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As part of the ICANL accreditation process, applicant laboratories have been required to undergo a site visit of their laboratory. Recently the ICANL Board of Directors has made changes to the site visit program, which are now in effect. A percentage of the applications received each quarter is now randomly selected to receive a site visit. Laboratories that are randomly selected are contacted by an ICANL site visitor to select a mutually agreeable date to conduct the site visit.

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 ICANL 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 by a technologist or physician.

Why do we need a site visit?

A site visit is required by the ICANL Board Of Directors, in addition to the review of the application, in order to gain additional information necessary to make the final accreditation decisions.

Who pays for the cost of a site visit?

The costs of the site visit are included in the application fee.

Who performs the site visit?

Pools of individuals trained by the ICANL perform site visits. These individuals are credentialed technologists and/or physicians and are currently working in ICANL accredited laboratories.

What do we need to do to prepare for the site visit?

The ICANL will send the laboratory a letter that contains a schedule of what the site visitor will be examining and observing during the course of the day. Typically the following will be closely reviewed and/or observed:

  • administrative policies and procedures manuals (i.e.: clinical procedure protocols, equipment quality control, radiation safety and administrative)
  • radiation safety documents
  • dosage records
  • results of prior NRC and state inspections (if any) with any corrective actions undertaken, if required
  • training and in-service records for technologists
  • technical procedure manual
  • gamma camera and other equipment quality control records (and phantom studies, if available)
  • quality assessment policies and documentation
  • any other pertinent documents related to the operation of your facility

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, and that there is patient testing scheduled to be done during the time that the site visitor will be in the laboratory.

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 site visitor compile the findings and send them to the ICANL. These findings are then reviewed by the ICANL Board Of Directors at the next scheduled board meeting, along with the reviews of the application. 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. The ICANL anticipates that the laboratory will take the time to answer this questionnaire and return it to the ICANL office, so that the site visit and visitor can be assessed. This allows the ICANL to carefully evaluate its site visit policies and, if necessary, implement changes to improve the process.


Scheduling and undergoing a site visit as 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.

 

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Beginning with the July 2, 2007 application deadline, the ICANL will randomly select a statistically valid percentage of the applications received each quarter and require only that select group to undergo a site visit.


Alternatively, the applicant laboratories not selected for the site visit are instead required to submit relative policies and documentation. These laboratories not selected for a site visit will receive a letter outlining the information needed for this audit. The submitted documentation is reviewed by the ICANL and contributes to the laboratory's accreditation decision. Failure by the laboratory to provide the ICANL with such documentation within 45 days of such request during the accreditation review process will result in postponement of the accreditation decision.

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