Common use of Accreditation Process Clause in Contracts

Accreditation Process. Re-accreditation is an arduous task that can take up to 12 months from the submission of the applications to completion. The process begins when ISPFS submits the applications and conformance files to the selected accrediting body. The accrediting body will review the submitted documents to determine conformance with hundreds of accreditation standards, which are the current industry standard. Any deficiencies identified during the document review will be remediated before proceeding with the on-site assessment. This remediation process may take months to complete. Once the document review process is complete, the accrediting body will assemble a team of qualified assessors for the on-site assessment of all three laboratories and ISPFS headquarters adjacent to the Meridian laboratory. The team will evaluate facilities, security, conduct interviews of personnel, conduct an audit trail, witness personnel conducting laboratory work, and review numerous additional records like case files, equipment calibration logs, reagent reliability testing, etc. The accrediting body will compile the results of the assessment into a final report. All findings of non-compliance will be addressed and corrected to the satisfaction of the accrediting body prior to accreditation being awarded. The locations which comprise ISPFS include: Coeur d’Alene Laboratory ▇▇▇ ▇▇▇▇▇▇ ▇▇. Ste. B Coeur d’ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ 6 PT Positions 2 Admin ISPFS Headquarters ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇ 1 PT Position 3 Admin Meridian Laboratory ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇ 22 PT Positions 3 Admin Pocatello Laboratory ▇▇▇ ▇. ▇▇▇▇▇ Pocatello, Idaho 83201 6 PT Positions 2 Admin Collectively, the ISPFS laboratories offer service in the following areas: Drug Chemistry Controlled Substances Clandestine Laboratory Analysis Methamphetamine Quantitation Fire Debris Analysis Toxicology Human Performance Forensic Toxicology Post-Mortem Forensic Toxicology Biology/DNA Body Fluid Identification (Serology) DNA Nuclear Individual Characteristic Database Firearms/Toolmarks Firearms Toolmarks Serial Number Restoration Distance Determination Latent Prints Latent Print Comparisons Latent Print Processing Impression Evidence Latent Print Comparisons (AFIS) Alcohol Analysis Blood Alcohol Analysis Other Volatiles Analysis Controlled Substances (meth. quantitative analysis) Controlled Substances Controlled Substances Urine Toxicology (qualitative) Blood Toxicology (limited) Blood and Urine Toxicology (qualitative) Alcohol and Volatile Analysis Alcohol and Volatile Analysis Alcohol and Volatile Analysis Firearms/Toolmarks Biology (Screening, DNA, and DNA Database) Fire Debris/Arson Analysis/Ignitable Liquids Impression Evidence (latent print development, comparisons, and identification)

Accreditation Process. ReApplicant acknowledges and agrees that the Program’s accreditation process will consist of 4 phases, each of which is described below: 1.1 Phase 1 (Definition): (a) Applicant shall complete the pre-assessment questionnaire (the “Questionnaire”) provided by the Administrators and provide any other information reasonably requested by the Administrators. (b) The Parties may enter into a Statement of Work (“SOW”) that will further detail Applicant’s accreditation process. If there is an arduous task that can take up to 12 months from any conflict between such SOW and this Agreement, the submission terms of this Agreement will govern, unless the conflicting term(s) of the applications SOW explicitly override the conflicting term(s) of this Agreement. 1.2 Phase 2 (Assessment #1): Following the Administrators’ receipt of the Questionnaire and the Parties’ completion of any SOW, the Administrators will assess Applicant’s current pharmaceutical and life science product distribution services (the “Distribution Services”) against (a) the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), and (b) the PIC/S Guide to completionGood Distribution Practice for Medicinal Products (items (a) and (b) are collectively referred to as the “Specifications”). The process begins when ISPFS submits the applications Administrators will measure Applicant’s Distribution Services by conducting an off-site review of Applicant’s documentation and conformance files to the selected accrediting body. The accrediting body will review the submitted documents to determine conformance with hundreds of accreditation standards, which are the current industry standard. Any deficiencies identified during the document review will be remediated before proceeding with the an on-site assessment. This remediation process may take months to complete. Once review of Applicant’s business practices. 1.3 Phase 3 (Analyze): Following the document review process is completeAdministrators’ initial assessment of Applicant’s Distribution Services, the accrediting body Administrators will assemble prepare and provide Applicant with a team gap analysis report that details the findings of qualified assessors the evaluation conducted in Phase 2, including the components of Applicant’s Distribution Services that are not consistent with the Specifications, and provides a list of recommendations for improving Applicant’s Distribution Services such that they comply with the onSpecifications (the “Gap Analysis Report”). 1.4 Phase 4 (Assessment #2): Following Applicant’s receipt of the Gap Analysis Report, Applicant will take steps to implement the recommendations in the Gap Analysis Report. On a mutually agreed upon date, the Administrators will re-site assessment assess Applicant’s Distribution Services and prepare a second report detailing the findings of its evaluation (the “Re-Assessment Findings Report”). 1.5 Phase 5 (Control): Following the Administrators’ preparation of the Re- Assessment Findings Report and Applicant’s completion of all three laboratories tasks and/or deliverables set forth in any SOWs entered into hereunder, the Administrators may, in their sole and ISPFS headquarters adjacent absolute discretion, elect to issue Applicant an accreditation certificate (the Meridian laboratory“Certificate”). The team will evaluate facilities, security, conduct interviews of personnel, conduct an audit trail, witness personnel conducting laboratory work, and review numerous additional records like case files, equipment calibration logs, reagent reliability testing, etc. The accrediting body will compile the results Upon receipt of the assessment into a final report. All findings of non-compliance Certificate, Applicant will be addressed deemed to have completed the Program and corrected to may hold itself out as accredited under the satisfaction of the accrediting body prior to accreditation being awarded. The locations which comprise ISPFS include: Coeur d’Alene Laboratory ▇▇▇ ▇▇▇▇▇▇ ▇▇. Ste. B Coeur d’ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ 6 PT Positions 2 Admin ISPFS Headquarters ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇ 1 PT Position 3 Admin Meridian Laboratory ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇ 22 PT Positions 3 Admin Pocatello Laboratory ▇▇▇ ▇. ▇▇▇▇▇ Pocatello, Idaho 83201 6 PT Positions 2 Admin Collectively, the ISPFS laboratories offer service in the following areas: Drug Chemistry Controlled Substances Clandestine Laboratory Analysis Methamphetamine Quantitation Fire Debris Analysis Toxicology Human Performance Forensic Toxicology Post-Mortem Forensic Toxicology Biology/DNA Body Fluid Identification (Serology) DNA Nuclear Individual Characteristic Database Firearms/Toolmarks Firearms Toolmarks Serial Number Restoration Distance Determination Latent Prints Latent Print Comparisons Latent Print Processing Impression Evidence Latent Print Comparisons (AFIS) Alcohol Analysis Blood Alcohol Analysis Other Volatiles Analysis Controlled Substances (meth. quantitative analysis) Controlled Substances Controlled Substances Urine Toxicology (qualitative) Blood Toxicology (limited) Blood and Urine Toxicology (qualitative) Alcohol and Volatile Analysis Alcohol and Volatile Analysis Alcohol and Volatile Analysis Firearms/Toolmarks Biology (Screening, DNA, and DNA Database) Fire Debris/Arson Analysis/Ignitable Liquids Impression Evidence (latent print development, comparisons, and identification)Program.