The Center for Disease Control (CDC) and the United States Department of Labor"s Occupational Safety and Health Administration (OSHA) have established guidelines and rules, respectively, for use in medical settings to reduce and prevent the spread of HIV and other infectious diseases caused by bloodborne pathogens. Federal OSHA regulations were promulgated in December of 1991. These rules amended Part 1910 of Title 29 of the Code of Federal Regulations (CFR) by adding Section 1910.1030.

Parameters of Section 1910.1030

To provide the level of clarity needed to implement universal precautions used in reducing and preventing the spread of HIV and other infectious diseases, the CFR contains definitions that establish who is affected by these rules, what situations the CDC rules apply in, and what constitutes exposure to bloodborne pathogens. Based on the rules, as promulgated, it is not necessary to know, definitively, that HIV or any other bloodborne pathogenic microorganism is present in the human blood or human blood components to consider a surface contaminated. The mere presence, of blood, or reasonable expectation of the presence of blood, or any other potentially infectious materials on a surface constitutes contamination.

The Medical Examiner"s Office is subject to Section 1910.1030 of Title 29 of the CFR since it meets many of the conditions defined in this section. The Medical Examiner"s Office:

• Is a workplace where diagnostic and other screening procedures are performed on blood or other potentially infectious materials;

• Requires staff to work with contaminated objects that can penetrate the skin including but not limited to needles, scalpels, and other implements; and

• Employees are at risk of occupational exposure due to reasonably anticipated skin, eye, mucous membrane or other parenteral contact with blood, or other potentially infectious materials that may result from the performance of an employee"s duties. [1]

Since these conditions exist, the Medical Examiner"s Office is required, by these OSHA rules, to establish a written Exposure Control Plan that will eliminate or minimize employee exposure to potentially infectious materials and safeguard employees from accidental cuts and punctures that could transmit infectious microorganisms.

The rules and regulations also state that the employer (Medical Examiner"s Office) shall provide, at no cost to the employee, protective equipment such as, but not limited to: gowns; gloves, laboratory coats, face shields, or masks; and eye protection. Although the Medical Examiner"s Office is in compliance with this regulation by providing such specified protective equipment, these regulations are not enforced.

The employer is to ensure that the protective equipment is used unless extraordinary conditions exits which would prevent the delivery of health care or public safety services, or would have posed an increased hazard to the safety of the worker or co-worker. It is also the responsibility of the employer to make sure that a full investigation into the circumstances preventing the use of protective equipment is held whenever an employee makes a decision not to wear such protective equipment. Steps must be taken to document the circumstances and conditions leading to the infraction of the rules, and the employer must determine whether changes can be implemented to avoid the same, or similar, circumstances and conditions in the future.

Finally, general housekeeping precepts are outlined. The CFR clearly states that employers are to keep the worksite in a clean and sanitary condition. This includes writing and implementing an appropriate schedule for cleaning the worksite and methods of decontaminating surfaces based on the location within the worksite, the type of surface to be decontaminated, the type of soil that is present and the tasks or procedures that are performed in the area.

Medical Examiner"s Office"s Compliance with CFR Rules and Regulations

To respond to the rules and regulations promulgated by the federal OSHA, the San Francisco Medical Examiner"s Office prepared and implemented an Exposure Control Plan (ECP) that became effective May 5, 1992. Such plan was revised October 22, 1996. In this ECP, the Medical Examiner"s Office: identifies all personnel that are affected by the conditions set forth in the federal OSHA standards; states that there are sanctions for non-compliance with the ECP as implemented and revised; sets forth policy and practices for the use of Universal Precautions; identifies personal protective equipment to be used in procedures; lists general safety precautions to be used in the work place; sets forth safe work practices by task; outlines general housekeeping procedures and practices; and communication of hazards to employees (e.g. labeling of containers, specimen and waste).

By developing this ECP, the Medical Examiner"s Office is in compliance with the letter of the regulations. However, practices, reported by staff and observed by the Budget Analyst, indicate that compliance with the ECP is not enforced.

General Conditions on the Service Floor of the Medical Examiner"s Morgue Facility

The Budget Analyst"s staff requested a walk through of the facility as part of the field work for this management audit. At the time of the walk through, the Administrative Coroner stated that the facility adheres to universal infection control standards. However, the condition of the service floor and storage area did not appear to meet the standards set forth in the ECP nor those in Section 1910.1030 of Title 29 of the CFR.

The Budget Analyst"s initial inspection of the service floor, including refrigeration and storage areas, raised concerns regarding general cleanliness. This initial inspection revealed that:

• The terrazzo floor was stained and had small amounts of standing fluid in some areas, and the flooring is cracked which provides a potential place for harboring bacteria;

• The outside of the stainless steel refrigeration units did not look like they had been cleaned regularly and were particularly dirty around the door handles, and gurneys and other equipment were strewn haphazardly throughout each of the refrigeration units;

• The flush disposal bowls below autopsy tables were either dirty or stained indicating that they are not currently cleaned on a regular basis, or may not have been cleaned regularly, in the past;[2]

• Three, wheeled tables were stacked with containers storing body specimen in formaldehyde, two high on the bottom shelf and three high on the top shelf and looked unstable and likely to topple if there was a significant disturbance such as an earthquake or an individual falling or bumping into the tables; and

• Three other wheeled tables were piled with blood-stained and otherwise contaminated clothing "temporarily until they can be bundled and sent over to the police evidence room."

Based on the conditions found during the walk-through of the service floor and storage area, the Budget Analyst staff concluded that sanitary conditions could be improved. Medical Examiner"s Office staff also acknowledges infractions of universal precaution protocol. To their knowledge, no one on the Medical Examiner"s Office staff regularly monitors adherence to universal precautions and infection control.

In a letter dated March 31, 1997 to the Budget Analyst, the Chief Medical Examiner states:

The regulations in the CFR regarding the use of protective clothing and other protective devices clearly state that the only time universal precautions should not be followed is when there is a threat to the safety of the worker or the public. The CFR also states that any time such precautions are not observed the employer is to investigate the reason the precautions were not observed and develop alternative procedures to use in the future that will allow staff to use such precautions in the future.

Adoption of Protocols to Exercise Universal Infection Controls and Precautions

The rules adopted by OSHA are for the protection of the employees who work in environments that potentially expose those employees to bloodborne pathogens and other pathogenic microorganisms. As previously noted, to comply with the OSHA rules, the Medical Examiner"s Office prepared and approved an Exposure Control Plan, effective May 5, 1992 and revised this plan, effective October 22, 1996. While the Exposure Control Plan prepared and adopted by the Medical Examiner"s Office clearly addresses all of the areas of the OSHA rules, the procedures are not enforced.

The Forensic Lab Manager is responsible for ensuring that all employees adhere to the Exposure Control Plan and that universal precautions are observed. However, the Forensic Lab Manager does not routinely observe procedures in the laboratories nor monitor autopsy procedures to ensure that the pathologists are following the guidelines set forth in the OSHA rules and Exposure Control Plan. By their own admission, the pathologists do not always wear masks, do not always wear protective gowns and sleeve guards, and do not always use the recommended ten percent bleach solution for cleaning instruments. In addition to information provided by staff in interviews, the Budget Analyst"s staff observed:

• Autopsy Technicians frequently leave the autopsy area in their "greens" which are worn during autopsy procedures;

• Regulated waste (waste contaminated with blood and other body fluids) was not properly labeled or placed in red bags (indicating that regulated or possibly contaminated waste is being disposed of), or disposed of in a appropriate manner;

• Needles used to aspirate fluids are stored in the autopsy area in sponges that are sitting on counters (work surfaces) to be reused; and

• Laboratory work areas (both Toxicology and Pathology) were generally unclean.

Other concerns with regard to compliance with OSHA rules include individuals walking through the autopsy area with open beverage containers, individuals entering the autopsy area without the proper protective clothing, only rinsing instruments in water between cases, and no inspection of area or procedures to document the use or violation of universal precautions in laboratory and autopsy areas. Compliance with all applicable OSHA rules is important to decrease the risk of infection from bloodborne pathogens (specifically HIV and Hepatitis B), and other pathogenic microorganisms.

Reuse of Needles and other Sharps

The reuse of disposable needles and the methods used for cleaning and storing such needles also raised concerns. The OSHA rules for the reuse of needles clearly state:

The current procedures used by the Medical Examiner"s Office staff for cleaning needles, requires that the employee handle the needle several times removing it from, and replacing it on the syringe. Each time the needle is handled the chance of an accidental "needle stick" increases. Medical Examiner"s Office staff discards the needle caps when the needle is opened for use. As such, there is no possibility of recapping the needles. Since it is the policy of the Medical Examiner"s Office to reuse needles, the rules, promulgated by OSHA (mechanical device to remove needles and to recap needles, or one handed recapping) should be followed rigorously.

Inserting needles in sponges and storing those needles on counters in the autopsy area workspace does not, meet the standard set by OSHA. This practice also does not meet the CDC Guidelines for Prevention of HIV Transmission. Both OSHA and the CDC clearly state that reusable needles are not to be recapped except by mechanical means or one-handed methods, and that all needles, scalpel blades, and other sharps are to be placed in a puncture resistant container immediately after use. The CDC Guidelines for Prevention of HIV Transmission are posted in the Medical Examiner. However, the Chief Medical Examiner and the Forensic Laboratory Manager must take active steps to enforce the OSHA rules regarding reusing and recapping needles. Such steps should include:,ul>

• Only using disposable needles once prior to discarding them in an appropriate manner;

• Using mechanical devices and one-handed techniques for removing reusable needles from syringes, and also using mechanical devices or proper one-handed techniques for recapping reusable needles; and

• Properly disassembling, cleaning and sterilizing syringes that are to be reused for subsequent procedures.

Information obtained from San Jose Surgical Supply Company indicates that the Medical Examiner"s Office could implement a policy of discarding disposable needles after each use for a cost of approximately $9,948annually. This estimate is based on quantities and prices shown in Table II.1.

Table II.1
Estimated Cost of Disposable
Needles and Syringes

The Chief Medical Examiner indicates that implementing a policy of using disposable needles only once and discarding them after that use also will increase expenditures for sharps disposal. In addition to the estimated $9,948 for the needles and syringes, costs for sharps containers and a disposal contract must be considered. Under the current practice, the Medical Examiner"s Office can obtain a permit as an entity that disposes of less than 20 pounds of waste per week. Under the proposed practice, the Medical Examiner states that a contract for the disposal of medical waste would be required as the amount of wasted discarded would exceed the 20 pound limit.

Disposal of Regulated Waste

Additionally, the manner in which potentially infectious biologically hazardous waste is discarded does not appear to meet the set standards. The OSHA regulations on the disposal of contaminated or "regulated" waste is very clear. In fact, OSHA has differentiated between the disposal of contaminated sharps and other waste. The Medical Examiner"s Office is generally in compliance with the regulations regarding the disposal of contaminated sharps. However based on information obtained from the Medical Examiner"s Office staff and observations by the Budget Analyst"s staff, the Office should ensure that it is in compliance with regard to the disposal of "other regulated waste". The regulation specifically states:

The Medical Examiner"s Office currently disposes of waste from the autopsy area in grey garbage sacks. These sacks are filled with refuse from the medical procedures (Intravenous Bags, catheters, and other evidence of medical procedures), along with other waste from the autopsy area. These bags are then removed by the Forensic Autopsy Technicians.

According to the State of California regulations for the disposal of biologically hazardous waste, any waste that is contaminated with biologically hazardous materials, must be disposed of in an appropriate manner. While the definition of contaminated waste differs, the intent does not. All waste must be identified and tagged prior to disposal. Additionally, the materials must be disposed of in a container, or containers that remain clearly marked. Transport of such waste must be made by duly licensed and regulated disposal contractors, or by agencies holding the appropriate permits.

Again, it is incumbent upon the Chief Medical Examiner to ensure that his staff is in compliance with all state and federal regulations regarding the disposal of all materials that are potentially contaminated with biologically hazardous waste. Compliance can be accomplished by properly tagging waste and completing the applications for the appropriate disposal and transport permits.

It should be noted that the Environment Health Division of the Department of Health inspected the Medical Examiner"s Office facility and conducted a cursory review of disposal practices. During the site visit, the service floor (autopsy area) was in use and the inspector met with the Medical Examiner"s Office Laboratory Manager who stated that there was no disposal of regulated waste in grey trash bags and that "medical waste" is transported to San Francisco General Hospital, and disposed of in an appropriate manner. This information is a direct contradiction of the information provided by staff that perform procedures in the autopsy room.

The Budget Analyst requested a list of all contracts the Medical Examiner"s Office has for outside services. The list provided does not include a contract for the removal of regulated or medical waste. The Medical Examiner"s Office admits that it does not have the appropriate permits to transport medical waste and thus, is not in compliance with the California Medical Waste Disposal Act. However, the Medical Examiner"s Office is working with Environmental Health to obtain the proper permits and bring its waste transport and disposal into compliance.

General Housekeepingˆ

As previously noted, the general conditions on the service floor of the Medical Examiner"s Office revealed a lack of cleanliness. The conditions listed above may indicate the Medical Examiner"s Office is not cleaning thoroughly or frequently enough. The OSHA rules generally state:

• "Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present and tasks or procedures being performed in the area."

• "All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials." and

• "Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning."

The Budget Analyst"s initial inspection of the service area of the Medical Examiner established that the area is not cleaned and decontaminated on a daily basis. Also, while the Medical Examiner"s Office has developed an Exposure Control Plan, that plan does not contain a cleaning schedule with sufficient detail. For example, the plan reads,

These instructions for cleaning the autopsy room walls and the build-up of grime and blood stains do suggest frequent, or "at least weekly" cleaning. However, this is not a specific schedule which staff can easily follow. Also the only section that specifies the type of disinfectant cleaning solution that should be used in the section pertaining to the cleaning of the laboratories and laboratory equipment. Other sections, (laboratory glassware, isolation room and isolation room equipment, autopsy room and equipment, etc.) simply note that a strong, or appropriate disinfectant should be used.

In order to advise staff of housekeeping requirements in a clear and precise manner, a schedule should be developed that specifies:

• The days on which cleaning is to occur. For example: "Each Wednesday afternoon, the Formica walls in the autopsy room are to be washed. The remaining portion of the walls in the autopsy room are to be washed the third Wednesday of each month, and any time there is visible soil."

• The types of cleaning solutions and disinfectants that should be used. For example: "The Formica walls should be washed with a solution of alconox and water. This cleaning solution shall be mixed at a ratio of 1/4 cup alconox to 3 gallons of hot water." and

• The steps in the cleaning process. For example: "The walls are to be washed with the solution of alconox and water until all visible signs of soil have been removed. The initial washing should be followed with a second washing with the same solution. The walls should then be rinsed with clear, hot water, sprayed with a disinfectant and left to air dry."

Additionally, the schedules should indicate who is responsible for completing each task, who is to supervise and the level of supervision to be provided, and who is responsible for inspecting areas to make sure that all of the cleaning tasks are accomplished as scheduled.

Adherence to the procedures outlined in the revised Exposure Control Plan must be verified through the implementation of inspections of work areas, and observations of pathology and laboratory staff during autopsy and laboratory procedures. The inspections should be conducted on both a scheduled and unscheduled basis. Scheduled inspections should be used to determine what types of changes in housekeeping, medical, and laboratory testing protocols should be made in order to make adhering to universal precautions as easy as possible. The unscheduled inspections should be use to verify that all stated protocols are being followed and that universal precautions are being used at all times.

Impact of Current Practices on Samples Used as Evidence

Universal precautions have been developed and are implemented to reduce the risk of infections spread by bloodborne pathogens and other pathogenic microorganisms from patient to patient, or staff to patient. In medical examiner and coroner offices, the risk of infection is to employees as opposed to living patients, and from staff to staff. In addition, failure to properly clean and sterilize instruments used to obtain samples and conduct toxicology tests could affect the quality of samples used in such tests.

In order to properly clean autopsy room equipment, and especially needles and syringes, the entire device must be disassembled. Disassembling the equipment is time consuming and exposes staff to the risk of infection through needle sticks, scrapes and cuts.

Medical Examiner"s Office staff reports that scalpels, needles, syringes and knives are not always properly cleaned between cases. Pathologist stated that this can lead to the possibility of contaminating samples when moving from one case to the next. Such contamination could become a significant issue in cases where legal actions are pending. For example, blood samples from Case "A" that are contaminated with blood or other fluids from Case "B" could falsely indicate the presence of a substance. It is also possible that chemicals and disinfectants used to clean equipment, such as syringes and needles, could skew the results of some toxicological tests.

The Chief Medical Examiner states that the possibility of such contamination is remote. While this may be true, in a high profile case, the Defense Bar need only suggest that the protocol used in the autopsy room and laboratory provide the opportunity for contamination. This could be enough to seriously jeopardize the District Attorney"s ability to successful prosecute a case.

The Budget Analyst has not found any instance where such contamination has taken place. However, such instances have occurred in other jurisdictions. Adopting more stringent protocol with regard to the cleaning and sterilization of autopsy room and laboratory instruments would greatly reduce, and possibly eliminate, the possibility of such an occurrence.

Conclusions

The United States Department of Labor"s Occupational Safety and Health Administration, and the Center for Disease Control have issued rules and guidelines for the prevention of HIV transmission, and other bloodborne pathogens and pathogenic microorganisms. These rules were promulgated to safeguard employees who are required to work under conditions where the possibility of contamination exists. In order to comply with these rules and guidelines, the Medical Examiner developed and approved an Exposure Control Plan to be used by the staff.

Based on the observations of the laboratories and autopsy area, and despite the development and approval of an Exposure Control Plan, the Budget Analyst has concluded that the standards specified by OSHA and the CDC are not strictly adhered to and that the Medical Examiner"s Office could improve the sanitary conditions of the facility. The lack of adherence to universal precautions with respect to using protective clothing and masks, as well as the failure to properly clean disinfect or sterilize instruments and work areas, is further evidence of the Medical Examiner"s laxity in enforcing the approved Exposure Control Plan.

The failure to adhere to universal precautions and the approved Exposure Control Plan increases the risk of exposure to bloodborne pathogens and other pathogenic microorganisms in the work environment. Increased exposure to bloodborne pathogens and other pathogenic microorganisms result from the conditions found in the autopsy, storage and laboratory areas of the Medical Examiner"s Office.

In order to reduce the risk of exposure faced by employees, the Medical Examiner"s Office should devise a plan to conduct inspections of all work areas where exposure and contamination could occur to ensure that all employees are observing the OSHA regulations regarding protective equipment, clothing and procedures. The inspections also should include monitoring general housekeeping to ensure that the service floor and storage areas are sanitary, and verification that all biologically hazardous waste is properly discarded and disposed of in a manner that is consistent with state regulations. Additionally, the Medical Examiner"s Office should implement new policies with regard to the reuse of needles and syringes and strictly enforce the OSHA regulation on the recapping of needles.

Recommendations

To ensure that all protocol adhere to the Universal Precautions outlined in the OSHA rules regarding Occupational Exposure to Bloodborne Pathogens, promulgated December 6, 1991, the Medical Examiner"s Office should:

II.1 Enforce established protocols and generally adhere to the universal infection control and sanitary condition standards that are outlined in the Code of Federal Regulations publication announcing the OSHA rules.

II.2 Actively enforce the OSHA rules regarding the reuse of syringes and recapping of needles by:

II.3 Comply with all State and Federal regulations regarding the disposal of regulated waste and develop a method of providing proof of such compliance. Proof could be obtained by:

II.4 Revise the Housekeeping section of the Exposure Control Plan to include a specific schedule for cleaning all areas and equipment on the service floor of the Medical Examiner"s Office and laboratories. The revisions should include:

II.5 Assign specific staff to supervise and ensure the cleaning of specific areas of the service floor and develop a schedule for inspecting the service floor, including laboratories, to verify compliance with universal infection control and sanitary conditions, outlined in the OSHA Occupational Exposure to Bloodborne Pathogens; Final Rule dated December 6, 1991.

Costs/Benefits

Adopting a policy to use disposable needles once prior to discarding them could be implemented at an estimated annual cost of $9,950. Based on financial data obtained from the FY 1995-96 year-end reports, these expenditures could be absorbed within the existing budget.

Complying with the OSHA regulations and CDC guidelines for observing universal precautions, the City can reduce its risk of accidental infections caused by needle sticks and other forms of inoculation (e.g. touching contaminated surfaces, splatter from blood and other body fluids, etc.). Reducing the risk of accidental infection also reduces the potential for legal actions, filed by employees who are accidentally inoculated with bloodborne pathogens and other pathogenic microorganisms found in their work place.

Footnotes

1. See Occupational Exposure to Bloodborne Pathogens; Final Rule December 6, 1991.

2. The Department indicates that these bowls are rust stained.