnification agreements with the visitor s employer, or certificates of insurance from employers. OR visitors health status should also be considered. Just as a facility employee must provide results of a current tuberculosis test or immunity to hepatitis B, so should a visitor in the OR. Visitors with signs of illness such as a fever, rash, runny nose, or other evidence of transmissible disease should not be allowed in the OR. Many facilities also require background checks of sales representatives. Privacy & Confidentiality When Visitors are Present Facilities are ethically and legally obligated to protect patients privacy. Many facilities describe their ethical duty in a patient bill of rights posted throughout the facility or campus and provide a copy to the patient and family. The American Hospital Association s (AHA s) Patient Care Partnership document addresses what patients can expect during their hospital stay, including protection of their privacy. 7 7 American Hospital Association. The Patient Care Partnership. (2003) http://www.aha.org/aha/content/2003/pdf/pcp_ english_030730.pdf (accessed June 10, 2010). 3

Federal and state laws also protect patient privacy. The federal Health Insurance Portability and Accountability Act is just one example. Additionally, state laws generally protect patients confidentiality and/or privacy. Permission for Visitors & Informed Consent The AHA s Patient Care Partnership document compels facilities to identify those involved in patients care. To avoid offending patients and subsequent lawsuits, facilities should obtain patients permission to have visitors such as sales representatives present during care (see Visitors in the Operating Room Cases, Case Study Four, on page 5). As we all know, physicians have an obligation to inform patients of the risks, benefits, complications, and reasonable alternatives to surgical procedures. While the presence of a visitor is not a risk of a surgical procedure, the informed consent discussion is an ideal time for physicians to discuss potential visitors in the OR especially sales representatives. Physicians should explain the visitor s purpose, role, and level of involvement, including whether a sales representative will handle a device or equipment that may be used on the patient. Informed consent conversations are usually documented in progress notes and with the use of consent forms (which can be of significant value in defending allegations of lack of informed consent, and breach of confidentiality or privacy allegations). Documentation should also state the patient understood a visitor would be present. Physicians should also note that the visitor s purpose, role, and level of involvement were explained to the patient. Lastly, physicians should document the patient s response and whether any questions were asked and answered. Consent forms may also include this information and serve as a supplement to the discussion note. Many facilities require OR staff to document the presence of sales representatives or other visitors in the OR record. This documentation may later serve as a witness list for facilities when investigating quality assurance issues or defending medical malpractice claims. The informed consent discussion is an ideal time for physicians to discuss potential visitors in the OR... Physicians should explain the visitor s purpose, role, and level of involvement. Personal Electronic Devices A New Kind of Visitor in the OR? There was a time when visitors in the OR were nursing or medical students or young individuals who expressed an interest in medicine. As medical technology progressed, sales representatives became the most common OR visitors, assisting physicians with new devices, medications, and procedures. Now, as personal technology has evolved, visitors may also include cell phones or laptop computers. Last year, surgeons in Detroit twittered during surgery and posted a video of the surgery on YouTube. During the procedure, the surgeon mentioned the kidney tumor was large and that the case was difficult. Simultaneously, an assisting surgeon twittered that the surgeon stated the tumor was so big he would have to perform a radical nephrectomy. Minutes later, however, the surgeon decided he could remove just part of the kidney. Even clamp times were reported on Twitter. Since then, physicians have been twittering about everything from joint replacements to laser resurfacing, espousing the educational aspects of twittering for other physicians and potential patients. The patient reportedly recovered from surgery without any problems. But, what if there had been a problem? Would the clamp times reported on Twitter have been compared to the clamp times recorded in the OR record? Would the times have matched? Would the timing and content of the operative note have matched the tweets? In this surgery there were in a sense two medical records, and the two recordings of the procedure must be consistent. Continued on page 6 4

(Continued from page 4) CASE STUDIES: Visitors in the Operating Room CASE ONE During an endometrial ablation, a sales representative advised the physician on how to measure the thickness of the uterine wall. The sales representative and the physician incorrectly calculated the thickness, and the patient suffered thermal burns to the sigmoid colon and a perforated uterus. Fortunately for the physician and hospital, the patient s federal lawsuit focused on the device manufacturer and its representative. In an opinion dismissing the product liability lawsuit, the judge noted the patient had a potential state negligence claim (Adkins v. Cytyc Corp., et al., 2008 WL 2680474 (W.D. Va.)). CASE TWO In another case, a sales representative removed a plate press from the shelf and opened the instrument for the sterile field. The circulating nurse, preoccupied with checking blood transfusion information, later found holes in the outer wrap indicating a break in sterile technique. (Pennsylvania Patient Safety Reporting System. Healthcare Industry Representatives: Maximizing Benefits and Reducing Risks. Patient Safety Advisory 3, no. 1 (2006): 13-19, http://patientsafetyauthority.org/advisories/advisorylibrary/ Pages/Home.aspx (accessed June 10, 2010)) CASE THREE During cosmetic surgery a plastic surgeon used laser settings recommended by a sales representative. The patient subsequently sued the manufacturer, the sales representative, and the surgeon for severe facial scarring and skin discoloration. The manufacturer was dismissed but the surgeon settled with the patient. The judge noted, in his opinion dismissing the manufacturer, that it is indisputably the physician s responsibility to exercise clinical judgment and to determine the appropriate settings (Chamian v. Sharplan Lasers, Inc. et al., 2004 WL 2341569 (Mass.Super.)). CASE FOUR A breast cancer patient sued a pharmaceutical company and her oncologist for invasion of privacy and lack of informed consent when she discovered the sales representative (who had been introduced as a person who was looking at the oncologist s work) was not a medical professional. The representative was present during the patient s breast and abdominal exam, in which she was nude from the waist up. The case was ultimately settled (Sanchez-Scott v. Alza Pharmaceuticals et al., 86 Cal.App.4th 365 (2001)). 5

PRSRT STD US POSTAGE PAID PROASSURANCE 48924 ProAssurance Indemnity Company, Inc. 100 Brookwood Place, Suite 300 PO Box 590009 Birmingham, AL 35259-0009 800.282.6242 ProAssurance Casualty Company 2600 Professionals Drive PO Box 150 Okemos, MI 48805-0150 800.292.1036 ProAssurance National Capital Insurance Company 1115 30th Street, NW Washington, DC 20007 800.613.3615 ProAssurance Wisconsin Insurance Company 1002 Deming Way Madison, WI 53717 800.279.8331 Key Considerations is published three times a year. Lizabeth F. Brott, JD, Regional Vice President Risk Management Services Karen Everitt, JD, Regional Vice President Risk Management Services ProAssurance Indemnity, ProAssurance Casualty, ProAssurance National, and ProAssurance Wisconsin are subsidiaries of ProAssurance Corporation. If you have a change of address, please notify the company through which you are insured. This newsletter is not intended to provide legal advice, and no attempt is made to suggest more or less appropriate medical conduct. Find risk management articles and information archived on our web site at http://www.proassurance.com/riskmanagement/news.aspx ProAssurance Group is rated A (Excellent) by A.M. Best. For individual company ratings, visit www.proassurance.com. Printed on recycled paper. Copyright 2010 by ProAssurance Corporation Continued from page 4 Cell phone cameras have also made it much easier for anyone in a facility (physicians and visitors alike) to record pictures and conversations, with or without patients or facilities knowledge or consent. Conversations involving disclosures of unexpected outcomes have become one of the preferred health care subjects to record by cell phone. Health care facilities should address potential consistency and privacy issues associated with electronic communications. Most facilities restrict the use of cell phones in areas relying on equipment that is susceptible to electronic interference, i.e., intensive care units, ORs, etc. Some facilities prohibit cell phone use anywhere in the facility. Initially, electronic interference was the primary driver of these restrictions. When cameras became a common feature of cell phones, patient confidentiality took a front seat along with concerns about interference. Conclusion As access to health care information increases, patients will not only want to know who is in the room with them, but they may demand to know. As health care technology advances, facilities can expect to see new uses of technology that were never anticipated. Visitors will not go away; they will only multiply. Facilities should be ready with policies and procedures addressing these issues. 6