General Requirements (Accreditation Program Components)

Accreditation programs must provide consistent, objective and equitable evaluations of applicant and accredited laboratories. Program records must be maintained in a manner that ensures confidentiality of laboratory information, as well as any specimen information submitted to the program (e.g. data packages). Accreditation program components include, but are not limited to, the following:

1. Accreditation Standards

The accreditation of workplace drug-testing laboratories must be based on assessment of the laboratory’s competence and compliance with specified standards E.g., HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs CAP FUDT Accreditation Standards, ISO/IEC 17025). The standards and any supplemental documents (e.g., program guidance documents, manuals, and supplemental guides) must define the technical and administrative criteria that will be used as the basis for judging acceptable laboratory performance in the accreditation program. As noted previously, workplace drug-testing laboratories must ensure not only that their test results are scientifically valid but must also ensure their forensic defensibility. Therefore, the criteria used by the accreditation body must address both scientific and forensic requirements.

2. Laboratory Application Process

The accreditation program should have a straightforward process for applying to the program. The process should utilize an application form to be completed by the applicant and submitted, along with supporting documentation, for review by accreditation program staff. The requested information should be sufficient to document that the applicant laboratory has appropriate facilities, analytical instruments and equipment, methods, q~fi ed staff, security and standard operating procedures (SOPs) in place. Those laboratories whose applications meet defined acceptance criteria should be invited to participate in the next steps toward accreditation (e.g., proficiency testing on-site inspection). A diagram of this process is depicted in Figure 16 3.

3. Inspector Selection, Training, and Ongoing Escalation

The accreditation body should have an inspector pool of qualified forensic scientists with extensive experience in applicable aspects of forensic toxicology and in workplace drug testing. Inspectors must receive initial training and periodic refresher training that covers the accreditation program’s standards and procedures, as well as information on relevant scientific and forensic issues. The accreditation body should monitor the ongoing performance of their inspectors through various mechanisms including review of their inspection documents (Eg: completed checklists, reports) observation at on-site inspections, and feedback from laboratory staff and fellow inspectors. The program must maintain up-to-date records of each inspector’s relevant training, educational qualifications and work experience along with any information from the inspector monitoring processes.

4. Evaluation of Laboratory Director/Responsible Person

It is necessary for the workplace drug-testing laboratory to assign management and oversight responsibilities to one or more individual s with appropriate educational qualifications and extensive experience in applicable aspects of forensic toxicology and in workplace drug testing. This place may be referred to as the laboratory director or the responsible person. The accreditation body should have procedures to review and verify the educational qualifications and work experience of such individuals as part of the application process, and to conduct an on-site interview before recognizing the individual as the director/responsible person. The accreditation body should continue to assess the individual’s performance through subsequent accreditation activities (Eg: interview at each on-site inspection, ability to resolve identified problems during remediation processes). The director/responsible person must be knowledgeable of the science behind the analytical methods in use in the laboratory, understand forensic issues, know the accreditation program standards, be fully familiar with all laboratory operations related to workplace drug testing, and be involved in the daily management of the laboratory.

5. On-Site inspections

On-site inspections must be formatted to enable evaluation of the laboratory’s ongoing fulfillment with the accreditation program’s defined scientific and forensic standards, and to allow assessment of the Laboratory’s capabilities related to its facilities, analytical instruments and equipment, SOPs, and staff. The onsets inspection process is summarized in Figure 16.4.

On-site inspections should include observation and review of laboratory processes from specimen receipt to reporting; a review of the laboratory SOPs; review of the physical and operational security of the laboratory facility and individual forensic areas; staff interviews; and review of assay validation records, maintenance records for instruments and equipment, and quality control (QC) and quality assurance (QA) records, including relevant proficiency testing results. The inspectors must review other features of the laboratory’s operations (Eg: computer systems, offsite records storage areas, administrative support activities) as needed to assess the laboratory’s competence and compliance with accreditation standards. Each inspection should also include a review of the adequacy and implementation of any corrective actions taller in response to deficiencies identified doling the previous inspection. An exit interview may be held to allow the inspectors to present a sump of major findings to laboratory staff.

6. Specimen Records Audit

The accreditation body should assume periodic audits of a representative sampling of specimen records to verify the validity of analytical data, associated documents (e.g., chain of custody documents), and reports. The audit may take place during a regular on-site inspection or may be scheduled as a separate event, depending on specimen workload or of her circumstances (e.g., to review records of previously reported specimens when a serious error has been identified). It may also be possible for a laboratory to submit data packages or limited documentation to the accreditation body for a records audit. However, this type of audit may be cost-prohibitive and labor-intensive if a large number of records must be assembled and shipped.

7. Inspection Report

The accreditation body’s post-inspection processes must have purposeful criteria and ensure a thorough review of inspector submissions (e.g., completed checklist, report), to enable the consistent and equitable evaluation of laboratory performance. The accreditation body should send inspection findings to the laboratory in a timely manner, and include clear instructions for required laboratory actions.

8. Proficiency Testing Program

Each workplace drug-testing laboratory should contribute in an external proficiency testing (PT) program. Such programs verify the accuracy of the laboratory’s test results and allow the laboratory to compare their performance to that of their peers. A diagram of the inter-relations of the NLCP PT program is depicted in Figure 16.5. Acceptable PT performance supports forensic test results. Accreditation programs may include a PT program or specify acceptable PT programs for their accredited laboratories. The accreditation program should specify the frequency of PT cycles (E.g., quarterly). PT samples for workplace drug-testing laboratories should be designed to challenge the laboratories’ abilities to analyze samples contusing the drugs or drug metabolites of interest in samples that mimic donor specimens. The PT samples should include human or synthetic samples that mimic the biological matrices that the laboratory is testing. Laboratories should process the PT samples using the same procedures as for routine specimens. The program should also include negative Drug-free samples, samples containing interfering substances or cross-reacting compounds and, in the case of urine drug testing, samples that have been adulterated or diluted.

9. Error Remediation Processes

Examination findings and PT results must be communicated to the laboratory in a timely manner, with deficiencies and requirements for error remediation processes clearly described. The remediation processes for both inspection and PT should be conducted to ensure that corrective actions are taken in response to identified deficiencies, with the laboratory submitting a plan of action (POA) and report of completed actions to document implementation of acceptable corrective actions. Deficiencies may be identified through other means (e.g. information received from laboratory clients, MROs, or donors). A remediation process allows the laboratory to bring its operations into compliance with the scientific and forensic standards for accreditation. In addition, the process allows the laboratory to practice root cause analysis and ensures documentation of investigation and action. As noted previously, the adequacy and implementation of laboratory actions should be reviewed during subsequent on-site inspections. In some cases, a follow-up inspection may be required outside the regular inspection schedule.

10. Procedures for Suspension or Revocation of Accreditation

Serious deficiencies may be identified during the various accreditation activities or be reported to the accreditation body by an outside party. The accreditation program should have clearly specified the circumstances that may prompt suspension or revocation of accreditation. For workplace drug testing accreditation programs, any actions or conditions that have resulted in or may result in unwarranted adverse employment actions against a donor (Eg: false positive test results), or otherwise cause inaccurate test results or erroneous test reports, should lead to suspension or revocation of the laboratory’s accreditation. The procedures should include a means for the laboratory to reapply or become re-accredited upon demonstrating that the serious deficiency has been corrected and that it is in full compliance with accreditation program standards.

11. Appeals Processes

The accreditation body should have an appeal process to handle requests by applicant or accredited laboratories for reconsideration of any adverse decision made by the accreditation body. These adverse actions include, but are not limited to:

· Refusal to accept an application,

· Refusal to carry on with an inspection,

· Corrective action requests;

· Rejection of a director responsible person candidate;

· Decisions to contradict, suspend, or revoke accreditation;

· Any other action that affects the laboratory’s accreditation.

In all cases, the laboratory should be allowed to submit arguments and evidence to support their position. The accreditation body must have procedures for objectively evaluating the submission, reviewing, and deciding on the validity of program actions, and responder to the appellant laboratory. In cases of denied, suspended, or revoked accreditation, the appeals process should include designation of an independent parlor to review all evidence and decide on the validity of the accreditation program actions.

12. Feedback and Complaints

The accreditation body should cheer and provide a means for open communication, to allow laboratories, inspectors, and other interested parties E.g., MROs, specimen collectors donors to ask questions and to share information. There should also be a means to distribute information on workplace drug-testing issues and any new or revised accreditation program requirements to inspectors and accredited laboratories. In addition, the accreditation body should have an SOP for handling any complaints about its own processes, actions, or staff, to ensure that issues raised are reviewed for validity and handled in an impartial and expeditious manner, and to resolve identified problems. Furthermore, the accreditation body should have procedures for handling complaints about its inspectors or its accredited laboratories, including procedures for investigating and taking action in response to reported problems. These should include procedures for suspending or removing inspectors from the active inspector pool. All complaints should be recorded, all actions should be fully documented, and a final response should be sent to the complainant to close the matter.

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