Safety in the Perioperative Setting: Vendor Support

Chapter 26 Safety in the Perioperative Setting


Vendor Support



Peggy Camp, MSN, BSN, RN


Managing patient safety in the perioperative setting continues to be a major challenge. Managers of surgical services departments develop and implement multiple equipment-related and safe practices policies and procedures to minimize safety risk for the staff and surgical patients. In addition, managers must develop and implement policies that balance the need for industry representatives (vendors) in the operating room (OR) and other high-risk procedural areas within a facility (e.g., cardiac catheterization laboratory, endoscopy unit, interventional radiology departments). It is an accepted practice to allow vendors in various procedural areas, including the OR. This is especially important when the physicians and staff are unfamiliar with a specific supply item or piece of equipment (ECRI, 2007).


As professional caregivers, the perioperative staff and physicians have a responsibility to ensure that patient safety is maintained at all times regardless of the setting. Patient safety continues to be an area that regulatory agencies, government agencies, and professional associations closely track and research in an effort to identify practices that can be implemented to minimize untoward patient outcomes. “Healthcare is one of the last, complex high-technology industries to adopt a systematic approach to safety and typically relies on the resolve and vigilance of individual clinicians to avoid bad outcomes for the patient” (Webster, 2005). There is no question that vendors provide the perioperative team with education and information that is necessary in these times with rapidly changing and sophisticated technology (ECRI, 2007). At the same time, the importance of controlling access to the OR is essential for maintaining a safe patient environment. It is not acceptable for vendors to be present in perioperative areas without a designated purpose. Facilities should implement controls and guidelines for vendor access, and it is important for every perioperative team member to be aware of policies governing access.


As facilities look to ensure safety in the OR related to vendor access, there are several key considerations. Every vendor must be qualified to support the equipment or supply the vendor represents. The vendor should be trained in general hospital policies and protocols such as Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations, fire safety, and aseptic practice principles. The vendor should be a reputable individual who demonstrates awareness of and follows all facility policies regarding introduction of new products. Another issue is the surgeon’s request for vendor presence in the OR. Although difficult to determine, consider if there are known financial relationships between the physician and vendor. Staff comfort level with the vendor in the room is another important aspect. Are there documented policies that identify vendor access in the OR? Consider the possibility of an increased risk for infection when outside individuals are allowed access to the OR. A defined policy on patient consent to having a vendor in the OR during a procedure is necessary. These issues need to be addressed by every facility with vendors in the OR and will be covered in detail in this chapter.



VENDOR QUALIFICATIONS



Product Knowledge and Expertise


Facility policies and procedures should identify the process to determine vendor qualifications to support the supply or equipment the vendor represents. The majority of large, nationally known vendors will have formalized education and training programs for their sales representatives. However, there is a growing number of small companies that do not have resources to provide extended training for their field representatives. In addition, many equipment or supply manufacturers contract with local companies or individuals to support their products in the clinical setting. An example of this would be a small implant company (e.g., bone, tissue, spine, trauma) that hires individuals to cover its products and that has limited resources to train those individuals on the products they are promoting.


Over the past decade the verification of vendor knowledge, skill, and expertise has been embraced in varying degrees with inconsistent requirements and expectations. Currently there are no regulatory agencies such as The Joint Commission (2009) that require facilities to implement organized systems. However, The Joint Commission (2009) expects implementation of standards that “are relevant to any individual that enters a health care organization who directly impacts the quality and safety of patient care.” These standards include the following: Standard EC.02.01.01, which states that to protect patient safety, accredited health care organizations need to be aware of who is entering their organization and what these individuals are doing in their organization; Standard RI.01.01.01, which states that accredited health care organizations need to take steps to ensure that patient rights are respected; and Standard IC.02.01.01, which states that accredited health care organizations need to take steps to ensure that infection control precautions are followed.


Given the rising concerns about patient safety and liability, many facilities are implementing clearly identified processes to control vendor access. Many facility policies and procedures require a formal request by the surgeon and/or staff before allowing a vendor into the OR. Vendor access to sell or promote products in public areas such as staff and physician lounges may not be permitted in some facilities. Many facilities have implemented a policy that if a vendor does not have a scheduled appointment, the vendor will not be permitted in any clinical area, including the OR. The unfortunate reality is that health care professionals are inundated with new technology every day. It is unreasonable and unrealistic to expect that the surgeon and perioperative team will have the knowledge, skills, and understanding to use every piece of equipment, supply, or implant in a manner that is safe and optimizes patient outcomes.


Most facilities have implemented processes requiring new product evaluation by a thorough detailed analysis before being allowed into the OR. The analysis includes U.S. Food and Drug Administration (FDA) approval for the procedure that the product is being used in, comparison with similar products already available, cost and reimbursement for the new product(s), and end-user education and support. Even with these type of controls in place, facilities may be held liable for all nonemployed individuals that participate directly or indirectly in surgical procedures. In a highly publicized case in New York, a sales representative was in the OR during a laparoscopic procedure. The patient died during the procedure, and the facility was cited on several counts, including an allegation that the sales representative operated the equipment during the procedure (Murphy, 2001).


Most state laws dictate that only licensed physicians can perform surgery; although physicians may use assistants, vendors do not (generally) have the proper training to be legally recognized assistants (Pennsylvania Patient Safety Authority [PSA], 2006). This presents questions about the level of involvement and facility/surgeon liability in procedures where implants are used. Specifically in spine, orthopedic, trauma, and plastic surgery, the vendor is generally in the OR in the role of advising and collaborating with the surgeon on the proper implant size and placement. The continued growth of technology and advancements in the implant arena makes it difficult, if not impossible, for the surgeon to be knowledgeable about every system and implant that could be used—this fact further complicates the situation.


There are also safety, liability, and ethical concerns if the vendor is denied access. Is the patient placed at a greater risk than if the vendor is allowed to be present? Hospitals have documented that vendors in the OR can be a distraction that may contribute to adverse patient outcomes. In one case the patient was undergoing bilateral knee replacement surgery. The vendor handed the surgeon the wrong knee implant, and it was placed in the patient (Maryland Department of Health and Mental Hygiene, 2007). In another case a warning light came on during a gynecologic procedure. The vendor turned off the alarm, and the patient had a bowel burn requiring emergency surgery a few days later (Smart v Johnson and Johnson et al, 1998). Although these may be isolated incidents, they support the need for advance review and approval of all new products. Allowing vendors in the OR and limiting access both have pros and cons. Although new product review and approval are not going to eliminate risk and untoward outcomes, the process will help to minimize some of the patient safety risks and concerns.


Policies and procedures for vendor representatives in the OR must be well-defined and include the following:



1. Defined oversight for all vendor access


2. Policies and procedures requiring documentation of appropriate training and education on the product the vendor is representing and promoting


3. Policies and procedures to ensure appropriate training and education on internal processes (e.g., aseptic technique, fire safety, electrical safety, HIPAA, and infection control)


4. Policies and procedures requiring documented evidence that the vendor has been provided with a copy of the expectations for presence and performance at the facility



Personal and Professional Competencies


Health care providers and facilities have the responsibility to ensure that nonemployed individuals are competent to support a safe patient environment while in the facility. To accomplish this, vendors must meet specific criteria before being given access into the facility. Vendors must be able to validate that they are trustworthy, honest, have integrity, and are professional in addition to having clinical competencies. For facilities that have formal credentialing processes in place, this information is generally included in the application process. The first step should be to obtain a background check, which can be done by the credentialing agency or the facility or obtained from the vendor parent company. Another initial verification should be that the parent company meets federal regulations (e.g., Office of Inspector General [OIG], U.S. General Services Administration [GSA] Exclusion check). Screening vendors for criminal or malpractice violations is critical, given that they are in close proximity to patients, and failing to produce evidence of a solid personal and professional history should be a cause for concern. Many facilities do not approve vendor access if the vendor and/or parent company fails to pass these requirements.


Once the vendor and parent company have satisfied the background and OIG/GSA requirements, they can move forward to verify credentials for the individual’s clinical competencies. Unfortunately, facilities can ask for verification of the vendor training and education, but it is up to each company to develop vendor training programs because there are no universally accepted training methods. There remain great variations in the programs. For example, some companies have training programs that are several weeks long, whereas others are only a few days. It is expected that all vendors must have the ability to support the product and equipment and adhere to policies and procedures of the complex OR environment. Many companies hire nurses and scrub technicians to support their sales force; it is important to verify that the “clinical company resource” individuals are also required to meet the same criteria as the sales representatives. Again, it is not safe to assume that an individual is competent just because the individual has practiced as a clinician in the past. For this reason, the OR director, manager, or designee should complete a formal or informal assessment of the vendor or clinical support person’s ability to perform while in the OR. In addition to the initial assessment, the facility may request information that includes the following:



1. A letter of competence from other institutions where the vendor is credentialed.


2. Documentation of training that is specific to the product or equipment in the following areas:


a. The medical system, device, or procedure for which approval is sought, which should include evidence of initial participation in a mentorship program supervised by an experienced vendor or company trainer and evidence that the individual has provided services or technical support on at least (X) occasions in the past (X) months for the product being represented

b. Working in the OR or other procedural setting, which includes the following: 

(1) Evidence of completion of an OR protocols course

(2) Training in the Universal Protocol (i.e., time-out and verification of correct patient identity, correct side and site, agreement on the procedure to be done, correct patient position, and availability of correct implants and any special equipment [including any brought by the vendor] or special requirements)

(3) Training in aseptic principles and techniques, including any cleaning or sterilization requirements for any device or equipment brought by the vendor, including any requirements related to disposal, storage, or reprocessing of single-use devices

(4) Proper surgical attire

(5) Fire prevention related to heat sources

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Aug 5, 2016 | Posted by in ANESTHESIA | Comments Off on Safety in the Perioperative Setting: Vendor Support

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