As part of the ICAEL accreditation process, applicant laboratories could potentially be required to undergo a site visit of their laboratory. These two words, "site visit", often spark a number of questions and concerns from laboratory and administration personnel. The following questions answer or address some of the typical questions and concerns posed to the ICAEL regarding a laboratory site visit.

WHAT IS A SITE VISIT?

A site visit is a pre-arranged, on-site inspection of a laboratory, laboratory functions, documentation and personnel.

THIS IS THE FIRST TIME WE HAVE HEARD OF A SITE VISIT

All laboratories applying for accreditation are required to sign a legal document called an Accreditation Agreement. The Accreditation Agreement states that the ICAEL may require a site visit as part of the application process.

WHY DO WE NEED A SITE VISIT?

There are two types of site visits, performed for two separate reasons.

RANDOM SITE VISIT

• Every laboratory applying for accreditation is the potential recipient of a random site visit. There are two random site visits performed for each application deadline. After all of the applications have been entered into the ICAEL database for a given deadline, a computer program is run that randomly selects two of the applicant laboratories from that deadline.
  
• Random site visits are performed in order for the ICAEL to compare the actual laboratory functions with the information supplied in the laboratory's application. In essence, the random site visit is the method that the ICAEL uses to assess the effectiveness and accuracy of the application; it is considered an internal quality assurance measure for the ICAEL process.

REQUIRED SITE VISIT

• A required site visit is one that the ICAEL Board Of Directors requires after the review of the application has been completed in order to gain additional information necessary to make the final accreditation decisions.
  
• Generally, site visits are required because the information supplied by the laboratory in the application does not reflect standard practices, or provides information that is incomplete and/or unclear, and therefore may not provide an accurate assessment of the laboratory practices.
  

WHO PAYS FOR THE COST OF A SITE VISIT?

Random site visits are paid for by the ICAEL. Required site visit costs are the responsibility of the laboratory. The ICAEL and its site visitors make every attempt to keep these costs to a minimum.

WHO PERFORMS THE SITE VISIT?

Pools of individuals whom have been trained by the ICAEL primarily perform site visits. These individuals are located in various areas throughout the United States and are contacted to often carry out site visits in their region of the country. Random site visits are generally performed by one individual, whereas required visits are performed by a team of two.

HOW DO WE KNOW IF THE LABORATORY WILL BE GIVEN A SITE VISIT?

The laboratory technical and medical directors will be informed of the necessity of a site visit in written correspondence from the ICAEL. An ICAEL staff member or a site visitor will contact the laboratory by telephone to schedule a mutually acceptable date for the site visit.

WHAT DO WE NEED TO DO TO PREPARE FOR THE SITE VISIT?

The ICAEL will send the laboratory a letter that contains a schedule of what the site visitor(s) will be examining and observing during the course of the day. As well, the worksheets that the site visitors will use during the course of the visit will be sent to the laboratory, so that they can better understand what the site visitors will be reviewing.

It is also very important that the Medical and Technical Directors are available for interviews and closing discussions with the site visitor(s), and that there is patient testing scheduled to be done during the time that the site visitor(s) will be in the laboratory.

HOW LONG DOES A SITE VISIT LAST?

Typically the site visit will last for six to seven hours.

WHAT HAPPENS AFTER THE SITE VISIT IS COMPLETE?

After the site visit is complete, the site visitor(s) compile the findings and send them to the ICAEL. These findings are then reviewed by the ICAEL Board Of Directors at the next scheduled board meeting. Based upon these site visit findings and the results of the application review, the Board Of Directors will make their final accreditation decision. The lab will again receive written correspondence relaying the accreditation decisions. The laboratory could be granted accreditation at that time, and may be required to make some changes and submit some additional information documenting these changes and adherence, or there is the small chance that the accreditation may be denied. If denied, an appeal process is in place.

The laboratory will also be asked to complete an evaluation of the site visit process and the site visitor(s). The ICAEL anticipates that the laboratory will take the time to answer this questionnaire and return it to the ICAEL office, so that the site visit and visitor(s) can be assessed. This allows the ICAEL to carefully evaluate its site visit policies and, if necessary, implement changes to improve the process.

Being informed that a site visit will be part of a laboratory's accreditation process can be a stressful addition to the application process. However, when remaining open to the suggestions rendered from the findings of a site visit, many laboratories find that it can be used as a learning tool that assists in improving laboratory function, performance, and quality of patient care. It is an example of another benefit of undergoing a peer review process that can ultimately improve the laboratory.