It is important for the accreditation body to develop and implement appropriate tools to accomplish the activities described above. These tools may include the following:
1. Application Form
A clear and brief application form is essential to ensure that applicant laboratories submit sufficient information to document their ability to meet minimum program requirements. The application process can save time and money by providing a formal means for the laboratory to assess its readiness to pursue accreditation. The application form should address program requirements in an itemized manner, thereby requiring the laboratory to perform a self-assessment versus program requirements to complete the application form, and require submission of supporting documents (E.g., key staff resumes and official university transcripts, example chain-of custody forms).
2. Application Report
The laboratory can also profit from feedback provided from the accreditation body based on review of the application. The report should detail issues raised due the application renew and request correction or clarification as needed. The laboratory’s correction and/or clarification of its procedures should facilitate the subsequent inspection process.
3. Pre-Inspection Materials
Standardized forms and documents should be implemented for submission of laboratory information before each inspection. The use of standardized forms and documents simplifies the process and, in addition, provides a means for the accreditation body to gather information on procedures, methods, and materials used by the accredited laboratory population. The accreditation body can then distribute the pre inspection materials to inspectors, providing them with information about the procedures, analytical methods, staffing, data format, and reports of the laboratory that they will inspect. In addition, the accreditation body should provide inspection instructions and updated program guidance, along with copies of the laboratory’s accreditation records (e.g., the inspection report and any remedial correspondence from the previous inspection, recent PT reports and any PT remedial correspondence), allowing sufficient time for the inspector’s renew before the event.
4. Specimen Audit List
For records audits, the accreditation body may obtain a list of reported specimens from the laboratory for audit sampling purposes. This process allows the accreditation body to select the actual specimen records to be reviewed, rather than simply specifying a number, percentage, or dates of reported specimens. The process must be scheduled to give the laboratory time to assemble the selected records for review. Furthermore, the laboratory must assemble records in a manner to facilitate review, to enable auditors to perform a thorough review of the selected records during the audit time period. The accreditation program for federal workplace drug-testing programs, the NLCP, focuses its records audits on reported “non-negative specimens i.e., specimens reported as drug-positive, adulterated, substituted, invalid, or rejected for testing. Each accredited laboratory submits a report listing all non-negative specimens reported for a specified time period. From this list, NLCP staff selects a sampling of specimens for the audit. The program has concentrated its efforts on reviewing non-negative specimens because these results may result in adverse action against an employee. “Rejected for testing” specimens also provide useful information about specimen collection and laboratory receipt. Auditors review negative specimen records in addition to non-negative specimens, as they review initial test batches containing both negative and non-negative specimens. The NLCP process has resulted in increased scrutiny of the forensic product and enhanced HHS oversight of federal workplace drug-testing programs.
5. Inspection Checklists
Accreditation bodies often develop standardized checklists, based on accreditation program requirements, for inspector use during on-site inspections. Checklists can aid the inspector in focusing on and accomplishing all the inspection tasks. The checklist completed by the inspector can be used to communicate inspection findings to the accreditation body. The NLCP uses multiple checklists, depending on the type of inspection and the assigned inspector duties. For example, the NLCP uses an Initial Laboratory Checklist for the initial onsite inspection of applicant laboratories. For each accreditation maintenance inspection, the NLCP uses 2 checklists. A General Laboratory Procedures Checklist is used by the inspectors assigned to assess the laboratory in the areas of chain of custody; specimen accessioning; security; QC materials and reagents; QA procedures and documentation; equipment and maintenance procedures and documentation, specimen validity testing (i.e., testing to identify invalid, adulterated, or substituted specimens); initial drug tests procedures, methods, and practice; confirmatory drug tests procedures, methods, and practice; result certification and reporting; SOP manual; personnel; laboratory computer systems; and verification and assessment of the laboratory’s corrective actions in response to the previous inspection. A Records Audit Checklist is used by the Inspectors assigned to perform the records audit, including review of specimen records, records of method validation and periodic re-verification, NLCP PT records and reports.
6. Inspection Report
The accreditation body should send inspection findings to the laboratory in the form of a clear and concise report that explains each issue raised, provides specific examples, and links each item to the relevant program requirement. Issues may be divided into deficiencies requiring immediate action E.g., when the accuracy or forensic acceptability of donor specimen results or reports may be affected and those less serious concerns that are brought to the laboratory’s attention for corrective action. The inspection report should provide clear instructions for required laboratory actions (e.g., submission of an action plan, records audit to identify affected specimens).
7. PT Report
Each PI cycle should be graded and results sent to the laboratory in a timely manner. The PT provider should dearly define the PT grading criteria Results should be issued in a report that provides the laboratory’s scores for that cycle and its cumulative PT scores (E.g., for 2 consecutive cycles). Each PT error should be clearly described, linked to the PT grading criteria, and the report should provide clear instructions for required laboratory actions (Eg: submission of an action plan, records audit to identify affected specimens).
a. Program Guidance
It is common for accreditation bodies or other entities (e.g., technical working group, national or international cooperative) to provide additional guidance on and interpretation of accreditation program standards in the form of a manual, guide, or document. The accreditation program should also have a means to issue information to keep its accredited laboratories and inspectors updated on program issues and new or revised requirements on an as-needed basis. The accreditation body should support and instruct its inspectors and laboratories, ensuring that qualified staffs are available to answer questions or give guidance on laboratory issues.
Table 16.2 lists some of the major components/tools that are used by the NLCP, by the CAP FUDT program for workplace drug-testing laboratories, by the DoD for military drug-testing laboratories, and that may be used by accreditation bodies accrediting laboratories to ISO/IEC 17025.
Table 16.2 is given below: