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Once the Board of Directors makes the final determination on a laboratory’s accreditation application, the ICAEL will advise each lab of the decision via a personalized notification letter. This letter, sent to the Medical and Technical Directors, is tailored specifically to explain the accreditation decision and when required, to request any additional documentation to further support adherence to The ICAEL Standards. A separate decision is made for each application section (i.e., Organization, Adult Transthoracic, Adult Transesophageal and Adult Stress) and the notification letter will incorporate all decisions.

Upon receipt of the decision letter, laboratory personnel should analyze the letter to sort out the information contained therein. The document IAC Accreditation Program Policies and Procedures, published on the ICAEL website, explains the accreditation process and the decisions that can be made on the various testing sections. If the notification letter identifies areas of non-compliance with The ICAEL Standards, staff members should refer to the current version of the Standards [available at www.icael.org], examine the original studies and application materials for deficiencies that have been outlined in the letter, and implement changes that bring their practices into compliance. At that time, the laboratory would be equipped to submit any additional material requested, referred to as delay material.

Outlined in this article are the various accreditation decisions that are rendered by the Board, as well as guidelines for interpreting the notification letter.

ACCREDITATION DECISIONS

1. Grant

A laboratory to whom accreditation is granted has demonstrated substantial compliance to The ICAEL Standards. This laboratory’s notification letter will be accompanied by a portfolio containing the official certificate bearing the laboratory’s name and area(s) of testing in which the accreditation is granted, a press release, and a CD containing the ICAEL Accredited Laboratory logo. The notification letter describes the contents of the portfolio, explains proper usage of the logo, lists staff contact information and advises laboratories of their responsibility to notify the ICAEL of changes in laboratory name and address, Medical Director, or Technical Director.

2. Provisional Grant

Effective in 2007, the Board of Directors added a new decision pathway called a provisional grant, to recognize first-time applicant laboratories who are moving toward but have not yet achieved full compliance in three areas of the Standards: adequate quality assurance, sufficient Continuing Medical Education credits, and a credentialed Technical Director. The notice of a provisional grant advises laboratories that accreditation has been awarded for one year (rather than three years), despite lack of compliance in one or more of the above three areas. Award of a provisional grant indicates that the laboratory succeeded in demonstrating substantial compliance in all other areas of the Standards. The letter notes the specific areas of non-compliance and the applicable Standard, and requests evidence of adherence to the Standard. The accreditation portfolio and other information is included as described above; however, the certificates will include expiration dates one year from the month of the final Board review.

3. Delay

A laboratory whose accreditation is delayed will receive a notification letter containing this statement: The decision for the [testing section] application has been delayed for the following reasons. The letter notes the reasons for the delay (i.e., areas of non-compliance with The ICAEL Standards), and references the corresponding standard. Delayed laboratories must submit additional documentation to demonstrate compliance with the Standards. These requested items will be listed beneath the following statement: In order to rectify the above issues, please submit the following documentation.

For example, a delay letter may contain the following language:

Adult Transthoracic

The decision for the Adult Transthoracic application has been delayed for the following reasons:

• The representative aortic stenosis cases did not demonstrate complete Doppler evaluation. (ICAEL Standards, Part II, Section 3.2.2.C.2)

In order to rectify the above issues, please submit the following documentation:

• One additional transthoracic echocardiogram for each sonographer that performs transthoracic echocardiograms in your laboratory. Each must be a case of aortic stenosis (gradient > 2 m/s) that demonstrates multiple interrogation of the aortic valve using the dedicated CW (non-imaging) probe. Please include the final, signed reports and any technical worksheets that may have been completed in the course of the examination.

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