Background and Overview

Toxicology is the analysis of substances (drugs, alcohol and chemicals) found in biological samples, extracted from living and deceased individuals. Forensic toxicology is distinguished in that the reasons for conducting the analyses and/or the outcome of those analyses could potentially have some bearing on legal or judicial matters. The San Francisco Medical Examiner"s Office has been accredited by the National Association of Medical Examiners since 1974. Since the Toxicology Laboratory is part of the facility, the accreditation extends to the laboratory. The San Francisco Medical Examiner"s Office provides comprehensive forensic toxicology services that assist in determining, or provide verification of, the cause and manner of death for cases under the Medical Examiner"s jurisdiction. The Medical Examiner"s Office toxicology laboratory also provides support services for the San Francisco Police Department by: 1) analyzing alcohol and other drug and chemical substances in biological fluids seized from motor vehicle drivers under the DUI program; 2) analyzing biological fluids seized from suspects arrested for possession or under the influence of drugs under the 11550 program; and 3) analyzing specimen collected from recruits of the Police and Fire Departments.

Organizationally, the Toxicology Laboratory is part of the Medical Services Program of the Medical Examiner. The Fiscal Year 1996-97 approved budget for Medical Services is $1,485,920. Of the total approved budget for Medical Services, the Budget Analyst estimates that $497,041 is allocated for Toxicology. This level of funding ($497,041) includes salaries and fringe benefits for 5.5 FTEs which include: 1.0 FTE Forensic Lab Technician; 3.0 FTEs Assistant Forensic Toxicologist Is; 1.0 FTE Assistant Forensic Toxicologist II; 0.5 FTEs Forensic Laboratory Manager. Also included in the funding is $7,053 in temporary salaries and $42,041 in various non-personnel costs (see Section IV: Budget and Section VI Organization and Staffing for detailed information on staffing and budget).

The Assistant Forensic Toxicologist II position was created during 1988 and modified to assume additional supervisory responsibilities in Fiscal Year 1993-94. These changes were made to provide a lower-level non-management position that can supervise some of the functions in the Toxicology Laboratory. The creation of this position was in response to the elimination of the Forensic Toxicologist position as part of the Fiscal Year 1993-94 budget process.

Guidelines for Accreditation of Forensic Toxicology Laboratories

The National Association of Medical Examiner"s (NAME), the Society of Forensic Toxicologists and the American Academy of Forensic Sciences have established and recognized guidelines for the accreditation of forensic toxicology laboratories. Each of these professional organizations has established that an accredited forensic toxicology laboratory is to be directed by a Forensic Toxicologist, who meets certain educational and experience requirements The Forensic Toxicologist is to:

• Provide overall management of the laboratory;

• Supervise laboratory staff;

• Validate new drug assays; and

• Maintain a quality assurance program.

In addition, the American Board of Forensic Toxicology, Inc., Laboratory Accreditation Manual contains standards for management and administration, personnel, standard operating procedure manuals, security and chain of custody of specimen, quality assurance and quality control, analytical procedures such as immunoassays and Chromatography/Spectrometry protocols and calibrations, data review and safety. These standards and guidelines are appropriate for:

The San Francisco Medical Examiner"s Office engages in all three of these defined areas of toxicology. As such, the guidelines should be applied to the toxicological testing conducted in the Medical Examiner"s Office Toxicology Laboratory in order to ensure the integrity and quality of the results.

The specific guidelines set standards and conditions for: operating procedures which include, personnel, samples and receiving, and security and chain of custody; analytical procedures which include review of data, and quality assurance; reporting of results; and safety. Our analysis of documents from the Medical Examiner"s Office, interviews with staff and observations of procedures revealed that the Medical Examiner"s Office in not in compliance with these SFT/AAFS guidelines.

Elimination of the Forensic Toxicologist Position in the San Francisco Medical Examiner"s Office

The SFT/AAFS guidelines for toxicology laboratory personnel state:

At this time, the San Francisco Medical Examiner"s Office is not staffed with a Forensic Toxicologist. This position was eliminated during the Fiscal Year 1993-94 budget process, on the initiative of the Medical Examiner"s Office, and later replaced with an Assistant Forensic Toxicologist II position. The management and supervisory duties were assumed by the Chief Medical Examiner. The Chief Medical Examiner appears to be qualified under the SFT/AAFS guidelines to manage the laboratory. However, the Budget Analyst does not believe that, given his other duties, the Chief Medical Examiner has sufficient time to provide the level of supervision and oversight specified in these guidelines. The technical duties, previously performed by the Forensic Toxicologist, are carried out by the Assistant Forensic Toxicologist II. These duties include:

• Conducting the more complex toxicological studies for forensically significant drugs on blood, urine, and other physiological specimens from both decedents and individuals suspected of violating the law;

• Using gas and thin-layer chromatography, ultraviolet, and visible and fluorescent spectrophometry;

• Conducting various toxicological procedures as needed; and

• Operating a quality assurance program which evaluates data and ensures the accuracy of the work produced and technical proficiency of the laboratory.

Due to the elimination of the Forensic Toxicologist position during the 193-94 budget process, the direct management of the toxicology laboratory has been assumed by the Chief Medical Examiner. As previously noted, the Chief Medical Examiner does appear to be qualified to manage the laboratory based on the SFT/AAFS guidelines. However, based on the Budget Analyst"s observations and staff interviews, it is estimated that the Chief Medical Examiner spends less than five hours per week in the laboratory. After the release of the draft report, toxicology staff submitted letters indicating that the Chief Medical Examiner may spend as much as 20 hours per week in the laboratory. In a letter dated March 27, 1997, the Assistant Toxicologist II states:

Despite this statement, the Budget Analyst still believes that the time spent in the laboratory on nights and weekends and early morning hours does not provide the supervision and oversight required to ensure the quality of work performed by the laboratory staff. The estimated time the Chief Medical Examiner spends in the laboratory during business hours is not sufficient to provide the level of supervisory and administrative oversight required to: 1) ensure that the laboratory personnel are adequately trained and experienced enough to conduct the required work; and 2) ensure that the work performed is accurate, thereby monitoring the competency of the staff, including the Assistant Forensic Toxicologist II, and verifying their skill level. Additionally, the protocol for reviewing test data results, chain of custody protocols, and quality assurance could be improved.

The development of standards, operations manuals, protocols, staff training and evaluation, and quality assurance is the responsibility of the Forensic Toxicologist. These problems are exacerbated by staff from Pathology and Toxicology believing that there is a lack of leadership and supervision in the Toxicology Laboratory. As such, the Budget Analyst has concluded that the continued absence of a strong management and supervisory presence in the San Francisco Medical Examiner"s Office Toxicology Laboratory, is attributable to eliminating this position.

Disproportionate Testing of Toxicology Cases

Immediately upon the elimination of the Forensic Toxicologist position the annual case load for the Toxicology Laboratory dropped by 3,969. This reduction was primarily the result of the elimination of all Adult Probation drug testing in Fiscal Year 1993-94. The current supervisor in Adult Probation, who is responsible for most of the drug testing, reports that as a result of eliminating the Forensic Toxicologist position, the Medical Examiner"s Office no longer has sufficient staffing to perform the urinalysis for Adult Probation. Consequently, all Adult Probation urine samples are analyzed by a private laboratory at a cost of $5.00 per sample. Adult Probation also stated that this is approximately $2.00 more per sample than the Medical Examiner charged. With an average annual caseload of 3,500 this represents an additional $7,000 in costs for Adult Probation drug testing. In addition to the elimination of Adult Probation drug testing, the Fiscal Year 1993-94 Quarterly Reports, prepared by the Medical Examiner indicate that there were 178 fewer Medical Examiner"s cases requiring some level of toxicological testing .

Despite the reduction of 3,969 cases, from Fiscal Year 1992-93 to Fiscal Year 1993-94, which represents a 58.8 percent reduction, the average number of tests per case began to increase in FY 1993-94. Records maintained by the Medical Examiner"s Office show that the Toxicology Laboratory began conducting more tests, proportionately, than it had conducted under the supervision of a Forensic Toxicologist. The divergence between the number of toxicology cases and the number of toxicology tests performed continues to increase through Fiscal Year 1995-96. This is illustrated in Table III.1 which tracks the Medical Examiner"s Office caseload that has remained relatively constant over the past three fiscal years, increasing by 633 cases or 22.79 percent, and the actual number of toxicology tests conducted on those cases, increasing by 14,298 tests, or 73.05 percent.

Table III.1
Toxicological Cases Compared to
Toxicological Tests Performed

Source: Quarterly Reports prepared by the San Francisco Medical Examiner from
Fiscal Years 1992-93 through 1995-96.

For Fiscal Years 1993-94, 1994-95 and 1995-96, the Medical Examiner"s Office reported 2,777, 3,024 and 3,153 toxicology cases, respectively. In contrast the actual number of tests conducted for the same three fiscal years were 19,573, 30,606 and 33,871 respectively. This raises the average number of tests per case from seven tests per case during Fiscal Year 1993-94 to ten tests per case during Fiscal Years 1994-95 and 11 tests per case in FY 1995-96. In contrast, during Fiscal Year 1992-93, the last fiscal year in which there was a Forensic Toxicologist, the Medical Examiner"s Office reported 6,746 toxicology cases requiring 38,945 tests. This represents an average of 6 tests per toxicology case. Reinstating the Forensic Toxicologist position would provided a greater level of management and oversight in the Toxicology Laboratory and could result in a reduction in the number of toxicology tests conducted.

Comparison of San Francisco to other Jurisdictions

To compare the number or toxicological tests conducted in the San Francisco Medical Examiner"s Office Toxicology Laboratory with other jurisdictions in California, the Budget Analyst examined the activity of toxicology laboratories in Santa Clara County, Alameda County, and Los Angeles County for Medical Examiner/Coroner cases for Fiscal Year 1995-96. To determine the number of Medical Examiner"s toxicology cases for the City and County of San Francisco, the Budget Analyst relied on the Toxicology Laboratory staff"s determination that 75 percent of the work conducted is related to Medical Examiner cases as opposed to DUI, Penal Code (PC)11550 and other toxicological testing. As such, approximately 25,403 of the 33,871 tests conducted, represented work performed for the 1,782 Medical Examiner Cases. The following table provides a comparison of the number of Medical Examiner cases, toxicological tests performed and the average number of tests per case for each of the above mentioned jurisdictions.

Table III.2
Comparison of the Number of Toxicological Tests
Performed for Medical Examiner Cases for
Selected California Jurisdiction During
Fiscal Year 1995-96

Note: For the purposes of this comparison, each jurisdiction equated one extraction to be the equivalent of one test. According to the lead toxicologists from the above mentioned laboratories, it is an inadequate measure to determine the average number of tests per case based on the number of cases and the number of tests. This is due to the variance in the testing required based on the type of case (e.g. homicide, suicide, accident, or natural) the complexity of the case, and the types of screens (analyses) each lab uses. The Budget Analyst acknowledges this limitation. However, absent any detailed information on the tests conducted by type of case, this is the best overall measure that can be used to compare the work in different jurisdictions.

Table III.2 shows that the San Francisco Medical Examiner"s Office is performing almost five times as many tests per case as Santa Clara and Alameda Counties, and almost three times as many tests per case as Los Angeles County. Increased testing requires additional staff and increases the costs of operation for Toxicology. According to the Medical Examiner"s Office staff, and assessments from independent toxicologists, the disproportionately high number of tests is attributable to a lack of communication between the pathologists and the Assistant Forensic Toxicologists, and a lack of review by a chief toxicologist or other qualified and authorized staff, of the toxicological tests requested and the actual toxicology test request forms. A review process would provide a forum for the pathologists to discuss the case with the Forensic Toxicologist, to determine the types of tests that should be conducted to obtain the required information and the most efficient method of conducting those tests. As previously noted, this could also lead to a reduction in the number of toxicological tests conducted.

By implementing a review process, the San Francisco Medical Examiner"s Office could conduct more efficient toxicology testing and assure that the tests conducted for each case are the most appropriate given the information that is needed to determine, or verify, the cause of death and contributing factors. The review process would include discussions between the lead toxicologist and the pathologist requesting the tests and a review of the Request for Toxicology Examination form submitted by the pathologist.

Changes in the Types of Toxicological Testing Requested

There also have been changes in the types of toxicological tests requested. Toxicology request forms used in the San Francisco Medical Examiner"s Office are based on three pre-set screens, or groupings of tests. The three pre-set screens used in the San Francisco Medical Examiner are:

• An "A" screen which tests for ethyl alcohol and other volatiles such as acetone and methanol;

• A "B" screen which tests for chemicals included in the "A" screen plus barbiturates, hypnotic-sedatives, benzodiazepines, and methaqualone; and

• A "C" screen which is a comprehensive screen that tests for chemicals included in both the "A" and "B" screen plus cocaine, morphine-type alkaloids, tricyclics and analytically related compounds, and phenothizine.

These screens were developed in the 1970"s, and reflect the drugs commonly tested for during that time. Since the development of these screens, there have been changes in the patterns of drug abuse and testing needs. For example, our limited sample of 50 cases between 1993 and 1996 did not include any requests for the "B" screen that was developed to detect benzodiazepines and methaqualone, along with alcohol, other volatiles and barbiturates. Forensic toxicologists in private laboratories in the San Francisco Bay Area and other jurisdictions in California stated that this is a phenomenon of changes in the use of such drugs. Since these drugs are no longer common drugs of abuse, the need to maintain a separate pre-set screen to test for their presence no longer exists.

Table III.3 Limited Sample of 50 SFME
Toxicology Cases from CY 1993 through CY 1996
by Type of Toxicology Test Screen Requested

A review of fifty case files from 1993 through 1996 revealed that 32 of the cases required some type of toxicological testing. Of the 32 cases requiring testing, 26, or 81.25 percent, of the cases were tested using "C"; screens. A total of 716 tests were run to complete theses "C" screens, or an average of 27.54 tests per case. The sample of cases that included "C" screens for toxicological testing included 3 homicides, 5 suicides, 5 naturals, 7 accidents, and 6 undetermined findings as the manner of death. The remaining 6 cases required "A" screens and specifically requested tests for "other drugs of abuse". Table III.3 above shows the distribution of the toxicology screens requested for the sample selected and the overall percentages of tests compared to cases.

The Budget Analyst acknowledges the Chief Medical Examiner"s concern about the small sample used to analyze the toxicology tests conducted by the Medical Examiner"s Office. The Budget Analyst is not drawing any causal inferences from this data and is simply noting the type of work performed. From a statistical perspective, a sample size of N=30 is statistically valid. However, a sample size of N=30 may not provide any statistically significant results. As such, the limited sample of 50 cases used for this analysis may show trends and is statistically valid. This trend is not stated with a high degree of statistical confidence, nor does the Budget Analyst claim that this limited sample is sufficient to provide any statistically significant results.

In total, the 32 toxicology cases required 835 tests. Based on this total, 85.75 percent of the tests conducted are related to requests for the comprehensive analysis provided by the "C" screen. By comparison, the San Diego County Medical Examiner"s Toxicology Laboratory, a comparable jurisdiction, reports that only 20 percent of the tests conducted are "Comprehensive", which is the equivalent of San Francisco"s "C" screen, and Los Angeles County reports that approximately 27 percent of the Coroner"s toxicology cases require a "C" or "Extended C" screen.

The Chief Toxicologist in San Diego reported that the cost and time required to provide the analysis from comprehensive, or "C" screens warrants limiting their use. For example, at an average cost of $300 per "C" screen, for the same sample of 32 cases, San Diego would expend $1,800 to conduct the tests, Los Angeles would expend $2,700 to conduct the tests, and San Francisco would expend $7,800 to conduct the tests. Based on this analysis, it is costing the City three to four times as much to conduct the same type of toxicological testing as comparable jurisdictions.

Estimating Workload and Staffing Requirements

As previously noted, there were approximately 3,153 toxicology cases during Fiscal Year 1995-96. Of these cases, 1,782 (approximately 57 percent) were Medical Examiner cases. To conduct the required toxicological analyses, the Medical Examiner"s Toxicology Laboratory is staffed with the following positions at a total cost of $365,596 for salaries and fringe benefits.

The Medical Examiner"s toxicology staff has determined that 75 percent of the tests performed in the Toxicology Laboratory are related to Medical Examiner"s cases. The Assistant Forensic Toxicologist II and one of the Assistant Forensic Toxicologist I"s are the only staff persons who perform toxicological tests for Medical Examiner"s Office cases. As such, 36.4 percent of the staff performs 75 percent of the tests. The remaining 63.6 percent of the staff is responsible for completing only 25 percent of the tests which includes testing for DUI cases, PC 11550 cases, and urinalysis for Police and Fire Department recruits. Based on information obtained from Medical Examiner"s Office staff, the toxicological testing conducted for non-Medical Examiner cases is not more difficult, nor are the tests themselves more time consuming to conduct.

Based on the reported distribution of work, the Budget Analyst considered recommending a reduction of the number of Assistant Toxicologist I positions. However, Medical Examiner staff contends that there is an excessive amount of work for the existing staff. Additionally, Pathology staff has stated that there can be a substantial period between the time toxicology tests are requested and the time results are available from the laboratory. Upon further review, and discussions with Medical Examiner"s Office staff and staff at independent toxicology laboratories, the Budget Analyst"s staff determined that recommending reductions in staffing would be premature given the inequitable distribution of the existing workload, and the segregation of testing responsibilities.

The uneven distribution of work is attributable to the lack of cross-training of the Toxicology Laboratory staff in: 1) performing all of the testing procedures conducted, and 2) the use of all laboratory equipment. In order to better utilize staff and effect a more equitable distribution of the entire workload in the Toxicology Laboratory, the Medical Examiner"s Office should utilize the expertise of the recommended Forensic Laboratory Manager/Forensic Toxicologist to develop and implement a 12 month training program for the Assistant Forensic Toxicologist I"s that will provide them with:

• The background on and knowledge of the required chemical procedures used for tests conducted in the laboratory;

• Background and training on the specific tests used to conduct all toxicological analyses; and

• An understanding of the operation of all equipment used in the laboratory to conduct such analyses.

The Forensic Laboratory Manager/Forensic Toxicologist should implement this training program within 90 days of assuming this position. The Chief Medical Examiner should make quarterly progress reports to the Director of Administrative Services on a quarterly basis as part of the current quarterly report on Medical Examiner"s Office activities.

Upon completion of this training program, the workload should be redistributed in a more equitable manner, and a thorough analysis of the real staffing requirements for the Toxicology Laboratory should be conducted. To conduct the staffing analysis, actual and projected workload and performance measures should be used. These workload and performance measures should include both quantitative and qualitative measures with regard to the number of cases or tests each Assistant Forensic Toxicologist should be able to handle, the acceptable number of errors based on the quantity of work completed and the difficulty of achieving accurate results, and the number of retests resulting from positive findings, and other reasonable performance measures used by professional forensic toxicology organizations.

The Chief Medical Examiner should continue to report toxicology workload and performance statistics as part of the regular quarterly report. Six months after the completion of the training program and redistribution of work, the Chief Medical Examiner should prepare an analysis of the staffing requirements for toxicology, to be presented to the Director of Administrative Services, that justifies the retention of 5.5 FTEs based on the workload and performance data, or, based on the same data, recommends changes in the number of Assistant Forensic Toxicologists.

Should allocating the total workload in a more equitable manner and cross-training staff create greater efficiencies. allowing the Medical Examiner"s Office to reduce the number of Assistant Forensic Toxicologist I positions, approximately $69,135 in annual savings would be generated for each position that was eliminated. Currently, of the Assistant Forensic Toxicologist Positions are filled. As such, the elimination of these positions and potential savings would have to be generated through attrition.

Review of Protocols and Quality Assurance

Observations of operations in the San Francisco Medical Examiner"s Office Toxicology Laboratory, and interviews with the staff revealed the absence of: 1) an up-to-date general procedures manual; 2) an adequate data review of toxicological tests performed; and 3) an adequate quality assurance program to ensure that the toxicological tests are performed properly and that the results are properly reported. As previously noted, these are three fundamental accreditation requirements established by the SFT/AAFS guidelines.

Inadequate General Procedures Manual and Training

The existing general procedures manual used by personnel performing toxicological analyses is obsolete. The existing "manual" consists of individual instruction sheets for different types of analyses and utilization of some of the equipment. These instruction sheets are made available for the staff to use. However, a complete manual that includes explanations of each analytical procedure performed in the laboratory that contains information on the theories and principles of the method of analysis used, instructions for the preparation of reagents, details of the analytical procedure (step by step instructions), instructions for the preparation of calibrators and controls, information about any special requirements for handling reagents or for ensuring safety and references for further information does not exist. The guidelines established by the SFT/AAFS also state that the procedure manual should contain detailed descriptions of the protocols for receiving, accessioning, and chain-of-custody for samples.

By failing to develop a detailed procedures manual for the toxicology laboratory, the staff must rely on experience and past practices to conduct analyses. This leads to inconsistency in protocol, a staff that is inadequately informed about routinely used analytical and administrative procedures and isolation of duties. Each Assistant Forensic Toxicologist is assigned to a particular type of case (e.g. medical examiner, DUI, PC 11550, etc.). The specific procedures for conducting the analyses necessary to complete such tests are known only to the staff person assigned to that particular type of case. As a result, if a particular staff member is absent, the analyses required to complete the toxicological tests assigned to that individual cannot be conducted. Additionally, the failure to provide detailed information on the use of equipment leads to even greater inefficiency.

For example, in 1989 the Medical Examiner"s Office purchased a 5890 Gas Chromatography/Mass selective detector (GC-MS) Series II at a cost of $75,000. This piece of equipment was purchased to perform comprehensive toxicological drug analyses. This is the newest GC-MS in the laboratory and it is the only instrument that is programmed to analyze biological samples for benzodiazepines, methaqualones, and amphetamines. The analyses of the above mentioned classes of drugs are included on the "C" screens, which as previously noted are requested in up to 75 percent of the Medical Examiner"s toxicology cases, or an estimated 81.25 percent of the total number of toxicological tests performed. The Assistant Forensic Toxicologist II is the only staff member who has been trained to utilized this GC-MS. There are no detailed instructions on the operation of this piece of equipment nor the tests that are performed using this particular GC-MS. Consequently, about 75 percent of the Medical Examiner"s toxicology cases, or 81.25 percent of all the toxicological tests performed, can only be completed by one staff person.

The most efficient solution to this situation is the cross-training of staff so each person is familiar with the operation of all equipment and conducting all types of analyses. Such cross-training is also indicated in the SFT/AAFS guidelines. However, in the absence of the recommended training program, competent staff with adequate technical laboratory skills could follow the instructions in the procedure manual and complete the required testing. With no cross-training, and no procedure manual, it takes a longer period of time to complete toxicological analyses. The current estimate for completing a Medical Examiner"s cases, which are all signed out pending toxicology and pathology test results, is nine days. Full utilization of staff and equipment and the development and use of a laboratory procedures manual could significantly reduce the amount of time required to complete the required toxicological examination, leading to a shorter period of time needed to complete cases.

Quality Assurance

As previously noted, the Medical Examiner"s Office is not required to obtain separate accreditation. Nevertheless, we feel that the SFT/AAFS guidelines contain useful suggestions to improve the Medical Examiner"s Office"s operations. SFT/AAFS guidelines state that a quality assurance program encompasses all aspects of the toxicological analysis process, from specimen collection and reception through analysis, data review and reporting results. The objective of a quality assurance program is to detect error, whether random or systematic, and to initiate appropriate remedial actions when errors are discovered. Quality assurance is important in forensic science disciplines, such as forensic toxicology, because the results of toxicological analysis are subject to challenge in the justice system.

The guidelines have clearly defined "standards", "calibrators", and "controls" which are the three major components used in developing a quality assurance program. These three components have been defined as follows:

In addition to these components the guidelines suggest that all labeling should be uniform for all standard reagents and that the label should include the initials of the preparer, and an expiration date furnished by the vendor or manufacture to apprise users of the useful lifetime of the standard or control.

At this time the only outside quality assurance that the Medical Examiner"s Office participates in is for DUI blood testing, as required by the State. All quality control activities are carried out by the Assistant Forensic Toxicologist II, who prepares drug standards. A chief toxicologist who, as part of their duties, would manage a quality assurance program, would improve the integrity of test results.

Although pathology staff has reported discrepancies in test results and has questioned the quality of the work that is produced in the Medical Examiner"s Toxicology Laboratory, the Budget Analyst was able to obtain only two verifiable instances where there were significant differences between the results of toxicological tests conducted by the Medical Examiner"s Office staff and the same tests conducted by an independent laboratory. This was, in part, due to the procedures used by the current staff to correct errors in test results. The manner of correcting test results makes it difficult to determine if the corrections are the result of a scrivener"s error when reporting such results, or if the values have changed as the result of a retest.

The current practice used by the Medical Examiner"s Office staff is to erase the original entries on the report and enter the new value. This is contrary to the preferred practice of maintaining the original value by lining through the entry, so it is still legible, noting the new value and dating and initialing the change. All corrections should also be noted in the laboratory"s log with information regarding the nature of the error, the date and time the error was detected, the corrective actions taken to correct the problem (especially if the error was the result of an equipment malfunction), and verification of a retest. The lack of proper notation when errors occur and are corrected makes it impossible to determine if the errors committed are random or systemic, and whether or not proper remedial actions are taken.

In telephone interviews with the Public Defender, the District Attorney and Chief Deputies of the District Attorney, each person indicated that there were no problems with the quality of the toxicological work from the Medical Examiner"s Office. However, these parties may not be aware of quality assurance weaknesses which might allow the defense (or in some cases, the prosecution) to mount serious challenges to the information presented in an adversarial judicial setting.

It should be noted that the Medical Examiner"s Office does have a Forensic Laboratory Manager (2459) position, that is responsible for reviewing quality assurance performance for the laboratory procedures. However, staff reports that the Forensic Laboratory Manager does not conduct any quality assurance reviews and is present in the laboratory for approximately one hour per week to check the laboratory"s inventory and verify supply orders.

The Medical Examiner should expand the current quality assurance program, which pertain only to DUI testing, to include all chemical analyses conducted in the toxicology laboratory. The expanded program developed by the Medical Examiner"s Office should include an outside component that uses standards from outside laboratories, which have been verified, to check their work. Greater care should be taken in correcting tests results so that any individual conducting a quality assurance review is fully aware of the number of repeated tests that are the result of an error, rather than confirming the presence of a substance. In duly noting corrections, the toxicology reports should indicate the date the error was corrected and the individual responsible for making such corrections. All repeat tests that are conducted due to equipment failure should be so noted and the manner in which the equipment failure was detected and remedied should be recorded in the laboratory"s log.

In order to begin developing procedure manuals and quality assurance measures, the Medical Examiner"s Office should conduct a thorough in-house review of the Toxicology Laboratory utilizing the expertise of the Forensic Toxicologist to:

• Evaluate the current state of the operations to determine the extent of the deficiencies;

• Provide a detailed analysis with specific steps that should be taken to remedy such deficiencies;

• Assist in the preparation of operating and procedures manuals for the various analyses conducted in the laboratory and for the operation of various laboratory equipment;

• Provide guidance in developing a quality assurance program that includes adequate case review that is tied to an adequate chain-of-custody process; and

• Provide ongoing support for the verification of standards, calibrators and controls that are prepared for the various analyses conducted.

The results of this analysis should be presented to the Director of Administrative Services along with a schedule for implementing the recommendations that are developed as a result of the review. Should the Director of Administrative Services determine that additional analysis and review is required, the City may wish to consider employing the services of an independent, licensed toxicologist, or toxicology firm, to assist in such a review.

Conclusions

The San Francisco Medical Examiner"s Office Toxicology Laboratory does not fully comply with the guidelines established by the Society of Forensic Toxicologists and the American Academy of Forensic Sciences. While the Medical Examiner"s Office is not required to seek accreditation from the Society of Forensic Toxicologists or the American Academy of Forensic Sciences, these guidelines are applicable to the Medical Examiner as it is involved in all three areas of toxicology defined in these guidelines.

The absence of a Forensic Toxicologist position appears to greatly affect the efficiency of the Toxicology Laboratory, especially with regard to providing the level of on-site supervision required by the Assistant Forensic Toxicologist I and II positions, and providing a consistent level of case review. The absence of such review, in addition to the design of the current toxicology test request form has resulted in a 73 percent increase in the number of tests conducted from 1993-94 to 1995-96.

The staff of the Toxicology Laboratory has not been adequately cross trained. Consequently, the efficiency of the Laboratory is compromised. Only certain staff members have been trained to perform certain tests and operate certain equipment causing delays in the processing of requests if that staff person in absent. Outdated procedures and the lack of comprehensive operating manuals for staff use further impact the efficiency of the Laboratory. In addition to the obsolete and incomplete procedures manuals, the Medical Examiner"s Office Toxicology Laboratory has a chain-of-custody process that is poorly coordinated with a case review process, and there is inadequate quality control and case review of the analyses conducted.

Recommendations

The Medical Examiner"s Office should:

III.1 Reinstate the position of Forensic Toxicologist to perform the technical duties of :

• conducting the more complex, toxicological studies for forensically significant drugs on blood, urine, and other physiological specimens form both decedents and individuals suspected of violating the law;

• using gas and thin layer chromatography, ultraviolet, and visible fluorescent spectrophometry;

• conducting various toxicological procedures as needed; and

• providing supervision of the laboratory staff and operating a quality assurance program which evaluates data and ensures the accuracy of the work produced, and the technical proficiency of the laboratory and staff.

III.2 Update and revise the toxicology test request form to improve the efficiency of toxicological analyses.

III.3 Evaluate the existing staff with regard to training needed to ensure that each staff member has the requisite skills to conduct all tests performed in the laboratory and that each staff member is able to operate all of the laboratory equipment.

III.4 The recommended Forensic Laboratory Manager/Forensic Toxicologist should develop and implement a training program within 90 days of assuming their position that will provide the Toxicology Laboratory staff with:

• The background on and knowledge of the required chemical procedures used for the tests conducted in the laboratory;

• Background and training on the specific tests used to conduct all toxicological analyses; and

• An understanding of the operation of all laboratory equipment used to conduct toxicological analyses.

III.5 Upon completion of the training, the workload should be redistributed in a more equitable manner and a thorough analysis of the actual staffing requirements should be conducted under the direction of the Director of Administrative Services. This staffing analysis should be based on actual and projected workload and performance data that includes both quantitative and qualitative criteria that is used and accepted by professional forensic toxicology organizations such as the Society of Forensic Toxicologists and the American Academy of Forensic Toxicology.

III.6 Upon completion of the staffing and workload analysis, the Chief Medical Examiner should prepare a report for the Director of Administrative Services that includes supporting evidence to justify the retention of 5.5 FTEs to manage the workload in the Toxicology Laboratory or, based on the same evidence, recommends changes in the number of Assistant Forensic Toxicologists.

III.7 Develop a quality assurance program that meets the standards established by the Society of Forensic Toxicologists/American Academy of Forensic Sciences guidelines and includes the verification of standards, calibrators and controls by outside laboratories.

III.8 Conduct a critical, in-house review of the operations and processes used in the Toxicology Laboratory in order to:

• Evaluate the current state of the operations to determine the extent of the deficiencies;

• Provide a detailed analysis with specific steps that should be taken to remedy such deficiencies;

• Assist in the preparation of operating and procedures manuals for the various analyses conducted in the laboratory and for the operation of various laboratory equipment;

• Provide guidance in developing a quality assurance program that includes adequate case review that is tied to the chain-of-custody process; and

• Provide ongoing support for the verification of standards, calibrators and controls that are prepared for the various analyses conducted.

Benefits/Costs

Reinstatement of the Forensic Toxicology position could be accomplished at a net cost of approximately $17,834 in salary and associated fringe benefits ($85,289 Forensic Toxicologist Salary and Fringes, less $67,455 Forensic Lab Manager Salary and Fringe Benefits), and no increase in FTEs. This position could be funded with savings obtained through the reorganization of staffing in the Medical Examiner (see Section VI: Staffing and Organization) which combines the function of the Forensic Laboratory Manager and the Forensic Toxicologist.

Should allocating the total workload in a more equitable manner and cross-training staff create greater efficiencies, allowing the Medical Examiner"s Office to reduce the number of Assistant Forensic Toxicologist I positions, approximately $69,135 in annual savings would be generated for each position that was eliminated. Currently, all of the Assistant Forensic Toxicologist Positions are filled. As such, the elimination of these positions and potential savings should be generated through attrition.

The remaining recommendations can be accomplished by existing staff and should not require additional resources.

Footnotes

1. See Forensic Toxicology Laboratory Guidelines c. 1991; published by the Society of Forensic Toxicology and the American Academy of Forensic Sciences, based upon the work of the Laboratory Guidelines Committee of the Society of Forensic Toxicologist pg. 1.

2. IBID., pg. 1

3. IBID., pg. 1

4. IBID., pg. 2

5. Forensic Toxicology Laboratory Guidelines prepared by the Society of Forensic Toxicologist, Inc. and the American Academy of Forensic Sciences, c. 1991, pg. 7.