Mr. Harvey Rose
Board of Supervisor"s Budget Analyst
1390 Market Street
San Francisco, CA 94102

Dear Mr. Rose:

Please find attached a copy of the response to the management audit that your Office has presented.

With the corrections noted in our response, we thank the Budget Analyst and his staff for their work and will work to implement the recommendations as appropriate.

Section I: Testing of Employees for Communicable Diseases

The OSHA Standard And The Medical Examiner"s Office"s Baseline Testing Program.

No Medical Examiner"s Office employee has ever been required, at any time, to submit to any medical procedure at the behest of the Medical Examiner"s Office, either on-site or elsewhere. The OSHA Bloodborne Pathogen Standard requires the Office to "make [hepatitis B] vaccination available at no cost, and at a reasonable time and place, to all employees who have potential exposure." Because it poses a substantial health risk to administer the hepatitis B vaccine to anyone who already has an immune reaction to hepatitis, we are therefore practically required to also make available hepatitis B screening. To be in compliance with the Standard, we must (and do) maintain records of those employees who have been vaccinated. If an employee declines to be vaccinated, we must (and do) require the employee to sign a form reflecting his or her decision. To collect the baseline blood sample for antibody testing, and, if appropriate medically, give the series of three shots over six months would take a minimum of four clinic or office visits. Performing the procedure on site saves employee time, increases productivity, and provides coordinated disease surveillance.

The Chief Medical Examiner recommends that office employees be periodically tested for other airborne and btoodbome pathogens to which they might be exposed while on the job These include other forms of hepatitis, tuberculosis, influenza, tetanus, and HIV. Your report correctly points out that the coroner"s offices in most of the other jurisdictions your team surveyed do not offer such testing and vaccination; however, you fail to note that all or nearly all of those other jurisdictions do not even have a medical examiner"s office, but instead operate a simple county coroner"s office. A county coroner is not a trained physician. Thus, the other jurisdictions you surveyed do not offer such services because they do not have the medical facilities or personnel trained to do so.

Although we never require our employees to be tested, we strongly encourage them to do so because screening serves three important functions. First, any positive test results would give the Medical Examiner an "early warning" of possible contamination problems within the office. This would allow the Medical Examiner to detect and eliminate the source of the contamination before more employees or members of the public become infected. Second, even in the case of an isolated incident of infection, early detection of a disease can stop or at least reduce the spread of, and potential damage caused by, the disease -- to the obvious benefit of our employees, their families, and the members of the public who have contact with the Office. Third, testing establishes a "baseline" for our employees; should they later become infected by one of the diseases we have tested for, this baseline will help them pursue a worker"s compensation claim. Without a baseline, the infected employee might have considerable difficulty proving that they were not already infected prior to coming to work for the office, and as a result their worker"s compensation claim could be denied outright.

Because of these substantial benefits, we endeavor to make on-site testing and vaccinations available to our staff for four reasons. First, if on-site testing is not provided, fewer employees will elect to be tested, simply because doing so would be inconvenient for them. This would be to their (and our, and the public"s) detriment. Second, to the extent employees get tested off-site, we lose considerable employee time. On-site testing takes only a few minutes, but off-site testing typically consumes up to one-third of a working day. Third, for those pathogens for which vaccinations exist, vaccinations can help to keep our staff healthy, thereby avoiding sick time (and saving the taxpayers money). Fourth, we have been informed that some of our employees would prefer not to be tested for HIV (and possibly for some other pathogens as well) by their regular healthcare providers because they are concerned that the mere fact they have asked to be tested might be disclosed to an insurance carrier and ultimately used to deny them coverage. We do not know whether this in fact happens, but the perception exists that it does, which creates a disincentive for HIV testing. On-site testing at the Medical Examiner"s Office is one of the few ways in which an employee can be tested for HIV with absolute confidence that not only the test results themselves but the fact that the test was administered will be kept rigorously confidential. (As we repeatedly explained to members of the audit team, absent a court order or voluntary disclosure by the employee, this information -- both the test results and the fact that the tests were administered -- is never made public to anyone, ever, under any circumstances.) We note that the obvious purpose of the Government Code sections cited in the report -- and particularly of section 120980, which prohibits the unauthorized disclosure of anyone"s HIV test results to any third party, and which is the @ section in the chapter which exposes a violator to possible civil damages -- is to achieve precisely this same purpose, by protecting people who might be perceived to be members of "high risk" groups from being denied access to affordable medical and life insurance coverage. Thus, if we were ordered to no longer provide this service to our employees, one of the chief objectives of Government Code sections 120875 et se . would be compromised.

The reference to the two employees who have elected to take some legal or other action is, at best, misrepresented. That the first case, the law suit, was thrown out of court as not having merit suggests strongly that the facts implied in this report are not complete or factual. It is noteworthy that the City has been awarded its costs in defending this action. Since the EEOC investigation just began, it would appear premature to suggest that it or the court appeal are likely to be successful.

Informed Consent Procedures. Recommendations I. 1, 1.3 and 1.4. of the report contain supposedly "new" or "different" procedures to ensure that employees requesting on-site tests or vaccinations are informed of the risks associated with the various vaccinations and sign appropriate consent and waiver forms. In fact, as we explained to the auditors, in early 1995 we discussed with the City Attorney our informed consent procedures and made a number of revisions to them in order to ensure that all of our employees who request on-site testing or vaccination of any kind sign the appropriate consent forms. Currently no medical test or vaccination other than tuberculosis can be administered at the Medical Examiner"s Office unless the employee who requests the test or vaccination signs an appropriate consent form, and this has been the case for the past two years. The Medical Examiner"s Office has had consent forms for HIV and other testing since the referenced law went into effect. However, we welcome your review of our informed consent procedures to make sure that they are still in compliance with all of the latest applicable codes, standards and guidelines. We will ensure that our existing policies and procedures are closely followed and that all written consent forms are placed in a secure file.

II: Sanitary Conditions and the Use of Universal Precautions

This office has been continuously accredited by NAME for over 20 years, and this includes site visits by knowledgeable inspectors. The Medical Examiner"s staff believe the cleanliness of the morgue exceeds requirements. We share the Budget Analyst"s concern that the autopsy area needs to be clean at all times and have always strived to be sure that is the case. As it states in the report, the Budget Analyst"s report was based on one initial observation which occurred when they asked to see the refrigeration units that were going to be replaced. The autopsy area was still active with 10 autopsies having been done on that day, and only one autopsy technician was on duty. The autopsy technician was cleaning as rapidly as possible and had the entire area clean and sanitary by the time she left for the evening. The Budget Analysts were asked to come back to reinspect the autopsy area multiple times but declined to do so.

We disagree with the Budget Analyst about the scientific difference between sterilization, disinfection, and decontamination. Routine sterilization is not standard or warranted in autopsy cases.

There is a significant difference between regulated waste and unregulated waste according to law. We believe that the Budget Analyst has misunderstood this difference. According to federal OSHA, regulated waste is defined as follows:

Regulated waste is to be discarded in red biohazard bags according to a specific protocol. Unregulated waste is anything other than that defined as regulated waste. It is disposed of as ordinary waste.

The Forensic Laboratory Manager has carefully researched this issue, and the policies and procedures of the department fully comply with the applicable regulations. The Medical Examiner"s Office developed "and implemented the regulated medical waste protocol years ago and meets all regulatory requirements. Records go back to its inception in July 1992 showing that all requirements have been met. Prior to January 1997 the Medical Examiner"s Office"s autopsy and laboratory specimens were interred in the same manner as human remains. Since January 1997 specimens are now defined to be medical waste and will be handled in accordance with applicable regulations.

Regarding personal protective equipment, the Bloodborne Pathogen Standard [(Sections (d)(3)(ix)(D)(4)(ii), (d)(3)(x), (d)(3)(xi), and (d)(3)(xii)] indicate that the employee is the one to judge when contamination might occur and what degree can be reasonably anticipated in determining what protective equipment to wear. The San Francisco Medical Examiner"s Office provides numerous types of this equipment to its employees, allowing them to select the specific type that they prefer to use in a potential exposure situation. For example, they provide various types of face shields (chin length, disposable lightweight, or chin length, reusable, ratchet-type, or wraparound (1/2 length) attached to a surgical-type mask), as well as other types of eye protection (goggles, glasses) which are to be worn with surgical masks. Each person may choose which type is most comfortable and provides them the degree of protection that they think appropriate for the degree of exposure anticipated. Although it is stated that employees do not wear this protective equipment during all procedures, no specific examples were provided to allow the Medical Examiner"s Office to investigate a specific allegation. It must be kept in mind, however, that each employee has the freedom to select the appropriate protective equipment to wear depending upon the procedure that they are involved with and with their best estimate of the exposure that they anticipate. To a casual observer, it might appear that an employee is not properly protected; however, the procedure being conducted may require a much lower degree of protection than another procedure being conducted in a nearby work area.

If there are instances where the Budget Analyst noted that universal precautions and established procedures were not being observed, the Department would appreciate being informed as to the specifies. Nevertheless, the Department will ensure that established procedures for universal precautions using the appropriate protective equipment are followed.

The Budget Analyst has expressed great concern over the fact that the Medical Examiner"s Office disinfects and reuses disposable needles and syringes in the autopsy room. The Office"s policy of reusing disposable needles is designed to save the taxpayers" money. It is based on years of experience, and it is fully consistent with current industry standards. The purpose behind disposable needles is not to protect the healthcare workers in the event of a needle stick (an extremely rare event, and one which is equally likely to occur with a "used" disposable or non-disposable needle), but instead to protect the patient against potential infection from an inadequately sterilized needle. In the autopsy room, of course, our "patients" are dead; thus, infection of a deceased individual is not an issue. Abandoning this practice would cost the taxpayers over $10,000 per year (increased needle costs and increased hazardous waste disposal costs) and would achieve no practical purpose. We have pointed out to the Budget Analyst that the Federal OSHA Bloodbome Pathogen Standard does not prohibit the recycling of disposable needles used on the deceased. We are aware of no other potentially applicable regulation that does, and the Budget Analyst"s audit team has not identified any. We have also checked with other medical examiners in California and elsewhere who tell us that they, too, recycle disposable needles and syringes and have been doing so for years.

If the Budget Analyst continues to be concerned about the Medical Examiner"s Office"s use of this widely accepted practice, we propose to the Board of Supervisors that the Medical Examiner"s Office host a roundtable meeting with the qualified staffs of other medical examiner"s offices and selected hospitals to discuss this issue and attempt to reach an educated decision about it. These findings would then be reviewed with applicable regulatory agencies to ensure compliance. We feel this would be wiser than simply embarking upon a plan that would cost San Francisco"s taxpayers tens of thousands of dollars per year and increase the flow of hazardous waste while doing little or nothing to mitigate the inherent dangers associated with sharps use.

A written cleaning protocol has existed since July 1992 which is followed by the staff and is monitored by spot inspections by the management staff. This protocol is consistent with the variable workload of the division The Medical Examiner"s Office will ensure that this protocol continues to be followed.

III: Toxicology

The Medical Examiner"s Office is accredited by the National Association of Medical Examiners (NAME) which accredits the entire operation, including Toxicology. We believe that the Medical Examiner"s Office is in compliance with all of the guidelines set forth by NAME. By law forensic laboratories are exempt from regulation with the sole exception of forensic alcohol analysis.

The decision to reinstate a certified forensic toxicologist position is dictated by the availability of budget funds. The Medical Examiner"s Office would welcome funding for a qualified forensic toxicologist, board certified by the American Academy of Forensic Toxicology and experienced in human forensic toxicology. This position would have to be a dedicated, full time position to allow for court appearances and preparation of protocols for improved methodology and training. At this time the Chief Medical Examiner is fulfilling these functions.

The Forensic Laboratory Manager position was developed to be a fall time manager for the labs who manages business, technical and safety compliance for all Medical Services. The Medical Examiner strongly disagrees with the assertion that "the Laboratory Manager is being underutilized." The incumbent in that position performs all the duties in that j o b description, and had to absorb many of the duties of the 1844 Management Assistant position prior to the establishment of the 1368 Special Assistant position which is taking on those responsibilities. The Controller"s Office has stated that one person cannot order items and then arrange payment for them. As a result, it has become the Laboratory Manager"s responsibility for the ordering, and the Special Assistant"s responsibility for paying the bills in compliance with the recommendations of the Controller"s Office following an audit of the Medical Examiner"s Office"s fiscal procedures in 1996.

With respect to the Budget Analyst"s recommendations concerning staffing and workload, the Medical Examiner"s Office disagrees with the Budget Analyst regarding workload distribution. The Assistant Toxicologist II position performs one step in the analysis of a majority of the Medical Examiner"s cases, however, this is only one Step out of many required to complete an analysis. The other steps are performed by the other toxicologists.

Since becoming responsible for the lab, the Chief Medical Examiner has initiated cross-training for all personnel in equipment and procedures. The Chief Medical Examiner spends a minimum of 10 to 20 hours per week in the Toxicology Laboratory overseeing its operations, tending to equipment maintenance, and developing manuals as required. While some of these hours are at nights and on weekends, a great deal of the time the Chief Medical Examiner spends in Toxicology is in the early morning hours. Since the majority of the employees in Toxicology work flex time and begin work before regular business hours, this affords the Chief Medical Examiner the opportunity to provide the level of supervisory and administrative oversight required for the efficient functioning of the lab. All of the suggested improvements have already been initiated by the Chief Medical Examiner.

It is not true that chain of possession procedures have been compromised. Chain of possession procedures are constantly reviewed and have withstood the scrutiny of criminal and civil trials for over 25 years. Chain of possession typically begins prior to evidence being under the Medical Examiner"s jurisdiction.

There is a considerable difference between quality assurance, quality control, and proficiency testing. The results from our Toxicology Lab are often retested and confirmed by other labs and are commonly confirmed.

IV: Planning and Budget

Even though the Medical Examiner"s Office"s staffing has been in flux over the last several years due to budgetary constraints, we believe that the Office has adequately met the budget requirements. We have routinely responded to all demands for budget information. The Office has managed to keep expenditures within budget while meeting all of its core functions.

However, the Department recognizes and accepts the Budget Analyst"s recommendations and will take all steps necessary to implement the recommendations in a timely fashion.

V: Medical Examiner"s Inquests

The Department notes that the Medical Examiner always notifies appropriate agencies of inquests which may be of interest to them. The Department will continue to make notification a formal policy in the future.

According to an article in the Journal of Forensic Sciences, Vol. 34:3, May 1989, p. 638, by Robert Litman, M.D., "the psychological autopsy is a procedure for evaluating after death what was on the victim"s mind before death." He also states that information in this area "is gathered from personal documents, from records such as police, medical, and Coroner"s files, and from interviews with family, friends, work, and school associates, and physicians." Our staff reports that psychological autopsies, as described by Litman, are in fact commonly performed by the Chief Medical Examiner and his staff in determination of the cause and manner of death.

The Chief Medical Examiner is a licensed physician, board certified in several specialties, with over 25 years" experience and special training in the determination of cause and manner of death. According to Section 27491 of the California Government Code, it is the duty of the coroner to determine the cause, circumstances, and manner of death. The inquest allows for the gathering of information that cannot be obtained in a psychological autopsy. Regardless of the method used, the final decision as to cause and manner is still the decision of the Chief Medical Examiner.

VI: Organization

The Mayor last year confirmed the organization of the Department of Administrative Services which includes the entire operations of the Purchaser, the County Clerk, the Department of Elections, Convention Facilities, Real Estate, Animal Care and Control, as well as the Medical Examiner and the Public Administrator/Public Guardian (PA/PG). Since the Medical Examiner and the PA/PG Offices fall under the management of the Department of Administrative Services, any organizational change can be easily accomplished administratively. While I believe the recommendations to combine certain operations of the Medical Examiner"s Office with the PA/PG have merit, I reserve the right to further study the reorganization recommendations with my staff and in the context of all the programs now under Administrative Services.

I will take the audit recommendation into consideration and in consultation with the Mayor will make any changes we feel are appropriate.

The Medical Examiner is very concerned about certain assertions in this section. The passage regarding the property control audit by the Controller does not mention that the Controller found that with the new safeguards in place, the Medical Examiner"s property and revenue money control was appropriate.

VII.1: Staff and Training: Pathology

Four out of five forensic pathologists are board certified or board eligible. The fifth staff member is verifying eligibility at this time. One staff forensic pathologist has been trained in X-ray use for many years, and one is partly trained.

The staffing level is supported by the National Association of Medical Examiners. For accreditation the Medical Examiner"s Office requires five full-time forensic pathologists in order to re-establish the training program and to handle the workload. We know from experience that three forensic pathologists are insufficient for our workload.

A review of the data shows that the comparison of the numbers of cases per position per year between the various departments around the country is not valid. We have contacted the Chiefs of several of the referenced jurisdictions and found that the Budget Analyst counted every death reported to them as a case without differentiating jurisdictional and non-jurisdictional cases. If the same method were applied in San Francisco, each pathologist would have handled approximately 1,000 cases per year, not 320. The Department will review the Forensic Pathologist job description in conjunction with the Department of Human Resources and will make changes as appropriate.

VII.2: Staff and Training: Investigations

The Department disagrees with the Budget Analyst"s recommendation to reduce the number of Medical Examiner"s Investigator positions by one. The Medical Examiner has experience with working with one less deputy and has found that it is not practical because it increases overtime costs. The Paramedic Division agreed to answer the Medical Examiner"s phones on the midnight shift for a maximum of five hours per night when the police found it to be too time-consuming for their dispatchers. The paramedics agreed to this because the period from midnight to 5 a.m. is their and the Medical Examiner"s slowest time. The Chief Medical Examiner and Administrative Coroner are usually at work by 5 a.m. or shortly thereafter and can answer the phones at that time if the investigators are on a call. It would not be fair to ask the paramedics to answer the phones from 4 p.m. until 8 a.m. every night, since the phones are typically extremely busy during the 4 p.m. to 12 midnight shift for both the paramedics and the Medical Examiner. Also, the paramedics have no access to any records in the Medical Examiner"s Office, meaning that they cannot furnish information to anyone, including grieving families calling for information regarding a deceased person. The Paramedic Division will soon become part of the Fire Department, and following this change, there are no guarantees that the Medical Examiner"s Office will have the assistance of the Paramedic Division for answering phones.

The Medical Examiner"s Office has previously requested the Department of Human Resources to create a new classification for the as-needed Investigators so that when these persons are used to fill in for full-time Investigators, they are paid an entry level salary rather than the same as the full-time permanent Investigators.

The Medical Examiner"s Office already has in place a plan for training of Investigators, and all full-time. permanent Investigators have received training in the suggested areas and more. Since our investigators have received Peace Officer Specialized Training (P.O.S.T.) certification, this training can be paid entirely from the P.O.S.T. funds at no cost to the citizens of San Francisco.

VII.3: Staff and Training: Toxicology

The Budget Analyst has either misinterpreted or been misinformed about the division of labor in the Toxicology Laboratory. Identification and quantitation of a drug involves numerous steps performed by different toxicology staff members. The staff is continuously undergoing training. All forensic toxicology staff have baccalaureate or advanced degrees. All have over 17 years" experience in human and forensic toxicology.

The Chief Medical Examiner is board certified in clinical and forensic pathology with over 15 years" experience as the medical director of an acute toxicology laboratory and over 25 years in forensic toxicology.

Based on review of the SOFT membership requirements, all Toxicology personnel would be eligible for full SOFT membership. Using SOFT guidelines, not only the Forensic Laboratory Manager, but also the Chief Medical Examiner and the Assistant Toxicologist II all meet SOFT requirements for the director of the laboratory.

However, the Medical Examiner"s Office will review all laboratory job descriptions in conjunction with the Department of Human Resources.

Please feel free to contact me directly to discuss the report and/or our response.

Sincerely,

Director of Administrative Services