ASHI Accreditation
Appeals Process - Instructions for Filing an Appeal

Background and Introduction

The ASHI Laboratory Accreditation process involves a multilevel evaluation by a Commissioner, Co-Chair, and, on alternate years at a minimum, an on-site Inspector. The final review is performed by and the outcome of the evaluation determined by the entire Accreditation Review Board that is comprised of the Program Director who serves as a non-voting chair (except when a tie-breaker is needed), the Co-Chairs, and the Commissioners. The structure of this process provides a high assurance of a thorough, fair, and impartial evaluation of compliance with the minimum standards that must be followed to assure reliable test results. Nonetheless, when accreditation is denied, revoked, suspended or limited, the applicant shall have the opportunity to appeal the decision. 

Exceptions: Applicants who refuse to cooperate with reasonable requests for information, data, or documentation; who deny an inspector access to the laboratory for purposes of performing an on-site inspection; or who knowingly and willfully obstruct the evaluation process shall not have the right to appeal the Accreditation Review Board’s decision.

Description of the Process

When there is NOT a condition of immediate threat to patient care or danger to the general public, the Appeal Process occurs in two stages.

First, the Appeal Board reviews documents submitted by the applicant and the laboratory evaluation documentation to determine if an Appeal Hearing is warranted. A hearing is warranted when there is clear evidence suggesting the decision of the Accreditation Review Board resulted from bias, misrepresentation, or unavailability of critical information. If the Appeal Board determines that a hearing is not warranted, the initial decision of the ARB is upheld and the Appeal Process ends. If the Board determines that a hearing is warranted, the process moves to a second stage in which a hearing is conducted. For purposes of the hearing, the Appeal Board may request additional documentation from any members of the ARB, the inspector (s), or the applicant, which must be provided if the Appeal is to proceed. The Appeal Board will meet and will conduct interviews of relevant individuals either at the meeting site or by teleconference. Subsequent to the hearing and within 30 days of the filing of the appeal, the Appeal Board will render its decision. In cases in which the ARB has assessed there to be a threat to patient care or danger to the general public, the process must be completed within 10 calendar days of the notification of the applicant. The Appeal must be submitted within 5 days and the Appeal Board will review and render a decision within 10 days. In these cases, an appeal does not stay the decision of the ARB.

All documents associated with the hearing shall remain confidential. The applicant shall receive a summary statement of the basis of the Appeal Board’s decision. If the Appeal Board upholds the initial decision of the ARB, the action of the ARB will be imposed immediately and the applicant shall be billed for all costs associated with he appeal process. These costs will include but are not necessarily limited to: phone calls, photocopying, personnel costs, shipping, legal fees. If the Appeal Board reverses the decision of the ARB, accreditation will be granted or renewed retroactive to the previous renewal.

Materials and testimony are to be limited to documentation of conditions existent at the time of the laboratory evaluation. No actions taken and no data generated subsequent to the evaluation are to be considered. The evaluation process itself is not to be evaluated but rather whether or not the findings of the ARB were correct and factual. The decision of the Appeal Board shall be final.

For an appeal application to be valid, it must contain all necessary documents and a check or money order to cover the filing fee. One-third of the filing fee is a non-refundable processing fee. If the Appeal Board finds against the applicant, part or all of the remaining two thirds of the filing fee will be applied to the cost of the Appeal Process. If the Appeal Board finds in favor of the applicant laboratory, two thirds of the filing fee will be returned to the applicant. If the application for an appeal is incomplete, the applicant will have 48 hours to submit the necessary materials or shall forfeit the right to an appeal.

Instructions for Filing an Appeal

Submit the following materials prior to the deadline for filing an appeal that was indicated on the Notice of Right to Appeal.

A. Five copies of documents providing evidence that the findings of the ARB were incorrect. These materials must be page numbered, bear the lab’s ASHI number, and be bound together in a ring binder or other system that provides reasonable assurance of maintaining the order of the documents. 

The first page of the packet must be a table of contents. 

The front of each document must indicate the citation(s) address by the information/data contained in the document. This material must be limited to information about conditions that existed at the time of review and must not contain materials that discuss actions taken or data generated subsequent to the action of the ARB.

B. A check, bank draft, or money order made payable to ASHI in the amount of $1500.

C. A signed agreement of financial obligation.

D. A written summary of no more than 2 pages in length, highlighting the bases of refuting the ARB decision.

All materials must be sent by overnight courier and must be traceable.

Send materials specified in A - D, above, to:
Melissa McElroy
Accreditation Manager
ASHI Accreditation Office
90 West County Road C
Suite 300
St. Paul, MN 55117
(651) 487-2806  /  Fax: (651) 489-3387
melissa@cmehelp.com