Quality Assurance and Accreditation in the Laboratory Summary Bill Phillips, California DOJ Introduction and your interests Those attending this roundtable were from public and private laboratories and those from public labs represented city, county and state labs. There were owners of their own private labs as well as those who worked for private labs. Reason for choosing to be accredited. Does your quality assurance program meet the standards of the forensic science community? Accreditation may assist you in assessing your needs Forensic Laboratory Accrediting Agency American Society of Crime Laboratory Directors / Laboratory Accreditation Board (ASCLD/LAB) o ASCLD International http://www.ascld-lab.org/international/indexinternational.html o The list of Laboratories accredited by the ASCLD/LAB International program was not available at the website. This accreditation process incorporates the ISO Standards (ISO/IEC 17025:1999). o ASCLD Legacy http://www.ascld-lab.org/legacy/indexlegacy.html o 283 crime laboratories have been accredited by ASCLD/LAB under the Legacy Program as of January 26, 2005. The list of accredited laboratories includes 170 state laboratories, 70 local agency laboratories, 21 federal laboratories, 9 international laboratories and 13 private laboratories. o The ASCLD/LAB Legacy program will continue to receive applications for renewal and new applications for a period of five years from April 01, 2004, and will continue to support the Legacy program another five years until all accreditations have expired. During this period, laboratories have the option of applying for accreditation under the existing program or under the standards of the ISO 17025 program. At the end of the period the international program with the ISO 17025 standards will become the only option. The ASCLD/LAB application fee structure for new applicant laboratories and laboratory systems is as follows: Five hundred dollars ($500 US) for laboratories having ten (10) or less proficiency tested personnel (including vacancies), at the time of the application. One thousand dollars ($1000 US) for laboratories having more than ten (10) but no more than twenty-five (25) proficiency tested personnel (including vacancies), at the time of the application. Two thousand dollars ($2000 US) for laboratories having greater than twenty-five (25) proficiency tested personnel (including vacancies), at the time of the application. Laboratory Systems will not be assessed fees greater than three thousand dollars ($3000 US), once this amount has been reached, no matter the number of laboratories or proficiency tested personnel (including vacancies). Questions regarding the application fees should be directed to ASCLD/LAB at (919) 773-2600. National Forensic Science Technology Center (NFSTC) http://www.nfstc.org/index.htm The NFSTC 2003 annual report, which describes their audit activities can be seen at http://www.nfstc.org/annual%20report.htm Other Accrediting Standards and Associations The International Association for Standardization (ISO) and the International Electrotechnical Commission (IEC) o ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories The International Laboratory Accreditation Cooperation (ILAC) http://www.ilac.org An international cooperation of laboratory and inspection accreditation bodies American Board of Forensic Toxicology (ABFT) http://www.abft.org/LabAccreditation.asp There are sixteen Labs currently accredited by ABFT Fees. The completed application package should be sent to the Chair of the ABFT Accreditation committee at the address given in the application instructions, together with the application fee of $500, none of which is refundable. Only laboratories that feel they meet the stated requirements for Accreditation should submit applications. The onsite inspection fee is a flat rate of $3000. Application forms and instructions for their submission can be obtained from: The American Board of Forensic Toxicology, Inc. Attn: The Forensic Sciences Foundation, Inc. P.O. Box 669 (410 North 21st Street, Suite 203) Colorado Springs, Colorado 80901-0669 Phone: (719) 636-1100 Fax: (719)-636-1993 E-Mail: Membship@aafs.org Clinical Laboratories Accreditation Programs The Collage of American Pathologists (CAP) http://www.cap.org/apps/docs/laboratory_accreditation/lap_info/appaccred.html o Two clinical participants mentioned CLIA and the national standards that are applied at their laboratories. Proficiency Testing ASCLD/LAB Providers http://www.ascld-lab.org/legacy/aslablegacyapprovedproviders.html ASCLD Proficiency Review Program and Proficiency Review Committee (PRC) Association dedicated to Quality Assurance The Association of Forensic Quality Assurance Managers (AFQAM) promotes standardized practices and professionalism in quality assurance management for the forensic community. ASCLD/LAB Application Process from website Crime Laboratory directors seeking information about the ASCLD/LAB Legacy laboratory accreditation should direct their inquiries to the Executive Director of ASCLD/LAB. The reply to such inquiries will be a copy of the Accreditation Manual. The process need not go any further; there is no obligation on the part of the crime laboratory director. He/she may elect to evaluate his/her own laboratory for the purpose of self-improvement without seeking accreditation. This is done without incurring obligation or expense beyond the cost of the manual. When the crime laboratory director determines that the laboratory is prepared, he/she may elect to apply formally for accreditation following the instructions in the manual. The process may continue as follows: 1. Self-evaluation by applicant laboratory 2. Application and supporting documents filed by applicant laboratory 3. On-site inspection by a team of trained inspectors 4. Inspection report considered by ASCLD/Laboratory Accreditation Board 5. One year to remedy deficiencies before final decision by the Board 6. Accreditation review completed by the laboratory annually 7. Full re-inspection required every five years. ASCLD/LAB – The following are Standards and criteria considered during the inspection process . A complete list of the criteria can be obtained by ordering the manual http://www.ascld-lab.org/legacy/aslablegacymanual.html License with Electronic Version of 2003 Manual on a CD (Adobe Acrobat format only) $ 50.00 each 1. Laboratory Management and Operations 2. Personnel Qualifications 3. Physical Plant Examples of findings during an ASCLD/LAB inspection were discussed. Evidence chain of Custody Physical plant, Safety issues. It was pointed out that most of the criteria for physical plant are import or desirable, except for the security issues, which are essential. Personnel qualifications include the requirement of a bachelor’s degree in all disciplines except of Questioned Documents and Latent Prints. The following laboratories that are currently accredited in California by ASCLD/LAB Alameda County Sheriff's Office Criminalistics Laboratory, San Leandro, CA Bureau of Alcohol, Tobacco & Firearms, Walnut Creek, CA California Department of Justice, Bureau of Forensic Services Laboratory System Contra Costa County Office of the Sheriff, Forensic Services Division, Martinez, CA Drug Enforcement Administration, Southwest Laboratory, National City, CA Drug Enforcement Administration, Western Laboratory, San Francisco, CA El Cajon Police Department Forensic Laboratory, El Cajon, CA Forensic Science Laboratory, Department of Coroner, County of Los Angeles, Los Angeles, CA Los Angeles Police Department Scientific Investigation Division, Los Angeles, CA Los Angeles County Sheriff's Office, Los Angeles, CA Long Beach Police Department Crime Laboratory, Long Beach, CA Naval Criminal Investigative Service Laboratory, San Diego, CA Oakland Police Department, Oakland, CA Orange County Sheriff- Coroner Department, Santa Ana, CA Sacramento County District Attorney's Laboratory of Forensic Services, Sacramento, CA San Bernardino County Sheriff's Office, San Bernardino, CA San Diego Police Department Crime Laboratory, San Diego, CA San Diego Sheriff's Department Regional Crime Laboratory, San Diego, CA Santa Clara County District Attorney's Crime Laboratory, San Jose, CA San Francisco Police Department Criminalistics Laboratory, San Francisco, CA Serological Research Institute, Richmond, CA Ventura County Sheriff Department Forensic Science Laboratory, Ventura, CA The following laboratories from other states are currently accredited by ASCLD/LAB and had representatives that attended the panel discussion: Arizona Department of Public Safety, Southern Regional Laboratory, Tucson, AZ Mesa Police Department Crime Laboratory, Mesa, AZ Phoenix Police Department, Laboratory Services Bureau, Phoenix, AZ Persons that attended the panel discussion from the following laboratory were accredited by the American Board of Forensic Toxicology (ABFT): New Mexico Department of Health, Scientific Laboratory Division, Toxicology Bureau Albuquerque, NM Other public and private laboratories that attended the panel discussion were licensed by the California Department of Health service to do Alcohol testing.