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Compliance In Focus
Posted by John Lehmann on Tue, Jan 3, 2012

Have You Been Asked to Provide Vendor Credentials?

Today there is no national standard for the competence or credentials of healthcare vendors. There is no specific requirement for licensure, certification, registration, or education of healthcare vendors. However, the Joint Commission recognizes a few standards that affect anyone who may directly impact the quality and safety of patient care. Clinical monitors are not directly involved in patient care, but we can have impact on the safety and quality of the care of patients being treated in clinical research trials. In fact, GCP is our standard for ensuring data is accurate and credible and that trial subjects are protected from harm. Because of this influence, some healthcare institutions are considering monitors as healthcare vendors. Thus we are faced with the same dilemma the pharmaceutical and medical device representatives are dealing with at this time – vendor credentialing.

Vendor credentialing is becoming more and more popular as healthcare institutions strive to become accredited by meeting the standards set forth by the Joint Commission. The ones pertinent to vendor credentialing include: EC.02.01.01 – Accredited health care organizations need to be aware of, identify , and manage safety and security risks, RI.01.01.01 – accredited health care organizations need to ensure patient rights are respected, and IC.02.01.01 – accredited health care organizations must ensure infection control precautions and procedures are being followed.

As monitors visiting many different healthcare facilities around the country, we are bound to visit healthcare facilities that consider us outside vendors. No matter how or what we say to the security guard or registration desk personnel we are told we must provide certain credentials to gain access to the hospital. We must comply with their vendor credentialing policies or we are not welcome. Vendor credential requirements are institution specific and are developed by each healthcare institution individually. What is required at one may be quite different than what is required at another. Certain facilities may require no verification at all. Some hospitals may internally process vendor credentials, while others might use a Credentials Verification Organization (CVO), such as Vendormate or Reptrax. Some common requirements include up-to-date immunization records (TB, Influenza, Hepatitis B, MMR, and Varicella), a background check, verification of general liability insurance, and verification of any required training (HIPAA, hospital safety, blood borne pathogens & infection control, and/or aseptic technique).

The credential verification process can have a major impact on clinical trials – delays in monitoring, increased costs, or difficulty in assigning staff to sites because of certain restrictions. This is a hot topic -- it is being discussed at the ACRP Global Conference in 2012 – “Monitors – Since When Did We Become Vendors?” Have any of your sites insisted that you register as a vendor either internally or with a third party CVO? How is your organization handling the various requirements?

Topics: john lehmann, Monitors, Clinical Research

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