STD clinics should be prepared for medical emergencies, particularly
life-threatening drug reactions of patients and occupational exposures that
may place health care workers at risk for acquiring any bloodborne infections,
including HIV. Each clinic should have established procedures, adequate and
properly maintained equipment, and appropriately trained staff. Each clinic
should have a written protocol for prompt reporting, evaluation, counseling,
treatment, and follow up of occupational exposures (CDC, 1998).
Recommendations
One copy of an emergency protocol should be kept in the clinic
manual and one copy with the emergency supplies.
Emergency equipment, supplies, and medications should be
updated frequently according to an established schedule to ensure that they
are not depleted or expired. Emergency supplies should be sealed when not
in use.
All clinical staff members should be trained in cardiopulmonary
resuscitation and should be able to respond appropriately in an emergency.
Staff members should be trained in specific safety procedures
for managing potentially violent or abusive persons in the clinic.
Mock emergency drills should be held at least twice yearly
to ensure that all staff members recognize emergencies, know their roles
and responsibilities, know the location and contents of emergency supplies,
can use all equipment properly, and follow established protocols.
STD prevention programs should develop and implement policies
and procedures to manage occupational exposures of health care workers.
STAT LABORATORY MANAGEMENT STRUCTURE
An on-site laboratory prepared to perform immediate (stat), high
quality testing to assist with the diagnosis of various STDs is an indispensable
component of any STD clinic. Results of stat tests should be given to the patient
during the clinic visit. Links should be established or maintained with reference
laboratories for non-routine or special testing to provide comprehensive coverage
for clinical services. For information on commonly used stat tests, see Appendices
ML-B through ML-E. All laboratories must comply with state and federal regulations
governing diagnostic testing. The laboratory director may be on site or at
the state or local health department for laboratories that have the exemption
for limited public health testing (see Appendix
ML-A).
The use of point-of-care tests can have significant treatment
and economic benefit in populations in which follow-up treatment rates are
relatively low. How much benefit they have relative to the use of other tests
depends upon their performance characteristics and cost, and the notification
and treatment rates that would occur if other tests were used.
Some laboratories take advantage of the relative performance
simplicity of the point-of-care tests and "batch" tests from individual
patients together, performing them after the patient has left. The performance
characteristics of point-of-care tests are often not as good as other tests,
lessening their comparative advantage. In such instances as these, use of the
tests is justified only when positive results are available to permit diagnosis
of patients at the time of their visit.
Clinic laboratorians should have access to a brightfield microscope.
In addition, laboratorians in those clinics where rapid syphilis diagnosis
is important, should have available at least one darkfield microscope, or the
ability to convert a brightfield microscope for use as a darkfield microscope.
There is a need for additional darkfield microscopes in areas with greater
prevalence of genital ulcer disease.
Recommendations
Laboratory Direction
The laboratory director should be trained in appropriate
laboratory techniques and safety procedures associated with handling infectious
agents.
The director should have experience in public health and
an understanding of the needs of clinicians and DIS staff.
Optimal qualifications of the laboratory director include
a doctoral degree in medicine or laboratory science (see Appendix ML-A).
The director should ensure that the quality assurance committee's
recommendations for laboratory testing are implemented.
The laboratory director may be on site or at the state or
local health department for laboratories that have the exemption for limited
public health testing.
Staff members should be familiar with work plans and should
receive periodic performance evaluations.
Only personnel who have been advised of potential hazards
and who meet specific requirements should be allowed to enter the laboratory.
The director should ensure adequate staffing to manage the
volume of rapid testing during peak testing hours, lunch, and employee vacations.
Accurate and updated test procedures and biosafety manuals
should be available to all laboratory employees.
Policies should be established to ensure the confidential
storage of laboratory requisitions or log books containing patients' test
results. Confidentiality statutes in each jurisdiction define the records
that are protected from subpoena and may specify the time frame for retention
and the method for destruction.
Laboratory Services
Each clinic that provides STD services should have an on-site
stat laboratory or capacity to perform stat tests. The laboratory must have
a current CLIA certificate and be in compliance with CLIA-88 (see Appendix
ML-A).
At a minimum, stat laboratories should perform the following
tests, all of which are classified as of moderate complexity under CLIA,
with the exception of urine pregnancy tests, which are classified as waived
under CLIA:
Gram stain to detect intracellular gramnegative diplococci
and presence of white blood cells to detect cervicitis or urethritis
nontreponemal antibody card tests for syphilis such as RPR,
TRUST, RST
darkfield examination for Treponema pallidum
saline wet mount for Trichomonas vaginalis and
detection of clue cells of bacterial vaginosis
KOH wet mount for the identification of yeast and for amine
odor (Whiff) test
Urine pregnancy tests
Point-of-care tests should only be used to provide immediate
results and treatment to patients. If testing does not occur immediately,
tests with greater sensitivity and specificity should be used.
The stat laboratory should contain an appropriate number
of brightfield and darkfield microscopes and adequate equipment, supplies,
and reagents to process patient specimens rapidly.
A sufficient number of staff should be trained in darkfield
microscopy to provide coverage during all clinic hours where rapid syphilis
diagnosis is desirable.
The stat laboratory should send the following routine tests
to the state health laboratory or other non-stat laboratory:
presumptive and confirmatory identification and antimicrobial
sensitivity tests for N. gonorrhoeae; [presumptive- moderate
complexity; confirmatory and sensitivity tests-high complexity-CLIA]
chlamydia diagnostic tests (most high complexity-CLIA)
nontreponemal antibody tests for syphilis (VDRL-high complexity,
RPR and other similar card tests-moderate complexity-CLIA )
fluorescent treponemal antibody absorption (FTA-ABS) or
other treponemal tests for syphilis [high complexity-CLIA]; and
HIV antibody tests [moderate complexity-CLIA, many others,
high complexity-CLIA]
Additional stat testing may include;
Tzanck stain for herpes [moderate-CLIA]
spun urine for Gram stain and white cell count [moderate-CLIA]
STD clinics should use routine and reference laboratory services
which further facilitate the diagnosis of STDs.
LABORATORIAN ROLES AND PERFORMANCE STANDARDS
Quality stat laboratory testing by trained personnel contributes
to rapid diagnosis and efficient clinic flow. Laboratory testing is inherently
amenable to objective, continuing methods of quality assurance. Federal regulations
stipulate the professional training needed to conduct laboratory tests. The
employment of personnel failing to meet the professional training requirements
mandated by federal regulations governing diagnostic testing may place persons
and facilities in jeopardy of legal prosecution.
Recommendations
Job qualifications for laboratorians include (at a minimum)
high school graduation and training received at a medical or technical school;
certification as a laboratory technician or technologist, professional registration
as a microbiologist, or a degree in biological science; and, courses in basic
stat laboratory methods for STD testing (brightfield and darkfield microscopy,
gonorrhea culturing, rapid chlamydia tests, and syphilis serology) at one
of the STD Prevention/Training Centers, or similar training.
All laboratory workers should routinely participate in proficiency
testing.
A laboratory worker should possess a professional attitude
and sensitivity about confidentiality; this includes not discussing laboratory
results within patients' hearing.
A laboratory worker should adhere strictly to universal
precautions, safety procedures, and quality control procedures.
LABORATORY BIOSAFETY LEVEL CRITERIA
Biosafety levels consist of combinations of laboratory practices
and techniques, safety equipment, and laboratory facilities appropriate for
the operations performed, the hazard posed by the infectious agents, and for
the laboratory functions or activities. STD stat laboratories fall under Biosafety
Level 2. This means that the laboratory is suitable for work involving agents
of moderate potential hazard to personnel and the environment, laboratory personnel
have specific training in handling pathogenic agents and are directed by competent
scientists, access to the laboratory is limited when work is being conducted,
extreme precautions are taken with contaminated sharp items, and procedures
in which infectious aerosols or splashes may be created are conducted in biological
safety cabinets or other physical containment equipment.
Recommendations
Microbiological Procedures
Access to the laboratory should be limited to appropriate personnel and should be restricted when work with infectious agents is in progress.
Work surfaces should be decontaminated daily, as well as
immediately after a spill.
All infectious waste should be decontaminated before disposal.
Mouth pipetting is prohibited; mechanical pipetting devices
are used.
Eating, drinking, smoking, handling contact lenses, and applying
cosmetics are not permitted in the work areas. Contact lens wearers in laboratories
should also wear goggles or a face shield. Food is stored in cabinets or
refrigerators designated for that purpose only, outside the work area.
Thorough hand washing should be performed after handling
infectious materials and before leaving the laboratory.
Procedures to minimize the creation of splashes or aerosols
should be followed.
An insect and rodent control program should be in effect.
Universal biohazard symbols should be posted on the laboratory
door.
Laboratory personnel should receive appropriate immunizations
or screening for the agent handled or potentially present in the laboratory
(e.g., hepatitis B vaccine or TB skin testing).
Baseline serum samples for laboratory and other at-risk personnel
should be collected and stored, when appropriate, considering the agent(s)
handled. Additional serum specimens may be collected periodically.
A biosafety manual should be prepared or adopted. Personnel
should be advised of special hazards and should be required to read and follow
instructions on practices and procedures.
Contaminated sharp items, including needles and syringes,
should be promptly placed in puncture- proof containers for decontamination.
Laboratory personnel should receive appropriate training
on the potential hazards associated with the work involved, the necessary
precautions to prevent exposures, and exposure evaluation procedures. Personnel
should receive periodic updates, or as necessary.
Cultures, tissues, or specimens of body fluids should be
placed in a container that prevents leakage during collection, handling,
processing, storage, transport, or shipping.
Laboratory equipment and work surfaces should be decontaminated
with an appropriate disinfectant on a routine basis after work with infectious
materials is finished, and especially after spills.
Spills and accidents which result in overt exposures to infectious
materials should be reported to the laboratory director immediately.
Safety Equipment (Primary Barriers)
Biological safety cabinets, or other appropriate protective
equipment should be used when procedures with a potential for creating infectious
aerosols or splash are conducted, or high concentrations or large volumes
of infectious agents are used.
Face protection (goggles, mask, face shield or other splatter
guards) should be used for anticipated splashes or sprays of infectious materials.
Protective laboratory coats, gowns, smocks, or uniforms designated
for lab use should be removed and left in the laboratory before leaving for
non-laboratory areas.
Examination gloves should be worn when handling infectious
materials, contaminated surfaces or equipment. Gloves should be disposed
of when contaminated, or when work with infectious materials is completed.
Disposable gloves should not be washed or reused.
Laboratory Facilities (Secondary Barriers)
Each laboratory should contain a sink for washing hands.
The laboratory should be designed for easy cleaning.
Bench tops should be impervious to water and resistant to
acids, alkalis, organic solvents, and moderate heat.
Furniture in the laboratory should be sturdy, with spaces
between benches, cabinets, and equipment accessible for cleaning.
If the laboratory has windows that open, they should be fitted
with fly screens.
A method for decontamination of infectious or regulated laboratory
wastes should be available (e.g., autoclave, chemical disinfection, incinerator,
or other approved decontamination system).
An eyewash facility should be readily available.
LABORATORY PRACTICE AND TECHNIQUES
Basic stat laboratories should adhere to the recommended practices
and techniques for a Biosafety Level 2 facility. The laboratory should be close
to the examination rooms for easy access by clinicians who are transporting
specimens; however, it should be separated from public areas and general offices
where non-laboratory staff members require frequent access. Each facility should
develop or adopt a biosafety manual. All staff responsible for performing laboratory
testing should adhere to the recommended microbiological practices and follow
approved procedures.
Protocols for transport and storage of specimens should be established
and followed. For example, blood specimens should be delivered to the laboratory
for processing at the earliest practical time, avoiding extended periods in
a car or similar sitting where temperatures may become excessive. If blood
specimens cannot be delivered to the laboratory on the day of collection they
should be stored upright in the refrigerator. Do not freeze, as hemolysis may
occur, ruining the specimen. For chlamydia testing, urine samples should be
transported in an insulated transport container rack to restrict movement and
spillage. Ice packs to maintain a cold atmosphere must be used in the transport
container. If urine samples cannot be delivered to the laboratory on the day
of collection, samples must be frozen and delivered, without being allowed
to thaw, on the next day. Urine specimens stored at room temperature cannot
be used for testing.
Recommendations
Microbiological Practices
All procedures should be consistent with recognized standard
and specialized microbiologic practices.
Biological safety cabinets, previously termed "hood," (Class
I or II) or other physical containment devices should be used during procedures
in which infectious aerosols may be created.
Any activity with the potential for creating aerosols (e.g.,
centrifugation of blood) should be performed in low-traffic areas in the
laboratory.
All testing should be performed under quality assurance guidelines
specific for each test (e.g., control specimens, temperature, time).
Safety equipment should include items for personal protection
such as gloves, coats, face shields, and safety glasses.
Cultures, tissues, or specimens of body fluids should be
placed in a container that prevents leakage during collection, handling,
processing, storage, transport, or shipping. Laboratory specimens should
be placed in durable trays or containers for safe transport, even for short
distances.
Procedures Manual
The manual should include step-by-step descriptions of all methods; modifications of procedures should be initialed by the laboratory director.
The manual should include criteria for laboratory specimen
acceptability.
Daily quality control records pertaining to test controls
and to equipment, temperature, and speed of rotation should be noted in the
manual.
Procedures for quality control checks on new lots of reagents,
whether purchased or prepared, should be noted in a special section.
Instructions for routine tests and special studies should
be documented in the manual.
Biosafety Manual
All new employees should read and understand the biosafety
manual before working in the laboratory. (See section, Standard Precautions,
for OSHA mandated training required for all employees who may have contact
with blood or other body fluids.)
The manual should include information on standard and special
microbiologic practices appropriate to laboratory Biosafety Level 2.
The biosafety manual should be regularly updated.
Laboratory procedures should be reviewed for compliance with
established safety practices by a safety proctor appointed by the laboratory
director.
Centers for Disease Control and Prevention
1600 Clifton Rd, Atlanta, GA
30333, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, 24 Hours/Every Day cdcinfo@cdc.gov
Program Operations Guidelines for STD Prevention
