ALLEGATIONS CONCERNING ACCREDITED LABORATORIES AND
THEIR EMPLOYEES
1. Applicability of Procedure
Compliance monitoring is one way by which ASCLD/LAB verifies that accredited laboratories maintain accreditation standards. The Board, on a case-by-case basis, will review any information suggesting non-compliance with the standards by an accredited laboratory.
This procedure applies to the review of information and the resolution of well-founded allegations concerning serious negligence or misconduct substantially affecting the integrity of the forensic results, or noncompliance with ASCLD/LAB standards by accredited laboratories and their employees that are received from sources independent of the accreditation or self-evaluation process.
2. Receipt of Allegation
Allegations of serious negligence, misconduct or noncompliance (hereinafter referred to as the complaint) should be in writing and should identify the originator of the complaint. A complaint received by any member of the Board or the ASCLD/LAB Delegate Assembly shall be forwarded immediately to the ASCLD/LAB Executive Director, who shall log the complaint in a file created for the purpose of tracking the complaint from the date of receipt through the disposition of the matter. The complaint shall then be promptly forwarded to the Chair of ASCLD/LAB and the complainant will be notified that the complaint has been received. ASCLD/LAB may also initiate this procedure when it becomes aware, other than by a complaint, of any information suggesting serious negligence or misconduct substantially affecting the integrity of the forensic results, or noncompliance with accreditation standards, by an accredited laboratory and its employees. For purposes of this process, the term “complaint” shall hereinafter refer to both a written complaint and information received other than by a written complaint.
3. Review of Complaints
Upon receipt of a complaint, the Chair shall review it to determine whether there is a basis to believe that the conduct alleged comes within the scope of ASCLD/LAB’s accreditation jurisdiction and potentially involves serious negligence or misconduct substantially affecting the integrity of the forensic results, or noncompliance with ASCLD/LAB standards. If it is determined by the Chair that there appears to be a basis to believe that the complaint is within the purview of ASCLD/LAB and potentially involves serious negligence or misconduct substantially affecting the integrity of the forensic results, or noncompliance with ASCLD/LAB standards, the Chair shall direct the Executive Director to notify the affected laboratory that a complaint has been received and convey the substance of the complaint. When deemed appropriate by the Chair, an opportunity shall be offered for the director of the affected laboratory to provide a written response to the Chair concerning the complaint or allegation.
If the Chair determines, as a result of the preliminary inquiry, that the complaint does not fall within the purview of ASCLD/LAB, or that there is not a good faith belief that the complaint or allegations may be well founded, he or she shall issue a written report of such determination to the Board, setting forth the basic facts of the allegation and the reasons for the determination set forth in the report. The Board shall review the report and may, by majority vote, terminate further inquiry or request further inquiry. If the Board terminates the inquiry, it shall direct the Executive Director to notify the subject laboratory of the complaint and its allegations and the disposition by the Board. The Executive Director shall also notify the complainant, where possible, that the matter has been closed.
Whenever the Chair or the Board determines that the allegation comes within the scope of ASCLD/LAB’s accreditation jurisdiction and potentially involves serious negligence or misconduct that could substantially affect the integrity of the forensic results, or noncompliance with ASCLD/LAB standards, the Chair or the Board shall direct the Executive Director to appoint a Staff Inspector or another competent individual, who, unless otherwise appropriate, has experience as an inspection Team Captain and/or Lead Assessor, to conduct an investigation of the allegations made in the complaint. The person so appointed will be referred to as the Case Manager. The Case Manager may, with the approval of the Chair, enlist the assistance of members of a PRC or TAC, members of the Delegate Assembly, inspectors, or outside consultants, to aid the investigatory process. A member of the Board shall be appointed to be the liaison between the Board and the Case Manager.
The Executive Director shall also notify the accused laboratory that a preliminary inquiry has determined (1) that the alleged conduct falls within the purview of ASCLD/LAB, and (2) that further investigation is necessary to determine if there is validity to the allegations. The notice shall also include a copy of this procedure and the name of the Case Manager who will be investigating the allegations.
If a complaint or other information meeting the criteria set forth above is received between the date of the submission of an application for accreditation (including renewal of accreditation) and before the accreditation decision by the Board of Directors, the allegation(s) may be referred to the Lead Assessor assigned to the accreditation process for that laboratory. The Lead Assessor, with the aid of his or her team, will resolve, in coordination with the Board, the allegation(s) during the accreditation process, consistent with relevant parts of this document.
Investigations of complaints received from defendants in criminal cases may be deferred until final judgment, if the case to which the laboratory’s involvement pertains is pending. When a complaint is received from a prisoner, and an appeal, petition for writ of habeas corpus, or other post-conviction proceeding is pending in the matter to which the laboratory’s involvement pertains, the investigation of the complaint may be deferred until the conclusion of the legal process, if the same issue or issues have been raised in the proceeding.
4. Conflicts of Interest
The Case Manager, the members of the investigating team, if any, and the Board member liaison for the matter, shall each certify to the Chair that he or she has no conflict of interest with respect to the laboratory against which the allegations are made.
5. Appropriations for the Investigation
ASCLD/LAB shall appropriate funds to pay for the expenses of the Case Manager and his or her investigative team. Prior to the expenditure of funds by the Case Manager or the investigating team, the proposed expenditures shall be submitted to the Executive Director and the Chair of ASCLD/LAB for approval.
6. Investigation of the Complaint
The Case Manager, unless otherwise directed by the Board, shall, in conjunction with the investigative team, if any, assemble such data as is available, and such written or oral submissions as the subjects of the allegations and the originator of the complaint desire to submit to the Case Manager. The Case Manager, in conjunction with the investigating team, if any, may, with the consent of the subject laboratory and the Chair of ASCLD/LAB, visit the subject laboratory and conduct such inquiry as is appropriate.
7. Issuance of the Report of Investigation
At the conclusion of the investigation, the Case Manager shall issue a pre-decisional report to the Board detailing the factual background, setting forth findings of fact and conclusions, and making recommendations to the Board based upon those findings and conclusions.
The format of the report required by this section should be flexible and tailored to the nature of the allegation(s), and cite the ASCLD/LAB standards involved, where appropriate. Generally, the report should include: (1) an overview of the laboratory; (2) a statement of the allegations; (3) a description of the scope of the review; (4) a list of documentation and other materials reviewed; (5) the findings and bases for them; and (6) the conclusions with regard to the original allegations.
8. Board Evaluation of the Report
Upon receipt of the report from the Case Manager, the Board will review the report, make changes, if appropriate, and, if warranted, impose sanctions in accordance with the Accreditation Program. The Board may also take other action, such as returning the report to the Case Manager for further action.
If the report recommends no adverse action, the Board may determine by a majority vote of those present and voting that the evidence does not sustain the allegation and that no adverse action should be taken against the subject laboratory. The Board shall notify all parties of that determination and may issue a report.
If the report concludes that the allegations were sustained in whole or in part, and the Board agrees, it shall forward the reviewed report to the laboratory. If the laboratory disagrees with the findings, conclusions or proposed sanctions, if any, and desires to contest any or all of them, an opportunity for a formal board review pursuant to paragraph 9 below must be requested within 30 calendar days. In such case, the report shall not become final until the laboratory has been afforded a formal review.
If the laboratory accepts the findings, conclusions and proposed sanctions, or if the laboratory fails to respond within 30 calendar days, the review provided for in Section 9 shall be deemed to have been waived. In either event, the laboratory must submit to the Board its own corrective action plan within the 30 calendar days. The reviewed report and the laboratory’s proposed corrective action plan shall be placed on the Board’s agenda for a final decision, approval or disapproval of the proposed corrective action, and/or the imposition of sanctions. The laboratory shall thereafter provide the Board with a written response on the completion of the corrective action, at a mutually agreed upon time. The Board, if it agrees with the response, will issue a letter acknowledging the closure of the investigation.
9. The Formal Review Process
Upon receipt of the request for a formal review, the Board shall send the subject laboratory a notice of formal review setting forth the date and time of the review, and notifying the subject that there will be a reasonable opportunity to appear before the Board, be heard, and to confront the evidence or proposed sanctions. The Board shall also provide the director of the subject laboratory a copy of the Case Manager’s report, and a statement of the allegations to be resolved by the Board.
The subject laboratory’s Delegate Assembly member, or a laboratory employee designated by the delegate assembly member, shall have a reasonable opportunity to appear before the Board on behalf of the subject laboratory, and present evidence and a statement on behalf of the subject of the allegations. An attorney for the subject may be present during the formal review, and may consult with the subject, but may not participate in the review process.
The Board shall have the opportunity to question witnesses and the Delegate Assembly member or designee. Thereafter, the Board may ask the Case Manager to respond to the presentation by the subject laboratory, and may question the Case Manager. Finally, the subject may respond to the presentation made by the Case Manager and answer further questions by the Board. The Board may base its decision in whole or in part on the Case Manager’s report, or the report and other information received by the Board that it determines to be reliable.
The review shall be in executive session. The subject laboratory’s Delegate Assembly member or designee, the originator of the allegations, and the Case Manager and team members, and others at the discretion of the Board, may be present during the review, notwithstanding that it is held in executive session. The deliberations by the Board shall also be in executive session, but only Board members, staff, and others expressly invited by the Chair, may be in attendance.
Each Board member participating in the formal review shall certify prior to the review that he or she has no conflict of interest pertaining to the subject of the allegation or the originator of the allegation.
10. The Board Decision
At the conclusion of the formal review, or at such time thereafter as is appropriate, the Board may continue the matter from time to time for the receipt of further information or for the laboratory to propose and/or implement corrective action, dismiss the complaint with findings of fact, dismiss the complaint unconditionally, impose an authorized sanction, or a combination thereof. Any written findings of fact or adverse action imposed by the Board shall be by a two-thirds majority of the Board present and voting. If a two-thirds majority cannot be reached on any resolution, the complaint will be dismissed with no findings. The Board shall notify the subject of the complaint of its decision and the complainant that appropriate action has been taken or that the matter has been dismissed.
11. Sanctions
Sanctions that may be imposed are those set forth in the Accreditation Program.
12. Appeal to the Delegate Assembly
If the Board imposes a sanction, the director of the affected laboratory may appeal the Board’s decision to the Delegate Assembly according to the provisions of the ASCLD/LAB Accreditation Program. The filing of a notice of appeal and reasons therefore, pursuant to the provisions of the Accreditation Program, shall suspend the Board’s action until the ruling of the Delegate Assembly. Any sanction imposed by the Delegate Assembly, including an imposition of the Board’s decision, shall begin to run from the end of the annual meeting at which the Delegate Assembly voted on the matter.
13. Publication of Sanctions
The Board shall publish the sanction imposed by the Board on any laboratory 31 days or more after the date of the Board’s decision, if no notice of appeal has been received. If a notice of appeal has been received, the Board shall publish the sanctions imposed by the Delegate Assembly, if any, or by the Board, if its decision becomes final. If the Board or the Delegate Assembly dismisses the complaint, such action may be published with the consent of the laboratory.
14. Confidentiality
The Case Manager, members of the investigating team, members of the Board, and ASCLD/LAB employees, shall keep the information, evidence, findings of fact, and conclusions confidential, unless:
A. The information is required to be revealed by judicial process;
B. Disclosure is requested by the laboratory; or
C. The laboratory appeals the Board’s decision to the Delegate Assembly.
Notwithstanding the above, the Board may publish a summary of the findings of fact and the sanction, if any, imposed on the subject laboratory, as provided above.
15. Retention of Records
The evidence assembled, the recordings of any review before the Board, and any notes, memoranda, draft reports, or other papers created by the investigative team, shall be retained in compliance with the ASCLD/LAB policy on Records Retention. The Case Manager’s report to the Board shall be a draft for the Board’s consideration and is pre-decisional in nature.
16. Reimbursement for Expenses
ASCLD/LAB may recover the costs of such investigations from the laboratory if the Board concludes, based on the information available to it, that the laboratory willfully operated in noncompliance with accreditation standards, was knowingly negligent, or knowingly engaged in serious misconduct.
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