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IAC
Newsletter
Maintaining Compliance
ACCREDITATION POLICIES, STANDARDS & THE LABORATORY'S RESPONSIBILITY
Summer 2008
Due to the pressures associated with working in the demanding environment of healthcare, often some of the additional responsibilities of having an accredited laboratory can be overlooked. When granted accreditation, all laboratories are required to adhere to the policies and standards set forth by the IAC, throughout their accreditation period. A revised, all-inclusive IAC version of these guidelines was adopted in April of this year; The IAC Accreditation Program Policies and Procedures is a comprehensive document detailing the operational guidelines by which the organization functions. The document is applicable to each of the accrediting divisions within the IAC and addresses topics ranging from the application review process to the decision appeals process. Participating laboratories are encouraged to reference this document, as published and available for download on the IAC website at www.intersocietal.org/iac/about/accredpolicies.htm.
The chart [below] outlines a few of the key elements to keep in mind in order to avoid placing a laboratory's accreditation at risk, maintain optimal communication with the IAC accrediting divisions and assist in the assurance of accurate representation of the laboratory's commitment to quality throughout the process of accreditation.
- The laboratory must notify the IAC, in writing, within 30 days, of any change in the Medical or Technical Director positions. If vacated, these positions must be filled with qualified individuals within 60 days of the change and the appropriate documentation submitted to the IAC.
- The laboratory must notify the IAC, in writing, within 30 days, of any change to the laboratory name, address, ownership, or significant change in operation.
- The laboratory must notify the IAC of changes in the email address of the Medical and Technical Directors or the general laboratory email.
- If the accreditation is expired, lapses, or is suspended for any reason, use of the Accredited Laboratory logo for that division is strictly prohibited.
- If additional sites are added to the laboratory, they are not considered accredited until a multiple site application is submitted and notification is received from the IAC. An additional site may be added at any time during the accreditation cycle, but will expire at the same time the main site accreditation expires.
- Although not required by the IAC, updating the list of mobile sites serviced by the laboratory will help in avoiding conflicts with insurance payers who routinely seek information from the IAC regarding the sites serviced by accredited mobile services. Mobile services are not considered accredited until a mobile service application has been submitted and notification is received by the IAC.
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- Accreditation is valid only for those specific testing areas granted by the IAC. Use of the accredited laboratory logo or other forms of implied accreditation status in conjunction with other testing that may be performed in the laboratory is strictly prohibited.
- Adherence to The Standards must be maintained throughout the accreditation cycle. The IAC can request additional documentation to assure continued compliance at any time. Ways to help assist in maintenance of The Standards are:
- documentation of formal laboratory / QA meeting minutes
- regular review of examinations performed by all technical staff members to assure technical quality and complete documentation in conjunction with The Standards and with laboratory protocols
- The Standards are revised periodically by each division's Board of Directors. When new standards are published, they are posted on the appropriate website and announced via a first class mailing and/or email blast to all laboratories that have previously purchased the accreditation materials. As The Standards are updated, laboratories must amend their protocols or procedures to reflect the changes and ensure that all staff members implement them.
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Reporting Changes
The obligation of accredited laboratories to ensure compliance during their accreditation is addressed within the document discussed on page 5. As part of that responsibility, every laboratory is required to notify IAC of any change in its operations that might affect accreditation, and this notification must be made within thirty (30) days. The updated Policy on Reporting Changes appears within the IAC Accreditation Program Policies and Procedures and provides examples of the types of changes which the IAC considers relevant. Sample affidavit forms for reporting changes are available from the IAC; however, laboratories may use their own affidavit formats as long as the same information and certifications are provided. Depending on the nature of the change in operations, the IAC may ask the laboratory to submit additional evidence of continuing compliance (and additional fees may apply).
One change which must be reported is a change in ownership, and accreditation cannot be transferred to a new owner unless approved by the IAC. An accreditation application is limited to one legal entity, such as a hospital or laboratory LLC (multiple sites and mobile services may be exceptions to this general rule). Accreditation is valid only for the legal entity named in the accreditation application and agreement, and this legal entity will be identified in IAC records by its Employer Identification Number ("EIN"). A dispute over ownership of accreditation sometimes arises between co-owners or during a merger or acquisition among hospitals, partners, and/or laboratory management companies. Use of the EIN reduces the need for IAC to intervene in these disputes. (Note: Labs involved in merger, acquisition, or dissolution negotiations should make sure to discuss which one entity will hold the accreditation award after the change keeping in mind the need to maintain continuing compliance with The Standards.)
Participating laboratories are reminded that IAC approval of a transfer of accreditation, by itself, does not constitute a warranty of compliance with the relevant standards. At all times, laboratories are responsible for maintaining compliance with The Standards, including having a Technical Director and Medical Director on staff whose identities have been reported to IAC.
By upholding the standards of accreditation and complying with the IAC Accreditation Program Policies and Procedures, laboratories contribute toward maintaining the integrity of the accreditation process, as well as illustrating a true commitment to quality care that defines an accredited laboratory. Laboratories with questions related to the Accreditation Agreement or any of the compliance issues described above, including reporting changes, are encouraged to review the IAC Accreditation Program Policies and Procedures document online, and to contact the IAC staff via the online directory provided on each division website or the IAC legal department at lawfirm@intersocietal.org.
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