Vendor credentialing: One down, 49 to go
Edition: July 2012 - Vol 20 Number 07
One down, 49 to go. That’s how Shawn Walker of Bay State Anesthesia summed up the Indiana Hospital Association’s work in drawing up recommended standards for vendor credentialing for its members. She made her comments at the recent annual conference of IMDA, the association for specialty medical distributors.
For the first time, there may be a hint of light at the end of the tunnel for vendors wrestling with expensive and duplicative vendor credentialing standards, said Walker, who has been the association’s point person on the vendor credentialing issue for several years. She cited not only the work of the Indiana Hospital Association, but a recent clarification about credentialing from The Joint Commission, ongoing work by AdvaMed, and a proposed set of credentialing standards from a major IDN.
Hospitals originally pursued credentialing in order to ensure patient health, safety, confidentiality and conformance to government guidelines, said Walker. “But they were under the impression that Joint Commission required that non-contract employees be credentialed, and they interpreted that to mean sales reps.” Many vendors believe hospitals also seized upon credentialing as a way to limit reps’ access to clinicians.
Some hospitals and IDNs set up their own credentialing systems, but many others turned to a growing number of third-party credentialing companies. “Since then, vendor credentialing has evolved into a huge market,” said Walker, adding that third-party credentialing firms claim hundreds of thousands of reps in their databases.
A many-faceted thing
The problem for suppliers is many-faceted. For one, the cost of credentialing is borne by distributors and manufacturers, not hospitals. Second, the cost to vendors of getting their reps credentialed grows along with the number of facilities they call on and the number of vendor credentialing firms with which they have to deal. Third, the requirements of credentialing vary from hospital to hospital; there are no standards. And fourth, the criteria for credentialing have multiplied, increasing cost to the entire industry in terms of time and money, and actually presenting some threats to patient safety.
“The more hospitals ask you to read and sign off on, the less likely the rep is to remember it all,” said Walker. “That can present repercussions.” What’s more, there have been reports of service personnel being denied access to certain areas of the hospital because they lacked credentials.
Several years ago, supplier organizations, including AdvaMed, a trade association for medical products manufacturers, worked with provider groups to try to iron out industry standards, said Walker. But the economic downturn and then healthcare reform forced the issue to the back burner. “But it’s starting to be addressed now,” she added.
Indiana Hospital Association
Meanwhile, the Indiana Hospital Association has drawn up a set of recommended vendor-credentialing guidelines for its members to consult in an effort to gain some statewide consistency in their credentialing requirements. (At press time, the IHA was preparing to post the guidelines on its website, www.IHAconnect.org.)
“Representatives of medical device manufacturers approached the IHA with concerns about inconsistency in the policies and practices hospitals require of them,” explains Kathy Wallace, director of performance improvement. Some examples: repeat PPD (tuberculosis skin) tests, duplicative training in life safety code issues and repeat criminal background checks.
“The companies sought a solution whereby they can comply with the necessary medical tests, background checks and training required by the various regulatory bodies but to do so in a manner in which the requirements will not have to be unnecessarily repeated, and their personal medical and background information will be safely held,” she says. Vendors initially sought a legislative solution to address the situation. “While the IHA opposed the legislation, we understood their concerns and initiated meetings with them to find a mutually beneficial solution.”
So last year, the IHA assembled a task force consisting of eight hospital CEOs from across the state, representing various sizes of institutions. “Our goals were to provide clear interpretation of regulatory and accrediting body requirements, and provide guidance to hospitals regarding a standard practice for vendor credentialing,” says Wallace. What followed was a series of meetings involving the CEOs, vendor representatives, supply chain executives and risk managers. “At each step along the way, we received input and tweaked our original recommendations,” says Wallace. Consensus was reached, and the Indiana Hospital Association board passed a resolution encouraging facilities to adopt standard guidelines.
“We found common ground much sooner than we both thought might happen,” says Wallace, referring to vendors and hospital representatives. “I think it relates back to our agreement to work as partners and understand each other’s needs.”
The task force did discuss vendors’ desire for a “universal passport,” that is, one set of standards and one pass that could gain them entrance into any hospital. “We understood that requiring individual [sales reps] to undergo multiple tests and/or complete extremely similar requirements for every hospital across the nation just increases the cost of supplies,” says Wallace. “That being said, every organization will have some individual requirements that must be clearly understood and acknowledged by [sales reps] in order to maintain the safety of the patients. This might include something as simple as understanding the emergency codes and exit routes. Maintaining the safety of the patient and those within our facilities is our first concern.”
The guidelines address the following areas:
• Employment verification.
• Liability insurance.
• Criminal background check.
• Training in bloodborne pathogens and OR protocol (for reps in sterile areas).
• HIPAA training.
• Training in an applicable code of ethics.
• Product training/competency.
• Fire safety training.
• Training in product complaints and medical device reporting requirements.
The association concluded that the following need not be included in the recommended requirements:
• Confidentiality declaration.
• Conflicts-of-interest documentation.
• False claims.
• Gift disclosure form.
• Non-exclusion documentation (OIG).
• Office of Medicaid Inspector General (OMIG).
• Business associates agreement.
• Substance abuse testing.
• Electrical safety training.
• National patient safety goals.
• Professional certification/state licensure.
• Tissue/bone rep FDA registration/approval.
“Overall, the reaction from members has been very positive,” says Wallace. The hospital association has committed to meet jointly with the vendor community on a regular basis to review concerns from both sides. Supply chain executives will be included in those discussions.
The Joint Commission
In April, The Joint Commission clarified its stance toward vendor credentialing by publishing in April a “Frequently Asked Question” relevant to the issue. The organization states in the FAQ that it does not require credentialing of sales reps (or “health care industry representatives,” which is the term The Joint Commission uses for sales reps.). Rather, its primary concern is the competence of sales reps calling on hospitals, particularly those who have an impact on patient care, or who offer training and guidance on the use of medical devices.
Much of the credentialing being done today on behalf of hospitals and hospital systems addresses such things as adherence to infection control protocols, criminal background, etc., explains Robert Wise, M.D., medical advisor to the Division of Healthcare Quality Evaluation at The Joint Commission. “While these are important issues to anybody coming into a hospital, these areas do not help determine if the rep is qualified to train and advise clinicians on products and procedures.”
To that end, Wise and others at The Joint Commission held discussions with industry associations, including AdvaMed, about how vendors establish the competency of their reps in the field. “As we looked deeper, we verified that the people being sent [into hospitals] are in fact undergoing some type of internal training process,” says Wise. “The problem is, the demonstration of competency is never made by a disinterested third party, only by the party giving the training, that is, the company itself.” Nor at this time did it seem that any independent certification of competency was forthcoming. Given that, hospitals will continue to have difficulty making an independent judgment of the reps’ competency, he says.
In the FAQ, The Joint Commission cites minimum standards healthcare organizations should address for what it refers to as “non-licensed, non-employee individuals,” including sales reps:
• Ensure that patient rights are respected, including communication, dignity, personal privacy and privacy of health information.
• Obtain informed consent in accordance with organization policy.
• Implement infection control precautions.
• Implement patient safety program.
“Accredited health care organizations may choose to apply other Joint Commission standards and/or more stringent requirements for these individuals as they see fit,” says the FAQ.
Joint Commission FAQ on vendor credentialing
The Joint Commission on April 25, 2012, published the following “Standards: Frequently Asked Question” regarding credentialing of healthcare industry sales reps, whom the organization calls “health care industry representatives, or HCIRs.
What are The Joint Commission’s expectations regarding non-licensed, non-employee individuals in health care organizations, including health care industry representatives (HCIRs)?
The Joint Commission, similar to organizations themselves, has expectations regarding anyone entering a health care organization. In order to maintain patient safety, accredited health care organizations need to be aware of who is entering the organization and their purpose at the organization (EC.02.01.01, EP 7). Accredited health care organization leaders need to also make sure they oversee operations and that responsibilities are assigned for administrative and clinical direction of programs, services, sites, and departments (LD.04.01.05, EPs 1 and 3); this includes processes for knowing who is entering the organization and their purpose.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
• Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01, EPs 4, 5, and 7), and privacy of health information (IM.02.01.01, EPs 1 and 2)
• Obtaining informed consent in accordance with organization policy (RI.01.03.01, EPs 1, 2, and 13)
• Implementation of infection control precautions (IC.01.01.01, EP 1)
• Implementation of the patient safety program (LD.04.04.05, EP 1)
• For non-employees brought into the organization by licensed independent practitioners, there are two additional requirements regarding qualifications and competence of these individuals (HR.01.02.05, EP 7 and HR.01.07.01, EP 5)
***This requirement does not apply to health care industry representatives, as they are not under the direction of a licensed independent practitioner
Please note that The Joint Commission requirements cited above are the minimum standards organizations should address for non-licensed, non-employee individuals. Accredited health care organizations may choose to apply other Joint Commission standards and/or more stringent requirements for these individuals as they see fit.
NOTE: The Joint Commission has received many questions relating to credentialing requirements for HCIRs. While The Joint Commission does not require credentialing of these individuals, some professional organizations are recommending specific credentialing requirements for HCIRs. For more information on what the industry is recommending as it relates to credentialing of HCIRs, you may want to contact AdvaMed whose website is www.advamed.org.
EDITOR’S NOTE: To view the FAQ, go to http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFAQChapterId=66&StandardsFAQId=410.