INTRODUCTION

These guidelines, issued by the Centers for Disease Control, are directed toward all health workers, public safety workers (including emergency response employees) in the United States. They deal with

• methods to reduce the risk in the workplace of becoming infected with the etio- logic agent for acquired immune deficiency syndrome; and

• circumstances under which exposure to such etiologic agent may occur."

The purpose of this document is to provide an overview of the modes of transmission of human immunodeficiency virus (HlV) in the workplace, an assessment of the risk of transmission under various assumptions, principles underlying the control of risk, and specific risk-control recommendations for employers and workers. This document also includes information on medical management of persons who have sustained an exposure at the workplace to these viruses ( e.g., emergency medical technicians who incur a needle-stick injury while performing professional duties). These guidelines are intended for use by a technically informed audience.

lnformation on hepatitis B virus (HBV) is also presented in this document on the basis of the following assumptions:

• the modes of transmission for hepatitis B virus (HBV) are similar to those of HIV;

• the potential for HBV transmission in the occupational setting is greater than for HIV.

There is a larger body of experience relating to controlling transmission of HBV in the workplace, and general practices to prevent the transmission of HBV will also minimize the risk of transmission of HIV.

Blood-borne transmission of other pathogens not specifically addressed here will be interrupted by adherence to the precautions noted below. It is important to note that the implementation of control measures for HIV and HBV does not obviate the need for continued adherence to general infection control principles and general hygiene measures (e.g., hand washing) for preventing transmission of other infectious diseases to both worker and client.

MODES AND RISK OF VIRUS TRANSMISSION IN THE WORKPLACE

Although the potential for HBV transmission in the workplace setting is greater than for HIV, the modes of transmission for these two viruses are similar. Both have been transmitted in occupational settings only by percutaneous inoculation or contact with an open wound, nonintact (e.g., chapped, abraded, weeping, or dermatitic) skin, or mucous membranes to blood, blood-contaminated body fluids, or concentrated virus. Blood is the single most important source of HIV and HBV in the workplace setting. Protection measures against HIV and HBV for workers should focus primarily on preventing these types of exposures to blood as well as on delivery of HBV vaccination.

The risk of hepatitis B infection following a parenteral (i.e., needle stick or cut) exposure to blood is directly proportional to the probability that the blood contains hepatitis B surface antigen (HBsAg), the immunity status of the recipient, and on the efficiency of transmission. The probability of the source of the blood being HBsAg positive varies from 1 to 3 per thousand in the general population to 5%-15% in groups at high risk for HBV infection, such as immigrants from areas of high endemicity (China and Southeast Asia, sub-Saharan Africa, most Pacific islands, and the Amazon Basin); clients in institutions for the mentally retarded; intravenous drug users; homosexually active males; and household (sexual and non-sexual) contacts of HBV carriers. Of persons who have not had prior hepatitis B vaccination or postexposure prophylaxis, 6%-30% of persons who receive a needle-stick exposure from an HBsAg-positive individual will become infected.

The risk of infection with HIV following one needle-stick exposure to blood from a patient known to be infected with HIV is approximately 0.5% . This rate of transmission is considerably lower than that for HBV, probably as a result of the significantly lower concentrations of virus in the blood of HIV-infected persons. Though inadequately quantified, the risk from exposure of nonintact skin or mucous membranes is likely to be far less than that from percutaneous inoculation.

TRANSMISSION OF HEPATITIS B VIRUS TO WORKERS

Health-Care Workers

In 1987, the CDC estimated the total number of HBV infections in the United States to be 300,000 per year, with approximately 75,000 (25%) of infected persons developing acute hepatitis. Of these infected individuals, 18,000-30,000 (6%-10%) will become HBV carriers, at risk of developing chronic liver disease (chronic active hepatitis, cirrhosis, and primary liver cancer), and infectious to others.

CDC has estimated that 12,000 health-care workers whose jobs entail exposure to blood become infected with HBV each year, that 500-600 of them are hospitalized as a result of that infection, and that 700-1,200 of those infected become HBV carriers. Of the infected workers, approximately 250 will die (12-15 from fulminant hepatitis, 170-200 from cirrhosis, and 40-50 from liver cancer). Studies indicate that 10%-30% of health-care or dental workers show serologic evidence of past or present HBV infection.

Emergency Medical and Public-Safety Workers

Emergency medical workers have an increased risk for hepatitis B infection. The degree of risk correlates with the frequency and extent of blood exposure during the conduct of work activities. A few studies are available concerning risk of HBV infection for other groups of public-safety workers (law-enforcement personnel and correctional-facility workers), but reports that have been published do not document any increased risk for HBV infection. Nevertheless, in occupational settings in which workers may be routinely exposed to blood or other body fluids as described below, an increased risk for occupational acquisition of HBV infection must be assumed to be present.

Vaccination for Hepatitis B Virus

A safe and effective vaccine to prevent hepatitis B has been available since 1982. Vaccination has been recommended for health-care workers regularly exposed to blood and other body fluids potentially contaminated with HBV. In 1987, the Department of Health and Human Services and the Department of Labor stated that hepatitis B vaccine should be provided to all such workers at no charge to the worker.

Available vaccines stimulate active immunity against HBV infection and provide over 90% protection against hepatitis B for 7 or more years following vaccination. Hepatitis B vaccines also are 70%-88% effective when given within 1 week after HBV exposure. Hepatitis B immune globulin (HBIG), a preparation of immunoglobulin with high levels of antibody to HBV (anti-HBs), provides temporary passive protection following exposure to HBV. Combination treatment with hepatitis B vaccine and HBIG is over 90% effective in preventing hepatitis B following a documented exposure.

TRANSMISSION OF HUMAN IMMUNODEFICIENCY VIRUS TO WORKERS

Health-Care Workers With AIDS

As of September 19, 1988, a total of 3,182 (5.1%) of 61,929 adults with AIDS, who had been reported to the CDC national surveillance system and for whom occupational information was available, reported being employed in a health-care setting. Of the health-care workers with AIDS, 95% reported high-risk behavior; for the remaining 5% (169 workers), the means of HIV acquisition was undetermined.

Of these 169 health-care workers with AIDS with undetermined risk, information is incomplete for 28 (17%) because of death or refusal to be interviewed; 97 (57%) are still being investigated. The remaining 44 (26%) health-care workers were interviewed directly or had other follow-up information available. The occupations of these 44 were nine nursing assistants (20%); eight physicians (18%), four of whom were surgeons; eight housekeeping or maintenance workers (18%); six nurses ( 14%); four clinical laboratory technicians (9%); two respiratory therapists (5%); one dentist (2%); one paramedic (2%); one embalmer (2%); and four others who did not have contact with patients (9%). Eighteen of these 44 health-care workers reported parenteral and/or other non-needle-stick exposure to blood or other body fluids from patients in the 10 years preceding their diagnosis of AIDS. None of these exposures involved a patient with AIDS or known HIV infection, and HIV seroconversion of the health-care worker was not documented following a specific exposure.

Human Immunodeficiency Virus Transmission In The Workplace

As of July 31, 1988, 1,201 health-care workers had been enrolled and tested for HIV antibody in ongoing CDC surveillance of health-care workers exposed via needle stick or splashes to skin or mucous membranes to blood from patients known to be HIV-infected. Of 860 workers who had received needle-stick injuries or cuts with sharp objects (i.e., parenteral exposures) and whose serum had been tested for HIV antibody at least 180 days after exposure, all were positive, yielding a seroprevalence rate of 0.47% . Three of these individuals experienced an acute retroviral syndrome associated with documented seroconversion. Investigation revealed no nonoccupational risk factors for these three workers. Serum collected within 30 days of exposure was not available from the fourth person. This worker had an HIV-seropositive sexual partner, and heterosexual acquisition of infection cannot be excluded. None of the 103 workers who had contamination of mucous membranes or nonintact skin and whose serum had been tested at least 180 days after exposure developed serologic evidence of HIV infection.

Two other ongoing prospective studies assess the risk of nosocomial acquisition of HIV infection among health-care workers in the United States. As of April 1988, the National Institutes of Health had tested 983 health-care workers, 137 with documented needle-stick injuries and 345 health-care workers who had sustained mucous-membrane exposures to blood or other body fluids of HIV-infected patients; none had seroconverted (one health-care worker who subsequently experienced an occupational HIV seroconversion has since been reported from NIH). As of March 15, 1988, a similar study at the University of California of 212 health-care workers with 625 documented accidental parenteral exposures involving HIV-infected patients had identified one seroconversion following a needle stick. Prospective studies in the United Kingdom and Canada show no evidence of HIV transmission among 220 health-care workers with parenteral, mucous-membrane, or cutaneous exposures.

In addition to the health-care workers enrolled in these longitudinal surveillance studies, case histories have been published in the scientific literature for 19 HIV-infected health-care workers (13 with documented seroconversion and 6 without documented seroconversion). None of these workers reported nonoccupational risk factors.

Emergency Medical Service and Public-Safety Workers. In addition to the one paramedic with undetermined risk discussed above, three public-safety workers (law-enforcement officers) are classified in the undetermined risk group. Follow-up investigations of these workers could not determine conclusively if HIV infection was acquired during the performance of job duties.

PRINCIPLES OF INFECTION CONTROL AND THEIR APPLICATION TO HEALTH-CARE WORKERS

General Infection Control

Within the health-care setting, general infection control procedures have been developed to minimize the risk of patient acquisition of infection from contact with contaminated devices, objects, or surfaces or of transmission of an infectious agent from health-care workers to patients. Such procedures also protect workers from the risk of becoming infected. General infection-control procedures are designed to prevent transmission of a wide range of microbiological agents and to provide a wide margin of safety in the varied situations encountered in the health-care environment.

General infection-control principles are applicable to other work environments where workers contact other individuals and where transmission of infectious agents may occur. The modes of transmission noted in the hospital and medical office environment are observed in the work situations of emergency and public-safety workers, as well. Therefore, the principles of infection control developed for hospital and other health-care settings are also applicable to these work situations. Use of general infection control measures, as adapted to the work environments of emergency and public-safety workers, is important to protect both workers and individuals with whom they work from a variety of infectious agents, not just HIV and HBV.

Because emergency and public-safety workers work in environments that provide inherently unpredictable risks of exposures, general infection-control procedures should be adapted to these work situations. Exposures are unpredictable, and protective measures may often he used in situations that do not appear to present risk. Emergency and public-safety workers perform their duties in the community under extremely variable conditions; thus, control measures that are simple and uniform across all situations have the greatest likelihood of worker compliance. Administrative procedures to ensure compliance also can be more readily developed than when procedures are complex and highly variable.

Universal Blood and Body Fluid Precautions to Prevent Occupational HIV and HBV Transmission

In 1985, CDC developed the strategy of "universal blood and body fluid precautions" to address concerns regarding transmission of HIV in the health-care setting. The concept, now referred to simply as "universal precautions" stresses that all patients should be assumed to be infectious for HIV and other blood-borne pathogens. In the hospital and other health-care setting, "universal precautions" should be followed when workers are exposed to blood, certain other body fluids (amniotic fluid, pericardial fluid, peritoneal fluid, pleural fluid, synovial fluid, cerebrospinal fluid, semen, and vaginal secretions ), or any body fluid visibly contaminated with blood. Since HIV and HBV transmission has not been documented from exposure to other body fluids ( feces, nasal secretions, sputum, sweat, tears, urine, and vomitus ), "universal precautions" do not apply to these fluids. Universal precautions also do not apply to saliva, except in the dental setting, where saliva is likely to be contaminated with blood.

For the purpose of this document, human "exposure" is defined as contact with blood or other body fluids to which universal precautions apply through percutaneous inoculation or contact with an open wound, nonintact skin, or mucous membrane during the performance of normal job duties. An "exposed worker" is defined, for the purposes of this document, as an individual exposed, as described above, while performing normal job duties.

The unpredictable and emergent nature of exposures encountered by emergency and public-safety workers may make differentiation between hazardous body fluids and those which are not hazardous very difficult and often impossible. For example, poor lighting may limit the worker's ability to detect visible blood in vomitus or feces. Therefore, when emergency medical and public-safety workers encounter body fluids under uncontrolled, emergency circumstances in which differentiation between fluid types is difficult, if not impossible, they should treat all body fluids as potentially hazardous.

The application of the principles of universal precautions to the situations encountered by these workers results in the development of guidelines (listed below) for work practices, use of personal protective equipment, and other protective measures. To minimize the risks of acquiring HIV and HBV during performance of job duties, emergency and public-safety workers should be protected from exposure to blood and other body fluids as circumstances dictate. Protection can be achieved through adherence to work practices designed to minimize or eliminate exposure and through use of personal protective equipment (i.e., gloves, masks, and protective clothing) which provide a barrier between the worker and the exposure source. In some situations, redesign of selected aspects of the job through equipment modifications or environmental control can further reduce risk. These approaches to primary prevention should be used together to achieve maximal reduction of the risk of exposure.

If exposure of an individual worker occurs, medical management, consisting of collection of pertinent medical and occupational history, provision of treatment, and counseling regarding future work and personal behaviors, may reduce risk of developing disease as a result of the exposure episode. Following episodic (or continuous) exposure, decontamination and disinfection of the work environment, devices, equipment, and clothing or other forms of personal protective equipment can reduce subsequent risk of exposures. Proper disposal of contaminated waste has similar benefits.

EMPLOYER RESPONSIBILITIES

General

Detailed recommendations for employer responsibilities in protecting workers from acquisition of bloodborne diseases in the workplace have been published in the Department of Labor and Department of Health and Human Services Joint Advisory Notice and are summarized here. In developing programs to protect workers, employers should follow a series of steps: 1) classification of work activity, 2) development of standard operating procedures, 3 ) provision of training and education, 4 ) development of procedures to ensure and monitor compliance, and 5 ) workplace redesign.

As a first step, every employer should classify work activities into one of three categories of potential exposure (see Table 1). Employers should make protective equipment available to all workers when they are engaged in Category I or II activities. Employers should ensure that the appropriate protective equipment is used by workers when they perform Category I activities.

¹U.S. Department of Labor, U.S. Department of Health and Human Services. Joint advisory notice: protection against occupational exposure to hepatitis B virus (HBV) and human immunodeficiency virus (HIV). Washington, DC: US Department of Labor, US Department of Health and Human Services, 1987.

As a second step, employers should establish a detailed work practices program that includes standard operating procedures (SOPs) for all activities having the potential for exposure. Once these SOPs are developed, an initial and periodic worker education program to assure familiarity with work practices should be provided to potentially exposed workers. No worker should engage in such tasks or activities before receiving training pertaining to the SOPs, work practices, and protective equipment required for that task. Examples of personal protective equipment for the prehospital setting "defined as a setting where delivery of emergency health care takes place away from a hospital or other health-care setting) are provided in Table 2.

To facilitate and monitor compliance with SOPs, administrative procedures should be developed and records kept. Employers should monitor the workplace to ensure that required work practices are observed and that protective clothing and equipment are provided and properly used. The employer should maintain records documenting the administrative procedures used to classify job activities and copies of all SOPs for tasks or activities involving predictable or unpredictable exposure to blood or other body fluids to which universal precautions apply. In addition, training records, indicating the dates of training sessions, the content of those training sessions along with the names of all persons conducting the training, and the names of all those receiving training should also be maintained.

Whenever possible, the employer should identify devices and other approaches to modifying the work environment which will reduce exposure risk. Such approaches are desirable, since they don't require individual worker action or management activity. For example, jails and correctional facilities should have classification procedures that require the segregation of offenders who indicate through their actions or words that they intend to attack correctional-facility staff with the intent of transmitting HIV or HBV.

Medical

In addition to the general responsibilities noted above, the employer has the specific responsibility to make available to the worker a program of medical management. This program is designed to provide for the reduction of risk of infection by HBV and for counseling workers concerning issues regarding HIV and HBV. These services should be provided by a licensed health professional. All phases of medical management and counseling should ensure that the confidentiality of the worker's and client's medical data is protected.

Note: The examples provided in this table are based on application of universal precautions. Universal precautions are intended to supplement rather than replace recommendations for routine infection control, such as handwashing and using gloves to prevent gross microbial contamination of hands (e.g., contact with urine or feces).

Hepatitis B Vaccination

All workers whose jobs involve participation in tasks or activities with exposure to blood or other body fluids to which universal precautions apply should be vaccinated with hepatitis B vaccine.

Management of Percutaneous Exposure to Blood And Other Infectious Body Fluids

Once an exposure has occurred a blood sample should be drawn after consent is obtained from the individual from whom exposure occurred and tested for hepatitis B surface antigen ( HBsAg) and antibody to human immunodeficiency virus ( HIV antibody). Local laws regarding consent for testing source individuals should be followed. Policies should be available for testing source individuals in situations where consent cannot he obtained (e.g., an unconscious patient ). Testing of the source individual should be done at a location where appropriate pretest counseling is available; posttest counseling and referral for treatment should be provided.

Hepatitis B virus postexposure management

For an exposure to a source individual found to be positive for HBsAg, the worker who has not previously been given hepatitis B vaccine should receive the vaccine series. A single dose of hepatitis B immune globulin ( HBIG ) is also recommended, if this can be given within 7 days of exposure. For exposures from an HBsAg-positive source to workers who have previously received vaccine, the exposed worker should be tested for antibody to hepatitis B surface antigen (anti-HBs), and given one dose of vaccine and one dose of HBIG if the antibody level in the worker's blood sample is inadequate (i.e., < 10 SRU by RIA, negative by EIA).

If the source individual is negative for HBsAg and the worker has not been vaccinated, this opportunity should be taken to provide hepatitis B vaccination.

If the source individual refuses testing or he/she cannot he identified, the unvaccinated worker should receive the hepatitis B vaccine series. HBIG administration should be considered on an individual basis when the source individual is known or suspected to be at high risk of HBV infection. Management and treatment, if any, of previously vaccinated workers who receive an exposure from a source who refuses testing or is not identifiable should be individualized.

Human immunodeficiency virus postexposure management

For any exposure to a source individual who has AIDS, who is found to be positive for HIV infection, or who refuses testing, the worker should be counseled regarding the risk of infection and evaluated clinically and serologically for evidence of HIV infection as soon as possible after the exposure. In view of the evolving nature of HIV postexposure management, the health-care provider should be well informed of current PHS guidelines on this subject. The worker should be advised to report and seek medical evaluation for any acute febrile illness that occurs within 12 weeks after the exposure. Such an illness, particularly one characterized by fever, rash, or lymphadenopathy, may be indicative of recent HIV infection.

Following the initial test at the time of exposure, seronegative workers should be retested 6 weeks, 12 weeks, and 6 months after exposure to determine whether transmission has occurred. During this follow-up period (especially the first 6-12 weeks after exposure, when most infected persons are expected to seroconvert), exposed workers should follow U.S. Public Health Service (PHS) recommendations for preventing transmission of HIV. These include refraining from blood donation and using appropriate protection during sexual intercourse. During all phases of follow-up, it is vital that worker confidentiality be protected.

If the source individual was tested and found to be seronegative, baseline testing of the exposed worker with follow-up testing 12 weeks later may be performed if desired by the worker or recommended by the health-care provider.

If the source individual cannot be identified, decisions regarding appropriate follow-up should be individualized. Serologic testing should be made available by the employer to all workers who may be concerned they have been infected with HIV through an occupational exposure as defined above.

Management of Human Bites

On occasion, police and correctional-facility officers are intentionally bitten by suspects or prisoners. When such bites occur, routine medical and surgical therapy (including an assessment of tetanus vaccination status) should be implemented as soon as possible, since such bites frequently result in infection with organisms other than HIV and HBV. Victims of bites should be evaluated as described above for exposure to blood or other infectious body fluids.

Saliva of some persons infected with HBV has been shown to contain HBV-DNA at concentrations 1/1,000 to 1/10,000 of that found in the infected person's serum. HbsAg-positive saliva has been shown to be infectious when injected into experimental animals and in human bite exposures. However, HBsAg-positive saliva has not been shown to be infectious when applied to oral mucous membranes in experimental primate studies or through contamination of musical instruments or cardiopulmonary resuscitation dummies used by HBV carriers.

Epidemiologic studies of nonsexual household contacts of HlV-infected patients, including several small series in which HIV transmission failed to occur after bites or after percutaneous inoculation or contamination of cuts and open wounds with saliva from HlV-infected patients, suggest that the potential for salivary transmission of HIV is remote. One case report from Germany has suggested the possibility of transmission of HIV in a household setting from an infected child to a sibling through a human bite. The bite did not break the skin or result in bleeding. Since the date of seroconversion to HIV was not known for either child in this case, evidence for the role of saliva in the transmission of virus is unclear.

Documentation of Exposure and Reporting

As part of the confidential medical record, the circumstances of exposure should be recorded. Relevant information includes the activity in which the worker was engaged at the time of exposure, the extent to which appropriate work practices and protective equipment were used, and a description of the source of exposure.

Employers have a responsibility under various federal and state laws and regulations to report occupational illnesses and injuries. Existing programs in the National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services; the Bureau of Labor Statistics, Department of Labor (DOL); and the Occupational Safety and Health Administration (OSHA) receive such information for the purposes of surveillance and other objectives. Cases of infectious diseases, including AIDS and HBV infection, are reported to the Centers for Disease Control through state health departments.

Management of HBV- or HlV-infected Workers

Transmission of HBV from health-care workers to patients has been documented. Such transmission has occurred during certain types of invasive procedures (e.g., oral and gynecologic surgery) in which health-care workers, when tested, had very high concentrations of HBV in their blood (at least 100 million infectious virus particles per milliliter, a concentration much higher than occurs with HIV infection), and the health-care workers sustained a puncture wound while performing invasive procedures or had exudative or weeping lesions or microlacerations that allowed virus to contaminate instruments or open wounds of patients. A worker who is HBsAg positive and who has transmitted hepatitis B virus to another individual during the performance of his or her job duties should be excluded from the performance of those job duties which place other individuals at risk for acquisition of hepatitis B infection.

Workers with impaired immune systems resulting from HIV infection or other causes are at increased risk of acquiring or experiencing serious complications of infectious disease. Of particular concern is the risk of severe infection following exposure to other persons with infectious diseases that are easily transmitted if appropriate precautions are not taken (e.g., measles, rubella). Any worker with an impaired immune system should be counseled about the potential risk associated with providing health care to persons with any transmissible infection and should continue to follow existing recommendations for infection control to minimize risk of exposure to other infectious agents. Recommendations of the Immunization Practices Advisory Committee ( ACIP ) and institutional policies concerning requirements for vaccinating workers with live-virus vaccines ( e.g., measles, rubella ) should also be considered.

The question of whether workers infected with HIV can adequately and safely be allowed to perform patient-care duties or whether their work assignments should be changed must be determined on an individual basis. These decisions should be made by the worker's personal physician(s) in conjunction with the employer's medical advisors.

DISINFECTION, DECONTAMINATION, AND DISPOSAL

As described above, the only documented occupational risks of HIV and HBV infection are associated with parenteral (including open wound ) and mucous membrane exposure to blood and other potentially infectious body fluids. Nevertheless, the precautions described below should be routinely followed.

Needle and Sharps Disposal

All workers should take precautions to prevent injuries caused by needles, scalpel blades, and other sharp instruments or devices during procedures; when cleaning used instruments; during disposal of used needles; and when handling sharp instruments after procedures. To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand, removed from disposable syringes, or otherwise manipulated by hand. After they are used, disposable syringes and needles, scalpel blades, and other sharp items should be placed in puncture-resistant containers for disposal; the puncture-resistant containers should be located as close as practical to the use area (e.g., in the ambulance or, if sharps are carried to the scene of victim assistance from the ambulance, a small puncture-resistant container should be carried to the scene, as well). Reusable needles should be left on the syringe body and should be placed in a puncture-resistant container for transport to the reprocessing area.

Hand Washing

Hands and other skin surfaces should be washed immediately and thoroughly if contaminated with blood, other body fluids to which universal precautions apply, or potentially contaminated articles. Hands should always be washed after gloves are removed, even if the gloves appear to be intact. Hand washing should be completed using the appropriate facilities, such as utility or restroom sinks. Waterless antiseptic hand cleanser should be provided on responding units to use when hand-washing facilities are not available. When hand-washing facilities are available, wash hands with warm water and soap. When hand-washing facilities are not available, use a waterless antiseptic hand cleanser. The manufacturer's recommendations for the product should be followed.

Cleaning, Disinfecting, and Sterilizing

Table 3 presents the methods and applications for cleaning, disinfecting, and sterilizing equipment and surfaces in the prehospital setting. These methods also apply to housekeeping and other cleaning tasks.

Cleaning and Decontaminating Spills of Blood

All spills of blood and blood-contaminated fluids should be promptly cleaned up using an EPA-approved germicide or a 1:100 solution of household bleach in the following manner while wearing gloves. Visible material should first be removed with disposable towels or other appropriate means that will ensure against direct contact with blood. If splashing is anticipated, protective eyewear should be worn along with an impervious gown or apron which provides an effective barrier to splashes. The area should then be decontaminated with an appropriate germicide. Hands should be washed following removal of gloves. Soiled cleaning equipment should be cleaned and decontaminated or placed in an appropriate container and disposed of according to agency policy. Plastic bags should be available for removal of contaminated items from the site of the spill.

Shoes and boots can become contaminated with blood in certain instances. Where there is massive blood contamination on floors, the use of disposable impervious shoe coverings should be considered. Protective gloves should be worn to remove contaminated shoe coverings. The coverings and gloves should be disposed of in plastic bags. A plastic bag should be included in the crime scene kit or the car which is to be used for the disposal of contaminated items. Extra plastic bags should be stored in the police cruiser or emergency vehicle.

Laundry

Although soiled linen may be contaminated with pathogenic microorganisms, the risk of actual disease transmission is negligible. Rather than rigid procedures and specifications, hygienic storage and processing of clean and soiled linen are recommended. Laundry facilities and/or services should be made routinely available by the employer.

Sterilizations

Destroys: All forms of microbial life including high numbers of bacterial spores.

Methods: Steam under pressure (autoclave), gas (ethylene oxide), dry heat, or immersion in EPA- approved chemical "sterilant" for prolonged period of time, e.g., 6-19 hours or accord- ing to manufactures' instructions. Note: Liquid chemical "sterilants" should be used only on those instruments that are impossible to sterilize or disinfect with heat.

Use: For those instruments or devices that penetrate skin or contact normally sterile areas of the body, e.g., scalpels, needles, etc. Disposable invasive equipment eliminates the need to reprocess these types of items. When indicated, however, arrangement should be made with a health-care facility for reprocessing of reusable invasive instruments.

High-Level Disinfection

Destroys: All forms of microbial life except high numbers of bacterial spores.

Methods: Hot water pasteurization (80-100 C, 30 minutes) or exposure to an EPA-registered "sterilant" chemical as above, except for a short exposure time (10-45 minutes, or as directed by the manufacturer).

Use: For reusable instruments or devices that come into contact with mucous membranes (e.g., laryngoscope blades, endotracheal tubes, etc.)

Intermediate-Level Disinfection

Destroys: Mycobacterium tuberculosis, vegetative bacteria, most viruses, and most fungi, but does not kill bacterial spores.

Methods: EPA-registered "hospital disinfectant" chemical germicides that have a label claim for tuberculocidal activity: commercially available hard-surface germicides or solutions containing at least 500 ppm free available chlorine (a 1:100 dilution of common household bleach_approximately 1/4 cup bleach per gallon of tap water).

Use: For those surfaces that come into contact only with intact skin, e.g., stetho-scopes, blood pressure cuffs, splints, etc., and have been visibly contaminated with blood or bloody body fluids. Surfaces must be precleaned of visible material before the gemicidal chemical is applied for disinfection.

Low Level Disinfection

Destroys: Most bacteria, some viruses, some fungi, but not Mycobacterium tuberculo- sis or bacterial spores.

Methods: EPA-registered "hospital disinfectants" (no label claim for tuberculocidal activity).

Use: These agents are excellent cleaners and can be used for routine housekeeping or removal of soiling in the absence of visible blood contamination.

Environmental Disinfection

Environmental surfaces which have become soiled should be cleaned and disinfected using any cleaner or disinfectant agent which is intended for environmental use. Such surfaces include floors, woodwork, ambulance seats, countertops, etc.

Important

To assure the effectiveness of any sterilzation or disinfection process, equipment and instruments must first be thoroughly cleaned of all visible soil.

Soiled linen should be handled as little as possible and with minimum agitation to prevent gross microbial contamination of the air and of persons handling the linen. All soiled linen should be bagged at the location where it was used. Linen soiled with blood should be placed and transported in bags that prevent leakage. Normal laundry cycles should be used according to the washer and detergent manufacturers' recommendations.

Decontamination and Laundering of Protective Clothing

Protective work clothing contaminated with blood or other body fluids to which universal precautions apply should be placed and transported in bags or containers that prevent leakage. Personnel involved in the bagging, transport, and laundering of contaminated clothing should wear gloves. Protective clothing and station and work uniforms should be washed and dried according to the manufacturer's instructions. Boots and leather goods may be brush-scrubbed with soap and hot water to remove contamination.

Infective waste

The selection of procedures for disposal of infective waste is determined by the relative risk of disease transmission and application of local regulations, which vary widely. In all cases, local regulations should be consulted prior to disposal procedures and followed. Infective waste, in general, should either be incinerated or should be decontaminated before disposal in a sanitary landfill. Bulk blood, suctioned fluids, excretions, and secretions may be carefully poured down a drain connected to a sanitary sewer, where permitted. Sanitary sewers may also be used to dispose of other infectious wastes capable of being ground and flushed into the sewer, where permitted. Sharp items should be placed in puncture-proof containers and other blood-contaminated items should be placed in leakproof plastic bags for transport to an appropriate disposal location.

Prior to the removal of protective equipment, personnel remaining on the scene after the patient has been cared for should carefully search for and remove contaminated materials. Debris should be disposed of as notedabove.

Universal precautions

Under Centers for Disease Control (CDC) guidelines, blood and body fluid precautions be consistently used for all patients regardless of their bloodborne infection status. This extension of blood and body fluid precautions to all patients is referred to as "Universal Blood and Body Fluid Precautions" or "Universal Precautions." Under universal precautions, blood and certain body fluids of all patients are considered potentially infectious for human immunodeficiency virus (HIV) hepatitis B virus (HBV) and other bloodborne pathogens.

Universal precautions are intended to prevent parenteral, mucous membrane, and nonintact skin exposures of health-care workers to bloodborne pathogens. In addition, immunization with HBV vaccine is recommended as an important adjunct to universal precautions for health-care workers who have exposures to blood.

Body Fluids to Which Universal Precautions Apply

Universal precautions apply to blood and to other body fluids containing visible blood. Occupational transmission of HIV and HBV to health-care workers by blood is documented. Blood is the single most important source of HlV, HBV, and other bloodborne pathogens in the occupational setting. Infection control efforts for HlV, HBV, and other bloodborne pathogens must focus on preventing exposures to blood as well as on delivery of HBV immunization.

Universal precautions also apply to semen and vaginal secretions. Although both of these fluids have been implicated in the sexual transmission of HIV and HBV, they have not been implicated in occupational transmission from patient to health-care worker. This observation is not unexpected, since exposure to semen in the usual health-care setting is limited, and the routine practice of wearing gloves for performing vaginal examinations protects health-care workers from exposure to potentially infectious vaginal secretions.

Universal precautions also apply to tissues and to the following fluids: cerebrospinal fluid ( CSF), synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic fluid. The risk of transmission of HIV and HBV from these fluids is unknown: epidemiologic studies in the health-care and community setting are currently inadequate to assess the potential risk to health-care workers from occupational exposures to them. However, HIV has been isolated from CSF, synovial, and amniotic fluid, and HBsAg has been detected in synovial fluid, amniotic fluid, and peritoneal fluid. One case of HIV transmission was reported after a percutaneous exposure to bloody pleural fluid obtained by needle aspiration. Whereas aseptic procedures used to obtain these fluids for diagnostic or therapeutic purposes protect health-care workers from skin exposures, they cannot prevent penetrating injuries due to contaminated needles or other sharp instruments.

Body Fluids to Which Universal Precautions Do Not Apply

Universal precautions do not apply to feces, nasal secretions, sputum, sweat, tears, urine, and vomit unless they contain visible blood. The risk of transmission of HIV and HBV from these fluids and materials is extremely low or nonexistent. HIV has been isolated and HBsAg has been demonstrated in some of these fluids; however, epidemiologic studies in the health-care and community setting have not implicated these fluids or materials in the transmission of HlV and HBV infections. Some of the above fluids and excretions represent a potential source for nosocomial and community-acquired infections with other pathogens.

Precautions for Other Body Fluids in Special Settings

Human breast milk has been implicated in perinatal transmission of HIV, and HBsAg has been found in the milk of mothers infected with HBV. However, occupational exposure to human breast milk has not been implicated in the transmission of HIV nor HBV infection to health-care workers. Moreover, the health-care worker will not have the same type of intensive exposure to breast milk as the nursing neonate. Whereas universal precautions do not apply to human breast milk, gloves may he worn by health-care workers in situations where exposures to breast milk might be frequent, for example, in breast milk banking.

Saliva of some persons infected with HBV has been shown to contain HIV-DNA at concentrations 1/1,000 to 1/10,000 of that found in the infected person's serum. HbsAg-positive saliva has been shown to be infectious when injected into experimental animals and in human bite exposures. However, HBsAg-positive saliva has not been shown to be infectious when applied to oral mucous membranes in experimental primate studies, or through contamination of musical instruments or cardiopulmonary resuscitation dummies used by HIV carriers. Epidemiologic studies of nonsexual household contacts of HlV- infected patients, including several small series in which HIV transmission failed to occur after bites or after percutaneous inoculation or contamination of cuts and open wounds with saliva from HlV-infected patients, suggest that the potential for salivary transmission of HIV is remote. One case report from Germany has suggested the possibility of transmission of HIV in a household setting from an infected child to a sibling through a human bite. The bite did not break the skin or result in bleeding. Since the date of seroconversion to HIV was not known for either child in this case, evidence for the role of saliva in the transmission of virus is unclear. Another case report suggested the possibility of transmission of HIV from husband to wife by contact with saliva during kissing. However, follow-up studies did not confirm HlV infection in the wife.

Universal precautions do not apply to saliva. General infection control practices already in existence_including the use of gloves for digital examination of mucous membranes and endotracheal suctioning, and handwashing after exposure to saliva _should further minimize the minute risk, if any, for salivary transmission of HIV and HBV. Gloves need not be worn when feeding patients and when wiping saliva from the skin.

Special precautions, however, are recommended for dentistry. Occupationally-acquired infection with HBV in dental workers has been documented and two possible cases of occupationally-acquired HIV infection involving dentists have been reported. During dental procedures, contamination of saliva with blood is predictable, trauma to health-care workers' hands is common, and blood spattering may occur. Infection control precautions for dentist minimize the potential for nonintact skin and mucous membrane contact of dental health-care workers to blood-contaminated saliva of patients. In addition, the use of gloves for oral examinations and treatment in the dental setting may also protect the patient's oral mucous membranes from exposures to blood, which may occur from breaks in the skin of dental workers' hands.

Use of Protective Barriers

Protective barriers reduce the risk of exposure of the health-care worker's skin or mucous membranes to potentially infective materials. For universal precautions, protective barriers reduce the risk of exposure to blood, body fluids containing visible blood, and other fluids to which universal precautions apply. Examples of protective barriers include gloves, gowns, masks, and protective eyewear. Gloves should reduce the incidence of contamination of hands, but they cannot prevent penetrating injuries due to needles or other sharp instruments. Masks and protective eyewear or face shields should reduce the incidence of contamination of mucous membranes of the mouth, nose, and eyes.

Universal precautions are intended to supplement rather than replace recommendations for routine infection control, such as handwashing and using gloves to prevent gross microbial contamination of hands. Because specifying the types of barriers needed for every possible clinical situation is impractical, some judgment must be exercised.

The risk of nosocomial transmission of HIV, HBV, and other bloodborne pathogens can be minimized if health-care workers use the following general guidelines:

1. Take care to prevent injuries when using needles, scalpels, and other sharp instruments or devices; when handling sharp instruments after procedures; when cleaning used instruments; and when disposing of used needles. Do not recap used needles by hand; do not remove used needles from disposable syringes by hand; and do not bend, break, or otherwise manipulate used needles by hand. Place used disposable syringes and needles, scalpel blades, and other sharp items in puncture-resistant containers for disposal. Locate the puncture resistant containers as close to the use area as is practical.

2. Use protective barriers to prevent exposure to blood, body fluids containing visible blood, and other fluids to which universal precautions apply. The type of protective barrier should be appropriate for the procedure being performed and the type
of exposure anticipated.

3. Immediately and thoroughly wash hands and other skin surfaces that are contaminated with blood, body fluids containing invisible blood, or other body liquids to which universal precautions apply.

Gloves Use For Phlebotomy

Gloves should reduce the incidence of blood contamination of hands during phlebotomy

(drawing blood samples ), but they cannot prevent penetrating injures caused by needles or other sharp instruments. The likelihood of hand contamination with blood containing HIV, H BV, or other bloodborne pathogens during phlebotomy depends on several factors: 1) the skill and technique of the health-care worker, 2) the frequency with which the health-care worker performs the procedure [other factors being equal, the cumulative risk of blood exposure is higher for a health-care worker who performs more procedures ], 3 ) whether the procedure occurs in a routine or emergency situation [where blood contact may be more likely], and 4) the prevalence of infection with bloodborne pathogens in the patient population.

The likelihood of infection after skin exposure to blood containing HIV or HBV will depend on the concentration of virus (viral concentration is much higher for hepatitis B than for HIV), the duration of contact, the presence of skin lesions on the hands of the health-care worker, and—for HBV—the immune status of the health-care worker. Although not accurately quantified, the risk of HIV infection following intact skin contact with infective blood is certainly much less than the 0.5% risk following percutaneous needlestick exposures.

In universal precautions, all blood is assumed to be potentially infective for bloodborne pathogens, but in certain settings (e.g., volunteer blood-donation centers) the prevalence of infection with some blood-borne pathogens (e.g., HIV, HBV) is known to be very low. Some institutions have relaxed recommendations for using gloves for phlebotomy procedures by skilled phlebotomists in settings where the prevalence of bloodborne pathogens is known to be very low.

Institutions that judge that routine gloving for all phlebotomies is not necessary should periodically reevaluate their policy. Gloves should always be available to health-care workers who wish to use them for phlebotomy. In addition, the following general guidelines apply:

1. Use gloves for performing phlebotomy when the health-care worker has cuts, scratches, or other breaks in his/her skin.

2. Use gloves in situations where the health-care worker judges that hand contami nation with blood may occur, for example, when performing phlebotomy on an uncooperative patient

3. Use gloves for performing finger and/or heel sticks on infants and children.

4. Use gloves when persons are receiving training in phlebotomy.

Selection of Gloves

The Center for Devices and Radiological Health, FDA, has responsibility for regulating the medical glove industry. Medical gloves include those marketed as sterile surgical or nonsterile examination gloves made of vinyl or latex. General purpose utility ("rubber") gloves are also used in the health-care setting, but they are not regulated by FDA since they are not promoted for medical use. There are no reported differences in barrier effectiveness between intact latex and intact vinyl used to manufacture gloves. Thus, the type of gloves selected should be appropriate for the task being performed.

The following general guidelines are recommended:

1. Use sterile gloves for procedures involving contact with normally sterile areas of the body.

2. Use examination gloves for procedures involving contact with mucous mem branes, unless otherwise indicated, and for other patient care or diagnostic procedures that do not require the use of sterile gloves.

3. Change gloves between patient contacts.

4. Do not wash or disinfect surgical or examination gloves for reuse. Washing with surfactants may cause "winking," i.e., the enhanced penetration of liquids through undetected holes in the glove. Disinfecting agents may cause deterioration.

5. Use general-purpose utility gloves (e.g., rubber household gloves ) for house keeping chores involving potential blood contact and for instrument cleaning and decontamination procedures. Utility gloves may be decontaminated and reused but should be discarded if they are peeling, cracked, or discolored, or if they have punctures, tears, or other evidence of deterioration.

Florida Statutes on HIV/AIDS

Intent

The Legislature finds that acquired immune deficiency syndrome, otherwise known as AIDS, constitutes a serious and unique danger to the public health and welfare. The Legislature finds that acquired immune deficiency syndrome is transmitted by sexual activity, by intravenous drug use, or from an infected mother to a fetus and that public fear of contagion from casual contact is not supported by any scientific evidence.

The Legislature finds that acquired immune deficiency syndrome is transmitted by a retrovirus which makes the possibility of development of an immunization or cure highly unlikely in the near future. The Legislature finds that, once infected, there is a high probability that an individual will develop acquired immune deficiency syndrome or a related syndrome and die premature death as a result but may live productively for years in a communicable state without showing any sings or symptoms of illness.

The Legislature finds the unique methods of transmission of this disease and its inevitably fatal course have raised public fears; changed the attitudes of employers, insurers, educators, law enforcement personnel, and health and medical providers about dealing with the disease; and unexpectedly raised the medical costs of this state. The Legislature intends to establish programs and requirements related to acquired immune deficiency syndrome which carefully balance medical necessity, the right to privacy, and protection of the public from harm and which establish public programs for the care and treatment of persons with acquired immune deficiency syndrome and related conditions.

381.0034. Requirement for instruction on human immunodeficiency virus and acquired immunodeficiency syndrome

(1) As of July 2, 1991, the Department of Health shall require each person licensed or certified under chapter 401, chapter 467, part IV of chapter 468, or chapter 483, as a condition of biennial relicensure to completion of an education course re quired by the department on the modes of transmission, infection control, procedures, clinical management, and prevention of human immunodeficiency virus and acquired immunodeficiency syndrome. Such course shall include information on current Florida law on acquired immune deficiency syndrome and its impact on testing, confidentiality of test results, and treatment of patients. Each such licensee or certificateholder shall submit confirmation of having completed said course, on a form provided by the department, when submitting fees or application for each biennial renewal.

(2) Failure to complete the requirements of this section shall be grounds for disciplinary action contained in the chapters specified in subsection (1). In addition to discipline by the department, the licensee or certificateholder shall be required to complete said course.

(3) The department shall require, as a condition of granting a license under the chapters specified in subsection (1), that an applicant making initial application for licensure complete an educational course acceptable to the department on human immunodeficiency virus and acquired immune deficiency syndrome. An applicant who has not taken a course at the time of licensure, shall, upon an affidavit showing good cause, be allowed 6 months to complete this requirement.

(4) The department shall have the authority to adopt rules to carry out the provisions of this section.

(5) Any professional holding two or more licenses or certificates subject to the provisions of this section shall be permitted to show proof of having taken one department-approved course on human immunodeficiency virus and acquired immune deficiency syndrome, for purposes of relicensure or recertification for the additional licenses.

381.004. Testing for human immunodeficiency virus

(1) Legislative intent.

The Legislature finds that the use of tests designed to reveal a condition indicative of human immunodeficiency virus infection can be a valuable tool in protecting the public health. The Legislature finds that despite existing laws, regulations, and professional standards which require or promote the informed, voluntary, and confidential use of tests designed to reveal human immunodeficiency virus infection, many members of the public are deterred from seeking such testing because they misunderstand the nature of the test or fear that test results will be disclosed without their consent. The Legislature finds that the public health will be served by facilitating informed, voluntary, and confidential use of tests designed to detect human immunodeficiency virus infection.

(2) Definitions._

As used in this section:

(a) "HIV test" means a test ordered after July 6, 1988, to determine the presence of the antibody or antigen to human immunodeficiency virus or the presence of human immunodeficiency virus infection.

(b) "HIV test results" means a laboratory report of a human immunodeficiency virus test result entered into a medical record on or after July 6, 1988, or any report or notation in a medical record of a laboratory report of a human immunodeficiency virus test. As used in this section, the term "HIV test result" does not include test results reported to a health care provider by a patient.

(c) "Significant exposure" means:

1. Exposure to blood or body fluids through needlestick, instruments, or sharps;

2. Exposure of mucous membranes to visible blood or body fluids, to which universal precautions apply according to the National Centers for Disease Control and Prevention, including without limitations, the following body fluids:

a. Blood

b. Semen

c. Vaginal secretions

d. Cerebro-spinal fluid (CSF).

e. Synovial fluid

f. Pleural fluid.

g. Peritoneal fluid

h. Pericardial fluid

i. Amniotic fluid

j. Laboratory specimens that contain HIV (e.g., suspensions of concentrated virus);

3. Exposure of skin to visible blood or body fluids especially when the exposed skin is chapped, abraded, or afflicted with dermatitis or the contact is prolonged or involving an extensive area.

(d) "Test subject" or "subject of the test" means the person upon whom an HIV test is performed, or the person who has legal authority to make health care decisions for the test subject.

(3) Human immunodeficiency virus testing; informed consent; results; counseling; confidentiality._

(a) No person in this state shall perform a test designed to identify the human immunodeficiency virus, or its antigen or antibody, without first obtaining the informed consent of the person upon whom the test is being performed, except as specified in paragraph (i). Informed consent shall be preceded by an explanation of the right to confidential treatment of information identifying the subject of the test and the results of the test to the extent provided by law. Consent need not be in writing provided there is documentation in the medical record that the test has been explained and the consent has been obtained.

(b) Except as provided in paragraph (i), informed consent must be obtained from a legal guardian or other person authorized by law when the person:

1. Is not competent or is otherwise unable to make an informed judgment; or

2. Has not reached the age of majority, except as provided in s. 384.30.

(c) No person shall order a test without making available to the person tested, prior to the test, information regarding measures for the prevention of, exposure to, and transmission of human immunodeficiency virus. At the time an HIV test is ordered, the person ordering the test shall schedule a return visit with the test subject for the purpose of disclosing the test results and conducting posttest counseling as described in paragraph (e).

(d) No test result shall be determined as positive, and no positive test result shall be revealed to any person, without corroborating or confirmatory tests being conducted. However, preliminary test results may be released to licensed physicians or the medical personnel subject to the significant exposure for purposes of subparagraphs (i)10. and 11. Except as provided in this section test results are confidential and exempt from the provisions of s.119.07(1).

(e) Except as otherwise provided, no test result shall be revealed to the person upon whom the test was performed without affording that person the immediate opportunity for individual, face-to-face counseling about:

1. The meaning of the test results;

2. The possible need for additional testing;

3. Measures for the prevention of the transmission of the human immunodeficiency virus infection;

4. The availability in the geographic area of any appropriate health care services, including mental health care, and appropriate social and support services;

5. The benefits of locating and counseling any individual by whom the infected individual may have been exposed to the human immunodeficiency virus infection and any individual whom the infected individual may have exposed to such human immunodeficiency virus infection; and

6. The availability, if any, of the services of public health authorities with respect to locating and counseling any individual described in subparagraph 5.

Telephonic posttest counseling shall be permitted when reporting the HIV test results of a home access HIV test that is approved by the United States Food and Drug Administration and analyzed by a laboratory certified under the federal Clinical Laboratory Improvement Amendments of 1988 or licensed under part I of chapter 483.

(f) Except as provided in this section, the identity of any person upon whom a test has been performed and test results are confidential and exempt from the provision of s.119.07 (1). No person who has obtained or has knowledge of a test result pursuant to this section may disclose or be compelled to disclose the identity of any person upon whom a test is performed, or the results of such a test in a manner which permits identification of the subject of the tests, except to the following persons:

1. The subject of the test or the subject's legally authorized representative.

2. Any person, including third-party payors, designated in a legally effective release of the test results executed prior to or after the test by the subject of the test or the subject's legally authorized representatives. The test subject may in writing authorize the disclosure of the test subject's HIV test results to third party payors, who need not be specifically identified, and to other persons to whom the test subject subsequently issues a general release of medical information. A general release without such prior written authorization is not sufficient to release HIV test results.

3. An authorized agent or employee of a health facility or health care provider if the health facility or health care provider itself is authorized to obtain the test results, the agent or employee participates in the administration or provision of patient care or handles or processes specimens of body fluids or tissues, and the agent or employee has a need to know such information. The department shall adopt a rule defining which persons have a need to know pursuant to this subparagraph.

4. Health care providers consulting between themselves or with health care facilities to determine diagnosis and treatment. For purposes of this subparagraph health care providers shall include licensed health care professionals employed by or associated with state, county, or municipal detention facilities when such health care professionals are acting exclusively for the purpose of providing diagnosis or treatment of persons in the custody of such facilities.

5. The department, in accordance with rules for reporting and controlling the spread of disease, as otherwise provided by state law.

6. A health facility or health care provider which procures, processes, distributes, or uses: 

a. A human body part from a deceased person, with respect to medical information regarding that person; or

b. Semen provided prior to July 6, 1988, for the purpose of artificial insemination.

7. Health facility staff committees, for the purposes of conducting program monitoring, program evaluation, or services reviews pursuant to chapter 395 and 766.

8. Authorized medical or epidemiological researchers who may not further disclose any identifying charateristics or information.

9. A person allowed access by a court order which is issued in compliance with the following provisions:

a. No court of this state shall issue such order unless the court finds that the person seeking the test results has demonstrated a compelling need for the test results which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for disclosure against the privacy interest of the test subject and the public interest which may be disserved by disclosure which deters blood, organ, and semen donation and future human immunodeficiency virus-related testing or which may lead to discrimination. This paragraph shall not apply to blood bank donor records.

b. Pleadings pertaining to disclosure of test results shall substitute a pseudonym for the true name of the subject of the test. The disclosure to the parties of the subject's true name shall be communicated confidentially in documents not filed with the court.

c. Before granting any such order, the court shall provide the individual whose test result is in question with notice and a reasonable opportunity to participate in the proceedings if he or she is not already a party.

d. Court proceedings as to disclosure of test results shall be conducted in camera, unless the subject of the test agrees to a hearing in open court or unless the court determines that a public hearing is necessary to the public interest and the proper administration of justice.

e. Upon the issuance of an order to disclose test results, the court shall impose appropriate safeguards against unauthorized disclosure which shall specify the persons who may have access to the information, the purposes for which the information shall be used, and appropriate prohibitions on future disclosure.

10. A person allowed access by order of a judge of compensation claims of the Division of Workers' Compensation of the Department of Labor and Employment Security. A judge of compensation claims shall not issue such order unless he or she finds that the person seeking the test results has demonstrated a compelling need for the test results which cannot be accommodated by other means.

11. Those employees of the department or of child-placing or child-caring agencies or of family foster homes, licensed pursuant to s.409.175, who are directly involved in the placement, care, control, or custody of such test subject and who have a need to know such information; adoptive parents of such test subject; or any adult custodian, any adult relative, or any person responsible for the child's welfare, if the test subject was not tested under subparagraph (b)2, and if a reasonable attempt has been made to locate and inform the legal guardian of a test result. The department shall adopt a rule to implement this subparagraph.

12. Medical personnel who have been subject to a significant exposure during the course of medical practice or in the performance of professional duties, or individuals who are the subject of the significant exposure as provided in subparagraphs (i)10 and 11.

(g) Except as provided in this section, the identity of a person upon whom a test has been performed is confidential and exempt from the provisions of s. 119.07(1). No person to whom the results of a test have been disclosed may disclose the test results to another person except as authorized by this subsection and by ss. 951.27 and 960.003. Whenever disclosure is made pursuant to this subsection, it shall be accompanied by a statement in writing which includes the following or substantially similar language: "This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is NOT sufficient for this purpose. " An oral disclosure shall be accompanied by oral notice and followed by a written notice within 10 days, except that this notice shall not be required for disclosures made pursuant to subparagraphs (f)3., and 4.

(h) Human immunodeficiency virus test results contained in the medical records of a hospital licensed under chapter 395 may be released in accordance with s.395.3025 without being subject to the requirements of subparagraph (f)2., subparagraph (f)9., or paragraph (g); provided the hospital has obtained written informed consent for the HIV test in accordance with provisions of this section.

(i) Notwithstanding the provisions of paragraph (a), informed consent is not required:

1. When testing for sexually transmissible diseases is required by state or federal law, or by rule including the following situations:

a. HIV testing pursuant to s.796.08 of persons convicted of prostitution or of procuring another to commit prostitution.

b. Testing for HIV by a medical examiner in accordance with s. 406. 11.

2. Those exceptions provided for blood , plasma, organs, skin, semen, or other human tissue pursuant to s. 381.0041.

3. For the performance of an HIV-related test by licensed medical personnel in bona fide medical emergencies when the test results are necessary for medical diagnostic purposes to provide appropriate emergency care or treatment to the person being tested and the patient is unable to consent, as supported by documentation in the medical record. Posttest counseling is required.

4. For the performance of an HIV-related test by licensed medical personnel for medical diagnosis of acute illness where, in the opinion of the attending physician, obtaining informed consent would be detrimental to the patient, as supported by documentation in the medical record, and the test results are necessary for medical diagnostic purposes to provide appropriate care of treatment to the person being tested. Posttest counseling is required if it would not be detrimental to the patient. This subparagraph does not authorize the routine testing of patients for HIV infection without informed consent.

5. When HIV testing is performed as part of an autopsy for which consent was obtained pursuant to s.872.04.

6. For the performance of an HIV test upon a defendant pursuant to the victim's request in a prosecution for any type of sexual battery where a blood sample is taken from the defendant voluntarily pursuant to court order for any purpose, or pursuant to the provisions of s.775.0877, s.951.27, or s. 960.003; however, the results of any HIV test performed shall be disclosed solely to the victim and the defendant, except as provided in ss. 775.0877, 951.27, and 960.003.

7. When an HIV test is mandated by court order.

8. For epidemiological research pursuant to s.381.0032, for research consistent with institutional review boards created by 45 C.F.R. part 46, or for the performance of an HIV-related test for the purpose of research, if the testing is performed in a manner by which the identity of the test subject is not known and may not be retrieved by the researcher.

9. When human tissue is collected lawfully without the consent of the donor for corneal removal as authorized by s.732.9185 or enucleating of the eyes as authorized by s.732.919.

10. For the performance of an HIV test upon an individual who comes into contact with medical personnel in such a way that a significant exposure has occurred during the course of employment or within the scope of practice and where a blood sample is taken from that individual voluntarily by medical personnel for other purposes. "Medical personnel" includes a licensed or certified health care professional; an employee of a health care professional, health care facility, or blood bank; and a paramedic or emergency medical technician as defined in s.401.23.

a. Prior to performance of an HIV test on a voluntarily obtained blood sample, the individual from whom the blood was obtained shall be requested to consent to the performance of the test and to the release of the results. The individual's refusal to consent and all information concerning the performance of an HIV test and any HIV test result shall be documented only in the medical personnel's record unless, the individual gives written consent to entering this information on the individual's medical record.

b. Reasonable attempts to locate the individual and to obtain consent shall be made and all attempts must be documented. If the individual cannot be found, an HIV test may be conducted on the available blood sample. If the individual does not voluntarily consent to the performance of an HIV test, the individual shall be informed that an HIV test will be performed, and counseling shall be furnished as provided in this section. However, HIV testing shall be conducted only after a licensed physician documents in the medical record of the medical personnel, that there has been a significant exposure and that, in the physician's medical judgment, the information is medically necessary to determine the course of treatment for the medical personnel.

c. Costs of any HIV test of a blood sample performed with or without the consent of the individual, as provided in this subparagraph, shall be borne by the medical personnel or the employer of the medical personnel. However, costs of testing or treatment not directly related to the initial HIV tests or costs of subsequent testing or treatment shall not be borne by the medical personnel or the employer of the medical personnel.

d. In order to utilize the provisions of this subparagraph, the medical personnel must either be tested for HIV pursuant to this section or provide the results of an HIV test taken within 6 months prior to the significant exposures if such test results are negative.

e. A person who receives the results of an HIV test pursuant to this subparagraph shall maintain the confidentiality of the information received and of the persons tested. Such confidential information is exempt from s.119.07(1).

11. For the performance of an HIV test upon an individual who comes into contact with medical personnel in such a way that a significant exposure has occurred during the course of employment or within the scope of practice of the medical personnel while the medical personnel provides emergency medical treatment to the individual; or who comes into contact with nonmedical personnel in such a way that a significant exposure has occurred while the nonmedical personnel provides emergency medical assistance during a medical emergency. For the purpose of this subparagraph, a medical emergency means an emergency medical condition outside of a hospital or health care facility that provides physician care. The test may be performed only during the course of treatment for the medical emergency.

a. An individual who is capable of providing consent shall be requested to consent to an HIV test prior to the testing. The individual's refusal to consent, and all information concerning the performance of an HIV test and its results, shall be documented only in the medical personnel's record unless the individual gives written consent to entering this information on the individual's medical record.

b. HIV testing shall be conducted only after a licensed physician documents, in the medical record of the medical personnel or nonmedical personnel, that there has been a significant exposure and that, in the physician's medical judgment, the information is medically necessary to determine the course of treatment for the medical personnel or nonmedical personnel.

c. Costs of any HIV test performed with or without the consent of the individual, as provided in this subparagraph, shall be borne by the medical personnel or the employer of the medical personnel or nonmedical personnel. However, costs of testing or treatment not directly related to the initial HIV tests or costs of subsequent testing or treatment shall not be borne by the medical personnel or the employer of the medical personnel or nonmedical personnel.

d. In order to utilize the provisions of this subparagraph, the medical personnel or nonmedical personnel shall be tested for HIV pursuant to this section or shall provide the results of an HIV test taken within 6 months prior to the significant exposure if such test results are negative.

e. A person who receives the results of an HIV test pursuant to this subparagraph shall maintain the confidentiality of the information received and of the persons tested. Such confidential information is exempt from s.119.07(1).

12. For the performance of an HIV-related test medically indicated by licensed medical personnel for medical diagnosis of a hospitalized infant as necessary to provide appropriate care and treatment of the infant when, after a reasonable attempt, a parent cannot be contacted to provide consent. The medical records of the infant shall reflect the reason consent of the parent was not initially obtained. Test results and posttest counseling shall be provided to the parent when the parent is located.

(4) County health department network of voluntary human immunodeficiency virus testing programs._

(a) The department of Health shall establish a network of voluntary human immunodeficiency virus testing programs in every county in the state. These programs shall be conducted in each county health department established under the provisions of part I of chapter 154. Additional programs may be contracted to other private providers to the extent the finances permit and local circumstances dictate.

(b) Each county health department shall have the ability to provide counseling and testing for human immunodeficiency virus to each patient who receives services and shall offer such testing on a voluntary basis to each patient who presents himself or herself for services in a public health program designated by the State Health Officer by rule.

(c) Each county health department shall provide a program of counseling and testing for human immunodeficiency virus infection, on both an anonymous and confidental basis. Counseling provided to a patient tested on both an anonymous and confidential basis shall include informing the patient of the availability of partner-notification services, the benefits of such services, and the confidentiality protections available as part of such services. The Department of Health or its designated agent shall continue to provide for anonymous testing through an alternative testing site program with sites throughout all areas of the state. Each county health department shall maintain a list of anonymous testing sites. The list shall include the locations, phone numbers, and hours of operation of the sites and shall be disseminated to all persons and programs offering human immunodeficiency virus testing within the service area of the county health department, including physicians licensed under chapter 458 or chapter 459. Except as provided in this section, the identity of a person upon whom a test has been performed and test results are confidential and exempt from the provisions of s.119.07(1).

(d) The result of a serologic test conducted under the auspices of the Department of Health shall not be used to determine if a person may be insured for disability, health or life insurance or to screen or determine suitability for, or to discharge a person from, employment. Any person who violates the provisions of this subsection is guilty of a misdemeanor of the first degree, punishable as provided in s.775.082 or s. 775.083.

(5) Human immunodeficiency virus testing requirements; registration with the department of health; exemptions from registration._

No county health department and no other person in this state shall conduct or hold themselves out to the public as conducting a testing program for acquired immune deficiency syndrome, acquired immune deficiency syndrome related complex, or human immunodeficiency virus status without first registering with the Department of Health, complying with all other applicable provisions of state law, and meeting the following requirements:

(a) The program must be directed by a person with a minimum number of contact hours of experience in the counseling of persons with acquired immune deficiency syndrome, acquired immune deficiency syndrome related complex, or human immunodeficiency virus infection, as established by the Department of Health by rule.

(b) The program must have all medical care supervised by a physician licensed under the provisions of chapter 458 or chapter 459.

(c) The program shall have all laboratory procedures performed in a laboratory licensed under the provisions of chapter 488.

(d) The program must meet all the informed consent criteria contained in subsection (3).

(e) The program must provide pretest counseling on the meaning of a test for human immunodeficiency virus, including medical indications for the test; the possibility of false positive or false negative results; the potential need for confirmatory testing; the potential social, medical, and economic consequences of a positive test result; and the need to eliminate high-risk behavior.

(f) The program must provide supplemental corroborative testing on all positive test results before the results of any positive test are provided to the patient. Except as provided in this section, the identity of any person upon whom a test has been performed and test results are confidential and exempt from the provisions. of s.119.07(1).

(g) The program must provide face-to-face posttest counseling on the meaning of the test results; the possible need for additional testing; the social, medical, and economic consequences of a positive result; and the need to eliminate behavior which might spread the disease to others.

(h) Each person providing posttest counseling to a patient with a positive test result shall receive specialized training, to be specified by rule of the department, about the special needs of persons with positive results, including recognition of possible suicidal behavior, and shall refer the patient for further health and social services as appropriate.

(i) When services are provided for a charge during pretest counseling, testing, supplemental testing, and posttest counseling, the program must provide a complete list of all such charges to the patient and the Department of Health.

(j) Nothing in this subsection shall be construed to require a facility licensed under chapter 483 or a person licensed under the provisions of chapter 457, chapter 458, chapter 459, chapter 460, chapter 461, chapter 466, or chapter 467 to register with the Department of Health if he or she does not advertise or hold himself or herself out to the public as conducting testing programs for human immunodeficiency virus infection or specializing in such testing.

(6) Penalties.

(a) Any violation of this section by a facility or licensed health care provider shall be a ground for disciplinary action contained in the facility's or professional's respective licensing chapter.

(b) Any person who violates the confidentiality provisions of this section and s.951.27 commits a misdemeanor of the first degree, punishable as provided in s.775.082 or s. 775.083.

(7) Exemptions.

Except as provided in subsection (4)(d) and ss. 627.429 and 641.3007, insurers and others participating in activities related to the insurance application and underwriting process shall be exempt from this section.

(8)Model protocol for counseling and testing for human immunodeficiency virus._

The department of Health shall develop a model protocol consistent with the provisions of this section for counseling and testing persons for the human immunodeficiency virus.

(9) Fees.

(a) Each person or private organization registered as an AIDS or HIV testing site shall pay the department a fee which shall be set by rule of the department.

(b) Fees established pursuant to paragraph (a) shall be an amount sufficient to meet all costs incurred by the department in carrying out its registration, data collection, complaint monitoring, and administrative responsibilities under this section, for all private AIDS or HIV testing sites, but shall not exceed $100.

(c) No other fees shall be charged by other governmental agencies for these purposes.

(10) Rules.

The Department of Health may adopt such rules as are necessary to implement this section.

(11) Testing as a condition of treatment or admission._

(a) It is unlawful for any facility the operation of which, or for any person engaged in an occupation the practice of which, requires a license by the Agency for Health Care Administration, the Department of Health, or the Department of Business and Professional Regulation, to require any person to take or submit to a human immunodeficiency virus related test as a condition of admission to any such facility or as a condition of purchasing or obtaining any service or product for which the license is required. This subsection shall not be construed to prohibit any physician in good faith from declining to provide a particular treatment requested by a patient if the appropriateness of that treatment can only be determined through a human immunodeficiency virus-related test.

(b) The Agency for Health Care Administration, the Department of Health, and the Department of Business and Professional Regulation shall adopt rules implementing this subsection.

(c) Any violation of this subsection or the rules implementing it shall be punishable as provided in subsection. (6).

381.0042. Patient care of persons with human immunodeficiency virus infection

The department may establish acquired immune deficiency syndrome patient care networks in each region of the state where the number of cases of acquired immune deficiency syndrome and other human immunodeficiency virus infections justifies the establishment of cost-effective regional patient care networks. Such networks shall be delineated by rule of the department which shall take into account natural trade areas and centers of medical excellence that specialize in the treatment of acquired immune deficiency syndrome, as well as available federal, state, and other funds. Each patient care network shall include representation of persons with human immunodeficiency virus infection; health care providers; business interests; the department, including, but not limited to, county health departments; and local units of government. Each network shall plan for the care and treatment of persons with acquired immune deficiency syndrome and acquired immune deficiency syndrome related complex in a cost-effective, dignified manner which emphasizes outpatient and home care. Once each year, beginning April 1989, each network shall make its recommendations concerning the needs for patient care to the department.