CLINICAL PRIVILEGE WHITE PAPER

Special report 1010 CLINICAL PRIVILEGE WHITE PAPER Health care industry representatives in the operating room and other invasive and special procedure sites Background Health care industry representatives (HCIRs) within hospital premises including the operating room (OR) are individuals who promote, sell, and give training and advise on medical systems, devices, and procedures. The knowledge and expertise that these sales reps can provide about their products may make their presence in the hospital worthwhile because they are more familiar with their system, device, or procedure than the physician and the healthcare team. They are able to offer technical support. While most frequently providing services in the operating room, it is also becoming frequent practice for HCIRs to practice in other hospital and ambulatory settings including cardiac cath labs, special procedure rooms, etc. In the past, there have been instances when HCIRs in the OR have been blamed for adverse events. As a result, groups such as the American College of Surgeons (ACS) and the Association of perioperative Registered Nurses (AORN) have developed and published statements that provide guidelines to hospital senior leadership, board and medical staff leadership, and other members of the hospital leadership team for governing the presence and use of sales reps or other vendor representatives in the operating/surgical or other special procedures suites. In their statement, AORN says it believes that HCIRs, by virtue of their training, knowledge, and expertise, can provide technical assistance to the surgical team. This assistance can expedite the procedure and facilitate desired patient outcomes. However, these HCIRs, like any visitor or observer to the OR, must obtain the permission of the hospital leadership. They must also obtain informed consent from patients, which means that the patients must be told of the sales representatives permitted level of involvement and role. For HCIRs, hospital leadership should define the following Institutional Policies and Specific Procedures: Hospital policy shall be documented and establish the detailed credentialing procedure to be completed for each individual to determine if these sales reps have the proper credentials to be allowed in the OR or other special/invasive procedure rooms. The HCIRs must demonstrate that they are properly oriented to the OR or special procedure setting (all references to OR include by definition all special/invasive procedure settings), which includes knowledge of sterile fields, aseptic technique, traffic patterns, and appropriate conduct. They should also show that they have had appropriate testing and immunizations A supplement to Briefings on Credentialing 781/639-1872 1/05 1

for diseases such as tuberculosis (TB) or hepatitis and are in good health, free from any contagious disease or condition. Hospital defined procedures should be documented and required to determine whether the HCIRs have successfully completed the required training for the medical system, device, or procedure for which they are offering technical support. They should further require that a sales representative s training included experience in the OR in a mentorship program supervised by an experienced HCIR. Certificates that attest to completion of an OR protocols course and completion of company training should be added to the sales representative s file. No representative of the vendor or external sales/device manufacturer shall be allowed in the operating suite without successful completion of the hospital defined credentialing process. Additional procedural requirements should include that representatives shall - not be allowed to open sterile supplies in the surgical/operating/special procedures environment. - not have access to any patient (specific or aggregate) information outside the single case to which patient consent was obtained and this access shall be limited to a clinical, patient specific level need to know. - be required to provide proof of professional liability insurance coverage at the minimal amounts of $1 million per occurrence and $3 million annual aggregate. - be required to have documentation of an attestation of responsibility from a physician member of the medical staff for the HCIR participation in patient care. The Credentialing Resource Center (CRC) recommends that hospital leaders define the process of approval and annual reapproval of HCIRs in the hospital when companies return to their facilities to train a second generation of physicians and teams in a medical system, device, or procedure. It has been observed that companies are apt to employ more experienced sales representatives when they are introducing a new product and may not have the same high training standards for a product that has been in use for a period of time. Positions of societies and academies ACS The ACS publishes Statement on Health Care Industry Representatives in the Operating Room. The statement requires the following institutional policies and specific procedures: Institutional policies Healthcare organizations, for example, hospitals and outpatient OR facilities, should establish written policies defining the following: 2 A supplement to Briefings on Credentialing 781/639-1872 1/05

Requirements and procedures for manufacturers representatives to be present in the OR Restrictions to govern representatives activities in the OR These policies should comply with applicable state law and regulations, should be consistent with the organization s existing policies, such as those promulgated by OR and/or credentialing/privileging committees, and should include, but not be limited to, the following elements: Specific procedures Approval, which means that the institution should designate an authority for approving a representative s presence in the OR. A time frame for securing this approval also should be established. No HCIR shall enter the operating/ surgical suites without successful completion of the hospital defined approval process. Orientation, training, and credentialing of the representative, which requires that the representative should document knowledge of the following: - Patients rights and confidentiality - Appropriate conduct in the OR environment - Aseptic principles and techniques - Fire, electrical, and other safety protocols - Infection control - Background check verification as required by hospital ethics policy completed by a hospital approved entity and provided to the hospital by the sponsoring product/device company - Other applicable practices that may be related to the operation Physician approval, which requires that if the physician did not initiate the request, the physician should be notified and approve the visit prior to the operation. Consent requirements, which requires that the patient should be notified of the presence and purpose of the representative in the OR and give written, informed consent. Representative role, responsibilities, and restrictions in the OR, which requires that the representative conduct in the OR should be defined clearly in the written policy. Representatives should wear identification during their visit to the OR and/or other patient-care areas. A supplement to Briefings on Credentialing 781/639-1872 1/05 3

Representatives should not be permitted to participate directly in any procedures on the patient. Documentation, which requires that there be documentation of a representative s presence during the procedure, and the patient s consent regarding the representative s presence, should be included in the permanent medical record. AORN AORN publishes AORN Statement on the Role of the Health Care Industry Representative in the Operating Room. In the statement, AORN says it recognizes the need for a structured system within the perioperative setting for education, training, and introduction of procedures, techniques, technology, and equipment to practicing healthcare professionals. AORN further says the purpose of this statement is to affirm the valuable role HCIRs play in the care of surgical patients and to assist the perioperative team in maintaining the patient s safety, right to privacy, and confidentiality when an HCIR is present during a surgical procedure. An HCIR may be present during a surgical procedure under conditions prescribed by the facility. AORN recognizes there is a wide range of geographic and regional variations regarding the activities of the HCIR in the operating room. This statement provides general guidelines to assist the individual facility in developing policies best suited to its community standards. Along with concerns pertinent to the facility, AORN recommends that the following precepts guide policy development: Policy should be developed in collaboration with the facility s risk management and/or legal counsel to ensure compliance with applicable laws. Each facility should develop a system that addresses informed patient consent regarding the presence and role of an HCIR in the OR during a surgical procedure in both routine and emergency situations. This system should include documentation in medical records. As the patient s advocate, the RN responsible for the patient s care during the procedure is accountable for maintaining the patient s safety, privacy, dignity, and confidentiality. To achieve this, the RN should monitor the HCIR s 4 A supplement to Briefings on Credentialing 781/639-1872 1/05

activities whenever possible and facilitate the representative s service to the patient and the perioperative team during the procedure. The RN should be informed prior to the procedure that a HCIR will be present and about his or her purpose for being there. Perioperative team members are responsible for acquiring instruction on new procedures, techniques, technology, and equipment with which they are not familiar prior to their use in a surgical procedure. This instruction may be provided by the HCIR. The facility should maintain evidence of documented competencies for health care professionals, especially when introducing new procedures, techniques, technology, and equipment as required by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Each facility should develop a system that documents that the HCIR has completed instruction in the principles of asepsis, fire and safety protocols, infection control practices, bloodborne pathogens, and patients rights. Based on community standards, this may range from maintaining up-todate documentation provided by the HCIR s employing company to providing facility-specific instruction and training. The HCIR s presence and purpose should be prescheduled with the designated OR management authority and the surgeon in accordance with the facility policy. The HCIR should wear identification while in the facility. Each facility should develop a system that clearly delineates limits on the HCIR activities in the operating room based on community standards. The HCIR should not scrub in. The HCIR with specialized training may perform remote calibration to adjust devices to the surgeon s specification (e.g., pacemakers). Medical equipment and other complex devices must be reviewed and approved prior to their use by the facility s service provider. A clearly defined mechanism should exist to address departures from established policy. A supplement to Briefings on Credentialing 781/639-1872 1/05 5

CRC draft criteria When a hospital receives a request from an HCIR to be present in the OR, it should not be the first time the hospital considers whether this type of individual should be granted such permission. Hospital specific policies (see Background section above, Institutional Policies and Specific Procedures ) shall detail the required content and process for initial assessment and reevaluation. Reevaluation shall include consideration of quality and performance information as gathered by hospital quality monitoring mechanisms. The policy covering HCIRs should be drafted in advance by the board and should resolve any liability issues. In addition, the board should review federal laws, state laws, and state and local licensing requirements. Hospitals should also check to see whether state laws or regulations prohibit visitors, observers, or HCIRs in the OR. The advice of the medical staff should be considered as well as the needs of the community and the hospital s mission and strategic plan. Criteria should be in place covering qualifications, scope of practice, and physician supervisory requirements. The following draft criteria are intended to serve solely as a starting point for the development of an institution s policy regarding this practice area. Minimum threshold criteria for requesting approval to be present in the OR Basic education: Baccalaureate degree, which included such basic science courses as biology, chemistry, and physics as well as credits in human anatomy and physiology. Minimum formal training: Applicants must have successfully completed the following: An OR protocols course, which included the following: - Appropriate conduct in the OR environment - Aseptic principles and techniques - Infection control practices - Bloodborne pathogens - Fire, electrical, and other safety protocols - Patients rights and confidentiality, which included Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance strategies - Informed patient consent regarding the presence and role of HCIRs in the OR 6 A supplement to Briefings on Credentialing 781/639-1872 1/05

Training in the medical system, device, or procedure for which they are seeking approval for their presence in the OR. Training must have included experience in the OR for that medical system, device, or procedure in a mentorship program supervised by an experienced HCIR. Documentation of satisfactory results from a criminal background check at the levels of assessment as specified by hospital policy and practice. Documentation of sponsorship from an active status member of the medical staff with privileges compatible to the privileges being requested by the HCIR. Recredentialing for new products or devices as defined by hospital policy and procedure. Applicants must also comply with hospital policy and procedure with minimum content as defined by Institutional Policies and Specific Procedures. Required previous experience: Applicants must also be able to demonstrate that they have provided technical support on at least five occasions in the past 12 months for the medical system, device, or procedure for which they are seeking approval for their presence in the OR. Note: The CRC recommends that applicants should present written proof of current TB testing, hepatitis vaccination and agree not to participate in the delivery of any patient care services when symptoms of any contagious disease or condition exist. References Letters of reference must come from the director of the applicant s OR protocols training program and the director of the applicant s medical system, device, or system training program. Alternatively, a letter of reference regarding competence should come from the chief of surgery at the institution where applicants most recently provided technical support for the medical system, device, or procedure for which they are seeking approval for their presence in the OR. A letter of responsibility and sponsorship shall be provided from an active status medical staff member with privileges correlating to the services requested by the HCIR. A supplement to Briefings on Credentialing 781/639-1872 1/05 7

Bylaws and policies Failure to comply with medical staff bylaws, rules and regulations or hospital policy shall result in termination of privileges without right to appeal. All privileges are granted by the hospital board of trustees and may be rescinded by the chief executive officer, on behalf of the board, at any time based on advancement of patient care and hospital policy. Reapproval Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have provided technical support on at least five occasions in the past 12 months for the medical system, device, or procedure for which they are seeking reapproval for their presence in the OR. In addition, continuing education related to the medical system, device, or procedure for which they are seeking reapproval for their presence in the OR should be required. For more information For more information regarding this, contact: American College of Surgeons 633 North Saint Clair Street Chicago, IL 60611-3211 Telephone: 312/202-5000 Web site: www.facs.org Association of perioperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO 80231 Telephone: 303/755-6304 Web site: www.aorn.org 8 A supplement to Briefings on Credentialing 781/639-1872 1/05

Clinical Privilege White Papers Advisory Board James F. Callahan, DPA Executive vice president and CEO American Society of Addiction Medicine Chevy Chase, MD Sharon Fujikawa, PhD Clinical professor, Dept. of Neurology University of California, Irvine Medical Center Orange, CA John N. Kabalin, MD, FACS Urologist/Laser surgeon Scottsbluff Urology Associates Scottsbluff, NE Publisher/Vice President: Suzanne Perney sperney@hcpro.com Group Publisher: Kathryn Levesque klevesque@hcpro.com John E. Krettek Jr., MD, PhD Neurological surgeon Vice president for medical affairs Missouri Baptist Medical Center St. Louis, MO Michael R. Milner, MMS, PA-C Senior physician assistant consultant Phoenix Indian Medical Center Phoenix, AZ Senior Managing Editor: Edwin B. Niemeyer eniemeyer@comcast.net Beverly Pybus Senior consultant The Greeley Company Marblehead, MA Richard Sheff, MD Chair and Executive Director The Greeley Company, a division of HCPro, Inc. Marblehead, MA The information contained in this document is general. It has been designed and is intended for use by hospitals and their credentials committees in developing their own local approaches and policies for various credentialing issues. This information, including the materials, opinions, and draft criteria set forth herein, should not be adopted for use without careful consideration, discussion, additional research by physicians and counsel in local settings, and adaptation to local needs. The Credentialing Resource Center does not provide legal or clinical advice; for such advice, the counsel of competent individuals in these fields must be obtained. Reproduction in any form outside the recipient s institution is forbidden without prior written permission. Copyright 2005 HCPro, Inc., Marblehead, MA 01945. A supplement to Briefings on Credentialing 781/639-1872 1/05 9

Approval request form Healthcare industry representatives in the operating room To be eligible to request approval to be present in the OR, HCIRs must meet the following minimum threshold criteria: Basic education: Baccalaureate degree, which included such basic science courses as biology, chemistry, and physics and credits in human anatomy and physiology. Minimum formal training: Applicants must have successfully completed the following: - An OR protocols course, which included the following: Appropriate conduct in the OR environment Aseptic principles and techniques Infection control practices Bloodborne pathogens Fire, electrical, and other safety protocols Patients rights and confidentiality, which included HIPAA compliance strategies Informed patient consent regarding the presence and role of HCIRs in the OR - Training in the medical system, device, or procedure for which they are seeking approval for their presence in the OR. Training must have included experience in the OR for that medical system, device, or procedure in a mentorship program supervised by an experienced HCIR. - Documentation of satisfactory results from a criminal background check at the levels of assessment as specified by hospital policy and practice. - Recredentialing for new products or devices as defined by hospital policy and procedure. Applicants must also comply with hospital policy and procedure with minimum content as defined by Institutional Policies and Specific Procedures. Required previous experience: Applicants must also be able to demonstrate that they have provided technical support on at least five occasions in the past 12 months for the medical system, device, or procedure for which they are seeking approval for their presence in the OR. Note: The CRC recommends that applicants should present written proof of current TB testing and hepatitis vaccination and agree not to participate in any patient care services when symptoms of any contagious disease or condition exist. References: Letters of reference must come from the directors of the applicant s OR protocols training program and the director of the applicant s medical system, device, or system training program. Alternatively, a letter of reference regarding competence should come from the chief of surgery at the institution where applicants most recently provided technical support 10 A supplement to Briefings on Credentialing 781/639-1872 1/05

for the medical system, device, or procedure for which they are seeking approval for their presence in the OR. A letter of responsibility and sponsorship shall be provided from an active status medical staff member with privileges correlating to the services requested by the HCIR. Reapproval: Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have provided technical support on at least five occasions in the past 12 months for the medical system, device, or procedure for which they are seeking reapproval for their presence in the OR. Medical staff bylaws and hospital policies: Failure to comply with hospital policy or medical staff bylaws, rules and regulations may result in immediate termination of privileges without any process of appeal. In addition, continuing education related to the medical system, device, or procedure for which they are seeking reapproval for their presence in the OR should be required. I understand that by making this request I am bound by the applicable bylaws or policies of the hospital, and hereby stipulate that I meet the minimum threshold criteria for this request. Applicant s signature: Typed or printed name: Date: A supplement to Briefings on Credentialing 781/639-1872 1/05 11

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