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As part of the IAC accreditation process, applicant facilities could potentially be required to undergo a site visit of their facility. These two words, "site visit," often spark a number of questions and concerns fromfacility and administration personnel. The following questions answer or address some of the typical questions and concerns posed to the IAC regarding a facility site visit.
What is a Site Visit?
A site visit is an on-site inspection of a facility, functions, documentation and personnel.
Why Do We Need a Site Visit?
All facilities applying for accreditation are required to sign a legal document called an Accreditation Agreement. The Accreditation Agreement states that the laboratory consents to one or more random or investigative on site visits by the IAC.
REQUIRED, INVESTIGATIVE OR RANDOM SITE VISITS
- The IAC may conduct an on-site visit for cause (an “investigative site visit”). “Cause” to conduct an on-site visit includes (but is not limited to): (a) the IAC is unable to make an accreditation determination based on the written information submitted by a facility, and (b) the IAC is investigating a complaint that a laboratory/facility has failed to adhere to IAC Standards, policies and procedures.
- Generally, site visits required at the time of the board review occur because the information supplied by the facility in the application 1) does not reflect standard practices, or provides information that is incomplete and/or unclear, and therefore may not provide an accurate assessment of the facility practices.
- Random site visits are the IAC’s means to assess continued compliance to the Standards, policies and procedures.
Who Pays For the Cost of a Site Visit?
Random site visits are paid for by the IAC. Required/investigative site visit costs are the responsibility of the facility. The IAC and its site visitors make every attempt to keep these costs to a minimum.
Who Performs the Site Visit?
Site visitors are individuals who have been trained by the IAC and meet an established set of prerequisites that include appropriate technical credentials and/or medical experience and training as required by the division Standards. Random site visits are generally performed by one individual, whereas required/investigational visits are performed by a team of two.
How Do We Know If the Laboratory Will Be Given a Site Visit?
In general both the Medical and Technical Directors of the facility will be notified of the necessity of a site visit. Random site visit notification will be sent via e-mail and investigative site visit notification will be sent via UPS signature required. Site visits are performed on an undisclosed date within three months of notification. Upon notification the facility is required to contact the IAC with normal business hours and other pertinent information.
What Do We Need to Do to Prepare For the Site Visit?
During the course of the site visit, the site visitor(s) will need access to the facility policies and procedures, quality assurance documentation, other pertinent information and patient records. In addition to the document review, the site visitors will observe patient testing/procedures.
It is also very important that the Medical and Technical Directors are available for interviews and closing discussions with the site visitor(s).
How Long Does a Site Visit Last?
Typically, the site visit will last for four to six hours.
What Happens After the Site Visit is Complete?
After the site visit is complete the findings are compiled and sent to the IAC. A review of the findings is completed and the facility is notified of the final outcome. If substantial compliance to the standards is established, the facility is not required to take any additional action. If at the time the findings are reviewed the laboratory is found to be non-compliant with the IAC division standards and/or IAC accreditation policies and procedures additional information will be requested in order to establish measures have taken place to bring the facility into compliance.
The facility will also be asked to complete an evaluation of the site visit process and the site visitor(s). The IAC anticipates that the facility will take the time to answer this questionnaire and return it, so that the site visit and visitor(s) can be assessed. This allows the IAC to carefully evaluate its site visit policies and, if necessary, implement changes to improve the process. |
