The clinic facility must be physically accessible in accordance with the Americans with Disabilities Act.
Clinics should be located so
that they are readily accessible through public and private transportation
from residential areas.
The general public should be
able to easily determine how to obtain specialized STD services.
Clinic hours and staffing should
be sufficient to accommodate patients, with minimal patients turned away.
A system to periodically assess
clinic user (or patient) satisfaction with services should be in place.
No patient should be denied care
for lack of money. Medical services should be at no charge, minimal, or based
on a sliding scale.
Fees should not be assessed
for examining persons referred by a disease intervention specialist.
RANGE OF SERVICES (ML-2)
At a minimum, clinics should have the capability to accurately diagnose and treat bacterial STDs.
Clinics should have the capacity
to distribute medications for diseases diagnosed in the clinic. At a minimum,
medications must be available for locally prevalent STDs, with prescriptions
available for diagnosed diseases not prevalent in the community.
Clinics should provide condoms
and counseling on primary prevention to all patients.
Clinics providing Pap smears
should have specific protocols for follow-up of abnormal results that include
guidelines for colposcopy referral.
Clinics providing pregnancy
tests should have specific protocols for follow-up and referral of positive
tests.
Clinics should collaborate with
immunization programs and viral hepatitis programs to provide hepatitis B
vaccinations to those at risk.
Clinics should provide the basic
range of HIV related services specified in state and federal statutes and,
for patient convenience, should offer as many as possible on site (e.g.,
counseling and testing, partner services).
Confidential counseling and testing
for HIV should be offered at the time of the STD visit so that patients do
not have to visit separate clinics or make return visits.
Confidential counseling and
testing for STDs, including HIV, should not be denied because a patient refuses
other STD services.
Anonymous HIV testing should
be available on site for patients requesting the service or at community
sites convenient to patients.
Written policy and procedures
should be in place for the referral of patients for HIV early intervention
services (e.g., continuing medical evaluation, tuberculosis and immune system
testing, treatment, and support group counseling).
When not offered on site, the
mechanisms for referral should be established for relevant health services
(e.g., family planning, prenatal, adult immunizations, drug counseling).
CLINIC ENVIRONMENT (ML-3)
Facility
The building in which a STD clinic is located should have signs making it easy to locate. Signs at the building entrance should be easy to read and should clearly list STD among the services.
Waiting areas should contain
accessible patient education (i.e., handouts, posters, pamphlets, or audiovisuals)
that emphasize risk reduction behaviors for the prevention of STDs, HIV,
and viral hepatitis.
Examination rooms should be clean
and private and should have adequate equipment and supplies for physical
examinations and specimen collection for both male and female patients.
The number of examination rooms
should be adequate to accommodate the number of clinicians (at least one
room per clinician) and to serve patients promptly during the normal working
day.
Patient Considerations
Patient confidentiality must be maintained. Confidentiality should be promoted by using a system other than names when calling patients from waiting areas.
Clinic personnel should be courteous
and respectful of patients.
Patients should be told what
to expect during the clinic visit, including being told STDs for which they
are being tested and the common ones for which they are not being tested.
All clinic staff should develop
and maintain cross-cultural awareness and display cultural sensitivity.
An adequate portion of the clinic
staff should have bilingual fluency that facilitates services to those patients
who do not speak English.
Clinics should assess the need
for physical security during clinic sessions and have security protocols
in place.
REGISTRATION PROCESS (ML-3)
Confidentiality
Registration information should
be obtained in a confidential manner.
Acoustical barriers separating
clerks from waiting areas in addition to methods of self registration should
be considered when distance does not prevent persons from overhearing those
who are registering.
Information collected at the
registration desk should be relevant: locating and demographic data, type
of visit (referral, appointment, or walk-in); clerks should avoid discussing
the medical reason for the visit including any symptoms or medical history.
Patient address should be verified
at every visit in the event that follow up is needed.
Procedure
Telephone reports of test results must follow clinic procedures to ensure confidentiality.
Clinics should have systems in
place to assess and modify patient visits to assure minimal waiting.
The "expected-in" file
should be checked for every person at every visit as part of the registration
process.
Priority patients should be given
preferential service.
CLINIC FLOW (ML-4)
Appointment and Walk-in
Systems
The responsibilities of the clinician will play a role in determining the number needed in a clinic.
Walk-in patients with genital
ulcers, discharges, and women with abdominal pain or who are pregnant should
be examined that day.
Patients referred by DIS should
be seen on a priority basis on the same day.
Walk-in patients who are not
examined within the day should be given a list of STD medical resources and
eligibility requirements (e.g., urgent care clinics, family planning clinics,
private physicians) and encouraged to call for a next-session appointment.
Clinic Flow
Clinic flow should be designed
so that the next available clinician sees the next patient registered. An
exception may be made where local medical practice standards or legislation
stipulates gender requirements. Patients who request a clinician of a specific
sex should be accommodated whenever possible.
Patient stops should be kept
to a minimum (ideally, not more than three-registration, clinical care, and
an STD/HIV interviewing/counseling session, if needed).
Patient flow analysis should
be conducted periodically to provide a systematic understanding of where
bottlenecks in clinic flow occur.
MEDICAL RECORDS (ML-5)
Medical records should contain sufficient demographic information to contact the patient and sufficient clinical evaluation information to readily interpret the examining clinician's assessment and clinical findings.
All procedures concerning content
and filing of medical records should be in accordance with state and local
laws and statutes.
STD programs should follow written
procedures for the management of medical records that includes forms management,
organization of the medical record, records security, and adherence to statutes
for record retention.
An individual should be assigned
the responsibility of managing the release of records due to subpoena, court
order, etc. This person should track all matters relating to request to view
medical records.
CLINIC MANAGEMENT STRUCTURE (ML-6)
The clinic manager should have adequate specialized training in STD, clinic and personnel management, and public health.
The medical director should have
specialized training in STD, be available for consultation during clinic
hours and ensure the overall quality of clinical services.
CLINIC MANUALS (ML-7)
Personnel Policies
An STD clinic manual should contain the goals and the objectives of the clinic, including fully integrated STD/HIV services.
Job descriptions and performance
standards should be provided for all staff members. These descriptions and
standards should include:
qualifications and training requirements for each job;
the role each job plays in the
operation of the clinic;
a description of the essential
tasks required for each job;
the mechanism for performance
evaluation; and,
attitudes expected to be conveyed
to clinic patients.
Policies regarding employee health
(e.g., injury surveillance, HIV exposure, tuberculosis screening, and hepatitis
B vaccination) should be consistent with state and local employee health
regulations and should be clearly written and enforced.
Procedures for formal quality
assurance should be provided.
Local policies and procedures
included in the manual (frequency of staff meetings, fire drill instructions,
sick leave, and vacation) should be current.
Medical Protocols
Clinic protocols or standard medical instructions for specific patient management should include:
patient evaluation;
management of STDs (See CDC
STD Treatment Guidelines);
medical consultation and referral;
follow-up after therapy;
counseling/education;
and management of sex partners.
Protocols should include current
recommended treatments for STDs.
Emergency medical protocols should
be current.
Protocols for the safe handling
of blood and body fluids (standard precautions) should be current and practical
for most clinic situations.
Current and signed standing
orders for non-physician clinicians should be included if required or not
prohibited by state laws and regulations (medical practice acts).
CLINICIAN ROLES AND PERFORMANCE STANDARDS (ML-8)
Nurses, nurse practitioners, and physician assistants should work in full compliance with established
clinic protocols as clinicians responsible for the entire clinical care process,
including history taking, physical examination, laboratory specimen collection,
diagnosis, treatment, plan for follow-up, and counseling/education.
Non-physician clinicians should
have adequate physician backup and specific standing orders.
All clinicians should have a
specific STD training course and AIDS update course.
STANDARD PRECAUTIONS (ML-8)
Standard Precautions should be
applied to (1) blood; (2) all body fluids, secretions, and excretions, except
sweat, regardless of whether or not they contain visible blood; (3) broken
skin; and, (4) mucous membranes. Standard Precautions are designed to reduce
the risk of transmission of microorganisms from both recognized and unrecognized
sources of infection in health care settings.
Protective barriers should be
appropriate and available for the type of exposure anticipated and may include
latex or vinyl examination gloves, gowns, masks, and protective eye wear.
Needles and syringes should
not be recapped or removed from disposable syringes.
Disposable syringes and other
sharp items should be placed in puncture-resistant containers located in
the immediate vicinity where venipuncture procedures take place.
Gloves should be worn during
venipuncture to reduce the incidence of blood contamination, recognizing
that they cannot prevent needle-stick injuries.
Clinicians and phlebotomists
should change gloves between patients.
Gloves should not be worn outside
the examination room or the laboratory.
Skin on hands or other parts
of the body should be immediately and thoroughly washed if contaminated with
blood or other body fluids. Hands should always be washed before and after
the examination and before leaving the examination room.
Infectious waste should be incinerated
or autoclaved before disposal in a sanitary landfill.
A surveillance system should
be established for injuries such as needle-sticks, percutaneous injuries,
and mucous membrane contamination; protocols should specify collection of
confidential information about the worker and about the source individual
(if applicable and possible), and about the cause and type of injury, medical
treatment, counseling, and follow-up.
EMERGENCY PROCEDURES (ML-10)
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 (ML-10)
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 gram-negative 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 nonstat
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 (ML-12)
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 (ML-13)
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 punctureproof 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 (ML-14)
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.
PROVIDING STAT LABORATORY SERVICES IN COMPLIANCE WITH CLIA (ML-15)
The exemption to the certification
requirement for each location available for limited public health testing
(LPHT) should be pursued, if feasible. The state public health laboratories
may be the only facilities with the mandate, expertise, and infrastructure
to facilitate laboratory partnerships between large numbers of locally administered
clinic laboratories.
VENIPUNCTURE (ML-16)
A continuing
Quality Assurance program should be in place to monitor the venipuncture
performance of STD staff.
The DIS supervisor should closely
monitor DIS until assured that their venipuncture performance is satisfactory.
Periodic monitoring should continue
after the initial observation period. See Appendix ML-F for an example of
a venipuncture evaluation tool.
When labeling and transporting
specimens, the DIS should:
Print the patient's name and date of birth (if known) or place a pre-printed label on the specimen tube
after the blood has been collected. Include the date the specimen was drawn. To prevent the incorrect labeling of blood specimens do not pre-label blood collection tubes.
Maintain blood specimens in an upright position with the stopper at the top, either by placing in a specimen rack or in a cardboard container. Pack the containers tightly so the specimens will be secure in transit.
Blood specimens should be delivered to the laboratory for processing at the earliest practical time. Avoid leaving for extended periods in a car or similar place where temperatures may become excessively high or low. Also, make sure specimens remain in your care and that they are not handled by unauthorized persons.
When blood specimens cannot be delivered to the laboratory on the day of collection, make sure they are stored upright in a refrigerator. Do not freeze, as hemolysis may occur, ruining the specimen.
DISEASE INTERVENTION SPECIALIST SERVICES IN MEDICAL FACILITIES (ML-17)
Consistent prevention messages to patients should be facilitated through regular communication between clinic providers and DIS.
Clinic procedures should promote
a smooth and confidential exchange of relevant disease intervention information
between clinical staff and DIS.
DIS should be on site or on
call to provide disease intervention services during clinic hours. Where
resources are lacking for specialized disease intervention staff, or work
is reassigned based on disease priorities, clinicians and counselors can
perform intervention services.
DIS should have a thorough understanding
of STD clinical care and STD diagnostic test results.
Clinic protocols should specify
which patients are to receive STD and HIV intervention services from DIS.
DIS should be provided with an
adequate number of private rooms to ensure that confidential STD interviews
and HIV prevention counseling sessions can be conducted without interruption.
All personnel should be evaluated
for STD intervention and HIV test counseling skills to assure consistency
of messages.
QUALITY ASSURANCE PROCEDURES (ML-18)
A quality assurance committee should meet regularly and follow an approved protocol to conduct audits, analyze findings, and deliver recommendations.
Medical records should be audited
regularly (checked against clinic protocols) to determine the appropriateness
of diagnoses and treatment and the completeness of documentation.
The quality of stat laboratory
procedures should be monitored regularly.
Staff interactions with patients
should be observed regularly.
Semiannual safety audits should
be performed to determine the appropriate use of electrical equipment, storage
of chemicals, emergency procedures, and first-aid stations.
A mechanism should be established
for receiving, reviewing, and responding to complaints of patients.
Representatives of the finance
office and data processing unit should also be included on the quality assurance
committee so that they can gain and maintain an understanding of clinic operational
needs.
REPORTING (ML-18)
Disease Morbidity
Clinics should promptly submit morbidity reports following the diagnosis of a case in the format determined by the state or local prevention program.
Morbidity reports should be complete,
legible, and checked for accuracy before submission.
The quality assurance of morbidity
reports should involve periodic comparison with medical records.
Computerized medical record systems
should be linked to electronic morbidity reporting to expedite rapid data
collection.
Clinic reporting systems should
have the necessary safeguards to ensure the proper and nonduplicative reporting
of laboratory results and diagnostic determinations.
Sexual Assault and Abuse
All clinic staff should be familiar with provisions of the state child abuse and neglect statute and their obligations under it.
Clinic staff members should be
familiar with applicable STD and HIV confidentiality statutes and should
be sensitive to any limitations on the reporting of supplementary information
about suspected abuse cases.
The clinic manual should specify
the management of patients of alleged abuse, listing the required examination
and proper handling of laboratory specimens for evidence, and reporting procedures.
Testing of abused or assaulted
patients should be performed using the most specific tests available.
Clinics should set up a mechanism
for referrals to perform additional confirmatory testing necessary to make
a definite diagnosis.
Clinics should have a patient
advocate who maintains links with victim's assistance programs.
Domestic Violence
All clinic staff members should be familiar with domestic violence statutes.
STD programs should incorporate
domestic violence issues into their staff training.
MEDICAL AND LABORATORY SERVICES APPENDICES
ML-A CLIA (ML-22)
ML-B COMMONLY USED STAT
TESTS: SALINE AND 10% KOH WET MOUNTS, VAGINAL PH (ML-26)
COMMONLY USED STAT TESTS:
GRAM STAIN FOR MICROORGANISMS (ML-28)
COMMONLY USED STAT TESTS:
EXAMINATION OF SPECIMENS BY DARKFIELD MICROSCOPY (ML-30)
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
