The Colorado Bureau of Investigation s (CBI) Blood Alcohol Analyses Summary of Issues

Transcription

1 The Colorado Bureau of Investigation s (CBI) Blood Alcohol Analyses Summary of Issues On December 7, 2015, while the CBI was conducting standard quality checks, an unexplained variability of results in blood alcohol casework was observed by the Toxicology Program Manager. Because of this anomaly, the CBI suspended its blood alcohol testing to determine the reason for the variability. On December 14, 2015 and December 21, 2015, the Colorado Department of Public Health and Environment (CDPHE) was notified by two private laboratories, ChemaTox and the Rocky Mountain Instrumental Laboratories, regarding the variability of results in samples previously analyzed by the CBI and the lack of complete labeling on some of the blood vials received at the private laboratories. Because of the anomalies discovered in December 2015, the CDPHE began a review of a component of the CBI s toxicology program. The CDPHE s final report, which was made public on February 16, 2016, identified three specific issues that are described below. All three have been addressed by the CBI. The first issue was confined to the processing work of a single scientist, Forensic Scientist A. The Program Manager observed Forensic Scientist A and noticed there was a delay in the capping of sample vials. Because of this delay, evaporation occurred that erroneously lowered the result of the alcohol content. A review of the CBI s toxicology standard operating procedure (SOP) showed there was a lack of specificity in those SOPs as to the sequencing of the testing process. The procedure was immediately revised and all forensic scientists in the system were instructed on the corrected process. All of Forensic Scientist A s casework that had been conducted since the inception of the CBI s toxicology program on July 1, 2015, was reworked. Of the 123 cases reworked, 56 cases were affected by the process described above. It is important to note that in all of these 56 cases, the CBI initially reported lower blood alcohol content than the blood alcohol content identified when the cases were reanalyzed; as a result, no defendants were charged based on an erroneously high blood alcohol content. In order to solidify our confidence in the root cause of the anomalies, 10 of the 56 cases were outsourced to a third party laboratory as well as 78 cases from the remaining forensic scientists in the toxicology program. All results were confirmed and fell into the acceptable range of detectability. A second issue brought to the CBI s attention was that arresting officers were not always labeling the blood tube with the subject s name as required by CDPHE standards. The CBI has now included instructions in the blood alcohol collection kits to ensure law enforcement personnel place the subject s name on the blood tubes. It should be noted that all kits returned to the CBI by law enforcement included the subject s name written on the blood tube or on a form contained within the sealed packaging specific to that subject. When the CBI receives kits, personnel place barcodes on the blood tubes and track all items of evidence throughout the forensic process until the evidence is returned to the submitting agency. This process ensures the chain of custody is intact. The third issue identified was the need for the CBI to implement more specific protocols for reporting multiple test results on a single sample that varied by more than 10%. All necessary protocols have been appropriately revised to ensure specific reporting in these situations. The CBI has implemented a number of actions to prevent these types of issues in the future. Specifically, the CBI has augmented its procedures, provided additional training to scientists, and increased the number of tests verified through the CBI s Quality Assurance program. Further, the CBI

2 has reanalyzed existing cases to ensure accuracy in reporting, improved instructions for the evidence collection process, and coordinated with impacted jurisdictions, prosecutors, and the Colorado State Public Defender through updates and amended reports.

3 CDPHE Completes Review of CBI Toxicology Program (February 16, 2016 CBI Lakewood, CO) The Colorado Department of Public Health and Environment (CDPHE) completed a review of the Colorado Bureau of Investigation s (CBI s) Toxicology testing program and released its final report on February 16, The first finding in the report confirmed that blood alcohol analysis in 56 Driving Under the Influence (DUI) or Driving While Ability Impaired (DWAI) cases (representing less than 4% of all CBI s toxicology testing) showed erroneously lower blood alcohol levels for the drivers. The inaccurate results were caused by a technique used by one scientist that allowed alcohol to evaporate out of the samples during the testing process. The second finding in the report focused on the need for the CBI to implement more specific protocols for reporting multiple test results on a single sample that varied by more than 10%. The third finding in the report identified the need for more specific instructions for law enforcement on how to label evidence during the collection process. The CBI has implemented a number of actions to prevent these types of issues in the future. Specifically, the CBI has augmented its procedures, provided additional training to scientists, and increased the number of tests verified through the CBI s Quality Assurance program. Further, the CBI has reanalyzed existing cases to ensure accuracy in reporting, improved instructions for the evidence collection process, and coordinated with impacted jurisdictions, prosecutors, and the Colorado State Public Defender through updates and amended reports. The CBI remains committed to working with our public safety partners to conduct these important tests and to provide scientifically sound results, said CBI Director Michael Rankin. While we deeply regret the errors, the review process with the CDPHE has served as a valuable tool in refining our practices within the CBI Toxicology program, and we will continue to work tirelessly to strengthen the public s trust in our work. The CDPHE review was initiated in late 2015 when a private laboratory identified errors in toxicology testing in addition to similar anomalies detected through the CBI s Quality Assurance testing process during the same timeframe. -end-

4 February 10, 2016 Jeffery Groff Laboratory Certification Program Manager Colorado Department of Public Health and Environment RE: Complaint Investigation Onsite Inspection Report Dear Mr. Groff, On January 27, 2016 the Colorado Bureau Investigation Forensic Services Section (CBI-FS) received a written onsite complaint inspection report. This and accompanying documents will address the listed findings in the inspection report. Finding: B.4.a. Specimen receiving. Response: Please see document: Corrective Action Report titled Labeling of Blood Vials. Finding: B.4.o. Recording and reporting assay results. Response: Please see document: Corrective Action Report titled Reporting. Finding: B.4.s. Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by the testing analyst(s). Response: Please see document: Corrective Action Report titled Variability of Alcohol Results. The documents attached and the information provided during your onsite inspection, represents the CBI- FS s response to the CDPHE Onsite Inspection Report. Please contact us for anything additional you may require. Clinton S. Thomason Director of Quality Operations Colorado Bureau of Investigation Dan Anderson Toxicology Program Manager Colorado Bureau of Investigation Attachments: Three Corrective Actions, TOX 10-10, TOX 04, 700 Kipling Street Suite 1000, Lakewood, CO cdpsweb.state.co.us John W. Hickenlooper, Governor Stan Hilkey, Executive Director

5 John W. Hickenlooper, Governor Larry Wolk, MD, MSPH Executive Director and Chief Medical Officer Dedicated to protecting and improving the health and environment of the people of Colorado Laboratory Services Division 8100 Lowry Blvd. Denver, Colorado (303) January 27, 2016 Dan Anderson - Laboratory Director Clinton Thomason - Quality Director Colorado Bureau of Investigation 79 North Silicon Drive Pueblo West, CO RE: Complaint Investigation Onsite Inspection Report Dear Mr. Anderson, STATE OF COLORADO Colorado Department of Public Health and Environment Enclosed is the report for your on-site laboratory inspection conducted on January 14, 2016 in response to a complaint received by the Colorado Department of Public Health and Environment (CDPHE) on December 14, Policies, procedures, corrective action documentation, equipment, test data and personnel records employed in the analyses of Blood Alcohol testing were reviewed and evaluated to determine compliance with the Rules and Regulations of the Colorado Board of Health Relating to Tests for Alcohol and Other Drugs (5-CCR ). Please return a written Plan of Correction, with dates of implementation, for any deficiencies referenced in the attached inspection report. The Plan of Correction must be dated, signed by the Laboratory Director and received in this office within 15 days of receipt of this report. It may be sent either by , fax or US mail using the address below. Send to: Certification Program CDPHE/LSD 8100 Lowry Blvd Denver, CO Attn: Jeff Groff fax: If I can be of assistance, or if you have any questions, do not hesitate to contact me at or by . Thank you for your ongoing cooperation during the complaint investigation process. Jeff Groff Laboratory Certification Program Manager CDPHE/LSD jeff.groff@state.co.us

6 DUI AND DUID LABORATORY CERTIFICATION ONSITE EVALUATION REPORT TO DETERMINE COMPLIANCE WITH THE STATE BOARD OF HEALTH RULES PERTAINING TO TESTING FOR ALCOHOL AND OTHER DRUGS (5 CCR ) COLORADO BUREAU OF INVESTIGATION (CBI) TOXICOLOGY LABORATORY 79 SILICON DRIVE PUEBLO WEST, CO ONSITE COMPLAINT INSPECTION PERFORMED JANUARY 14, 2016 BY JEFF GROFF DUI-DUID LABORATORY CERTIFICATION PROGRAM COLORADO DEPARTMENT OF PUBLIC HEALTH & ENVIRONMENT LABORATORY SERVICES DIVISION 8100 E. LOWRY BOULEVARD DENVER, COLORADO Page 1 of 4 1

7 Name: CBI Pueblo Laboratory 79 Silicon Drive Pueblo West, CO Date: January 27, 2016 Introduction An onsite inspection was conducted by Department staff at the Colorado Bureau of Investigation (CBI) Pueblo laboratory on January 14, 2016 as part of the complaint investigation process. Evaluation of personnel training records, equipment, standard operating procedures and corrective action documentation related to the collection, labeling and analyses of DUI-DUID Blood Alcohol samples was performed in order to verify compliance with the provisions in the Colorado Board of Health Rules Pertaining to Testing of Alcohol and Other Drugs (5 CCR ). Complaint Summary The Department was notified by two separate complainants on December 14, 2015 and again on December 21, 2015 regarding the labeling of blood alcohol specimens and blood alcohol test results reported by the Colorado Bureau of Investigation (CBI) Toxicology Laboratory. On December 31, 2015, CBI reported to the Department that they had identified discrepancies with some of their blood alcohol test results and that an internal root cause analysis and investigation had been initiated. A formal complaint investigation was initiated by the Department to determine if the allegations of the complainants were either substantiated or unsubstantiated. Initial interviews of the complainant(s) were conducted and requests for additional documentation were made by the Department as part of the investigation process. Upon completion of the complainant interviews and receipt of the requested supporting documentation, an onsite inspection was then performed. The onsite inspection was conducted at the CBI-Pueblo laboratory by Department staff on January 14, The onsite inspection included, but was not limited to, the review of personnel training records, equipment records, testing data, corrective action documentation and staff interview for the purposes of investigating the allegations received by the Department and to verify compliance with the certification requirements for forensic toxicology laboratories found in the Colorado Board of Health Rule (5CCR ). This inspection report includes the findings resulting from the complaint investigation. Inspection Findings B. Standard Operating Procedure Manual 4.) Does the Standard Operating Procedure (SOP) manual include the following criteria and processes for laboratory personnel to follow? a.) Specimen receiving Based on review of Standard Operating Procedures, Specimen Labels, Forensic Collection Kits and Lab Director Interview, the laboratory failed to follow the Tox 4: Handling of Toxicology Evidence procedure to ensure that the specimen labeling instructions provided in the CBI forensic blood specimen collection kits are consistent with the established policy. Findings Include: 2

8 a. The Tox 4: Handling of Toxicology Evidence procedure states that at minimum, samples must be labeled with an agency case number or unique identifier and the subject s first and last name. b. Samples collected using the CBI forensic toxicology collection kit do not include labeling instructions that specify that this information be included on the blood tubes themselves. c. Samples are received in a sealed CBI forensic toxicology collection kit and do contain the required case number and subject s first and last name. However, this information is provided on separate forms included in the CBI forensic collection kit, but is not found on the samples themselves. d. Review of the chain of custody records revealed that discrepancies in labeling are documented and recorded by CBI upon receipt and accessioning. e. Samples sent out for secondary testing to another certified forensic toxicology laboratory have a CBI accessioning label affixed to the sample in the form of a unique identifying laboratory number that also contains a bar code in addition to a specimen security seal containing the law enforcement officer s initials and date. f. The Lab Director confirmed that the specimen labeling instructions provided in the CBI forensic collection kits are not consistent with the labeling procedures found in Tox 4: handling of Toxicology Evidence procedure. o.) Recording and reporting assay results? Based on review of Standard Operating Procedures, Test Reports, Analytical Data and Lab Director interview, the laboratory failed to include criteria for accepting or rejecting analytical data when repeat duplicates differ greater than 10% between analytical runs prior to reporting results for one case reported on September 14, Findings Include: a. One blood alcohol test reported on September 14, 2015 provided a result of present greater than g/100ml. b. The reported result contained the following notation; *Ethanol analysis performed multiple times. Although all quality control measures were acceptable, analytical results for ethanol were not consistent with each other and precision could not be obtained. The determined ethanol concentrations ranged from to g/100ml. c. Review of test data revealed that the sample had been tested by different analysts on different days that resulted in variations in the reported results greater than 10% from run-to-run. d. Review of test data revealed that the sample quality control measures met the established acceptability criteria in each analytical run each day of analysis. e. The Lab Director stated that the decision was made to include all the results from each analytical run in the form of a range for this case on the final report. f. The Lab Director confirmed that the TOX 10-10: Ethanol Analysis by Headspace Gas Chromatography (HS/GC-FID) procedure in use at the time of the analysis did not include instruction for reporting results in the form of a range when variations from analytical run-to-run exceeded 10%. s.) Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by the testing analyst(s). Based on review of Standard Operation Procedures, Test Reports, Analytical Data, Experimental Data, Personnel Training Records, Equipment Records, Corrective Action Reports and Lab Director Interview, the laboratory failed to include sufficient step-by-step detail in the TOX 10-10: Ethanol Analysis by Headspace Gas Chromatography (HS/GC-FID) standard operating procedure used by testing analyst(s) performing blood alcohol testing to ensure the sequence of sample pipetting and headspace vial capping instructions are clearly specified to prevent evaporation of ethanol from the sample. Findings Include: a. As part of a quality assurance review, on December 7, 2015, it was discovered that the results of one analyst performing blood alcohol testing were consistently lower than that of the other analysts. b. Further investigation revealed that the analyst s analytical run and sampling set-up technique 3

9 varied from the other analysts resulting in evaporation of the alcohol contained in the sample prior to analysis. c. The standard operating procedure in use failed include specific instructions for the order of pipetting and capping of the headspace vials during the analytical run and sampling set-up. d. A total of 56 samples among 5 different batches were impacted with erroneously low results reported since July 1, e. The Lab Director confirmed that the TOX 10-10: Ethanol Analysis by Headspace Gas Chromatography (HS/GC-FID) standard operating procedure used by testing analyst(s) failed to include sufficient step-by-step detail to prevent evaporation of sample ethanol during the set-up of the analytical run. PLAN OF CORRECTION The plan of correction must include, but is not limited to, the corrective actions taken by the laboratory to identify all potentially impacted test results, the corrective actions taken by the laboratory correct the identified problems and the quality assurance measures put into place by the laboratory to prevent the deficiencies from re-occurring in the future. In addition, the plan of correction must include who will be responsible for monitoring the corrective actions taken and how these corrective actions will be monitored on an ongoing basis. Certification of the CBI-Pueblo Toxicology Laboratory will remain effective from September 4, 2015 through June 30, 2016 pending an acceptable plan of correction is provided with applicable supporting documentation to the Department s Certification Program within 15 days of receipt of this report. 4

10 COLORADO Department of Public Health & Environment Dedicated to protecting and improving the health and environment of the people of Colorado February 11, 2016 Dan Anderson - Laboratory Director Clinton Thomason - Quality Director Colorado Bureau of Investigation 79 North Silicon Drive Pueblo West, CO RE: Complaint Investigation Plan of Correction Dear Mr. Anderson and Mr. Thomason, The Department is in receipt of your Plan of Correction (POC) in response to an on-site laboratory inspection conducted on December 14, Upon review of the POC and supporting documentation, the Department finds the corrective actions taken by CBI to be credible and acceptable. Certification remains effective through June 30, 2016, unless modified prior to that date, and is based upon the acceptable POC submitted February 10, 2016, and your laboratory's successful participation in Proficiency Testing studies for Blood Alcohol and Urine I Blood Drugs. Thank you for your cooperation during the onsite complaint inspection process. If you have any questions, or if there are changes that may affect your certification status, please contact me at (303) or by . Sincerely, Jeff Groff Laboratory Certification Program Manager CDPHE/LSD jeff.g roff@state.co. us Laboratory Services Division 8100 Lowry Blvd., Denver, CO P John w. Hickenlooper, Governor 1 Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer

11 Jeffery Groff Laboratory Certification Program Manager Colorado Department of Public Health and Environment Via Electronically Variability of Alcohol Results - Corrective Action CDPHE inspection report finding B.4.s Problem Statement: On it was determined that alcohol testing results varied between analysts who conducted the tests. Immediate Action Taken: Conducted analysis on same ten cases by six scientists. Determined an issue existed with one scientist s results. One scientist removed from casework. Evaporation experiment completed leading to the root cause. Notified the toxicology scientists to immediately cap all vials after sampling. Notified the Colorado Department of Public Health and Environment. Root Cause: Scientist s sampling process where 100 ul of blood sample was being sampled into a head space vial (without internal standard solution) and not capped quickly enough causing evaporation of the volatile substance. Existing procedures did not specify sampling instructions in a manner that would have prevented the root cause. Corrective Action: 1. Identify the 123 positive alcohol cases completed by the one scientist Time to complete: Completed December Reanalyze 123 cases from the scientist resulting in 56 affected cases outside the 10% range of the original reported results. Responsible: Toxicology Staff Time to complete: Completed January Notify the agencies affected by the 56 cases. Responsible: Executive Staff Time to complete: Completed

12 4. Send 10 samples from the 56 affected cases to an outside laboratory for verification of the amended results. Time to complete: Completed - All results were acceptable 5. Issue amended reports for the 56 cases. Responsible: Toxicology Staff Time to complete: Completed January Revise TOX to specify sampling instructions to include capping times to prevent evaporation. Time to complete: Completed January Toxicology scientists trained on revised TOX procedure. Time to complete: Completed January Issue quality reports to customers for the remaining 67 cases that were not affected notifying them their cases were not affected. Responsible: Toxicology Staff Time to complete: February, Send an additional 78 samples from the remaining toxicology scientists casework from the beginning of the toxicology program to an outside laboratory for verification. Time to complete: Completed February 2016 All results were acceptable. 10. Courtroom testimony training for toxicology scientists. Time to complete: Completed February, Literature search to review the volatility of ethanol within a sample. Time to complete: March, 2016 Monitoring: 1. Two samples from two alcohol batches per scientist sent to outside lab for reanalysis /Toxicology Staff Time to complete: April Two samples from each alcohol batch per scientist reanalyzed by another scientist internally /Toxicology Staff Time to complete: July 2016

13 Jeffery Groff Laboratory Certification Program Manager Colorado Department of Public Health and Environment Via Electronically Reporting - Corrective Action CDPHE inspection report finding B.4.o Problem Statement: CDPHE B.4.o requirements state Does the laboratory have established criteria of acceptability not to exceed 10% for variances between the results of the blood ethanol analysis using different aliquots and between different columns. An ethanol range was reported for a single case because of variance (greater than 10%) in analysis. Immediate Action Taken: Notified toxicology scientists not to report a range. Root Cause: TOX 10-10: Ethanol Analysis by Headspace Gas Chromatography (HS/GC-FID) had specific language stating the results had to be within 10%, however did not have specific language in the Quality Control and Acceptance Criteria for subsequent results that may not be within 10% between analytical batches. Corrective Action: 1. Revise TOX to provide procedures for reporting ethanol results that are greater than 10% between analytical batches Time to complete: Completed 2. Train toxicology staff on new procedure Time to complete: Completed 3. Train administrative review staff on new procedure. Time to complete: Completed 700 Kipling Street Suite 1000, Lakewood, CO cdpsweb.state.co.us John W. Hickenlooper, Governor Stan Hilkey, Executive Director

14 Monitoring: 1. While conducting batch reviews, technical reviews (TRV), and writing reports, reviewers will ensure the reported casework conforms with TOX / Toxicology Staff Time to complete: Continuous 700 Kipling Street Suite 1000, Lakewood, CO cdpsweb.state.co.us John W. Hickenlooper, Governor Stan Hilkey, Executive Director

15 Jeffery Groff Program Manager Colorado Department of Public Health and Environment Via Electronically Labeling of Blood Vials - Corrective Action CDPHE inspection report finding B.4.a Problem Statement: Submitting Law Enforcement agencies are not labeling 100% of the blood vials with a unique identifier, the subjects name or the Agency s case number. Immediate Action Taken: reminders to all agencies to provide unique identification information on the blood vials (July 2015) CBI Evidence Technicians to place a reminder footnote on all Evidence receipts to appropriate label each blood vial (July 2015) Modification of the Colorado State Patrol form to include labeling subjects name on blood vials (September 2015) Advise Toxicology Staff to transfer subject s name or Agency Case number from secondary container or Laboratory Examination request form to blood vials (December 2015) Complete documentation of blood vial labeling by lab staff in Laboratory Information Manager (LIMS) as the vial is found upon receipt and any alterations by lab staff (December 2016) Root Cause Blood Collection Kit as purchased from vendor did not provide specific instructions on the Collection Instructions to label the blood vials. Corrective Action: 1. Placed two small blood vial labels, Subjects Name:, in each blood collection kit (December 2015). Responsible: CBI Staff Time to complete: As kits are issued 2. Place one small label on the top and one large label (red font) on the front of the blood collection kit that states: Please label tubes with subjects name (December 2015). 700 Kipling Street Suite 1000, Lakewood, CO cdpsweb.state.co.us John W. Hickenlooper, Governor Stan Hilkey, Executive Director

16 Responsible: CBI Staff Time to complete: As kits are issued 3. Revise language in Tox-04: Handling of Toxicology Evidence to include specific procedures for documentation in LIMS and labeling of tubes. Time to complete: Completed February Revise collection instructions with the vendor of the toxicology kits before the next order. Responsible: Forensic Management Time to complete: Before the next order Monitoring: 1. Toxicology staff will monitor Law Enforcement s blood vial labeling. /Toxicology Staff Time to complete: Ongoing 700 Kipling Street Suite 1000, Lakewood, CO cdpsweb.state.co.us John W. Hickenlooper, Governor Stan Hilkey, Executive Director