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Sexually Transmitted Diseases
Sexually Transmitted Diseases  >  Program Guidelines  >  Medical and Laboratory Services

Medical and Laboratory ServicesProgram Operations Guidelines for STD Prevention
Medical and Laboratory Services

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PROVIDING STAT LABORATORY SERVICES IN COMPLIANCE WITH CLIA

The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) are federal minimum quality standards for all laboratory testing. On February 28, 1992, regulations implementing CLIA were published in the Federal Register, Vol. 57, No. 40, February 28, 1992, Rules and Regulations, pp. 7137-7288.

Tables summarizing the personnel requirements for moderate (including Provider Performed Microscopy) and high complexity laboratories are contained in Appendix ML-A, as well as instructions for obtaining a complete list of categorized test systems, a list of waived test systems from the Internet, and a brief history of CLIA. Appendix ML-A also discusses the opportunity for an exemption to the certification requirements for limited public health testing.

Recommendations

  • 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

Venipuncture skills are desired and very often required of STD staff, including Disease Intervention Specialists (DIS). Venipuncture is often performed to obtain a blood specimen for STD/HIV testing. This is a safe procedure when performed correctly by individuals who have received proper training. Training and certification (if necessary) for proficiency in venipuncture is usually obtained by working with a licensed physician or other persons skilled in venipuncture. In many areas the STD staff may perform venipuncture only under a physician's standing order and must adhere to all the stipulations outlined in the standing order. Observation and practice is required to become skilled and self-confident in the art of venipuncture. Several of the STD/HIV Prevention Training Centers (PTCs) offer training in venipuncture techniques. Other opportunities for training include on-the-job, one-on-one training in a clinical practicum with a health care worker properly qualified to train and certify (if necessary), or local private providers who can be contractors (e.g., Red Cross, blood banks, community colleges). The training provider may be a city or county clinic or health department, state health department, local hospital, school of medical technology in a college or university, or a Red Cross training program. A sample training program is included in Appendix ML-F.

When performing venipuncture, the STD staff should always be aware that this procedure is being done under the legal authority of the local health officer. The staff must become familiar with the relevant legal authorities and adhere to the procedural requirements of the health department Laboratory Director. It is imperative that the staff exercise the utmost care and professional judgment in the application of venipuncture procedures. If a needle-stick injury occurs, the injured employee should immediately contact their supervisor and follow local health care worker occupational exposure policies (see section on emergency procedures). In addition, for Federal employees, immediate notification of the exposure should be provided to the CDC Office of Health and Safety.

Venipuncture in the field (field bloods) is most commonly performed by DIS on members of identified groups at high risk of syphilis and HIV infection; partners of known syphilis or HIV positive patients; associates of known syphilis patients (including cluster suspects); and previously examined persons for whom a physician desires another serologic test only. Each program area should determine their priorities for field bloods.

Professional judgment may compel the DIS to draw a blood specimen from an individual who clearly is in need of clinical evaluation or treatment. It would be prudent for the DIS to extract a specimen when the opportunity presents itself, if it appears the individual is deemed unreliable or expresses reluctance to accept medical services. Such applications of field venipuncture must be considered judiciously and in context with local policies. When these situations arise, the DIS must report such activities to the supervisor at the earliest opportunity.

Recommendations

  • 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 MLF 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

The work performed by disease intervention specialists (DIS) is essential to the successful operation of a STD clinic. DIS reinforce the education and counseling messages provided by the STD clinician during the examination. More importantly, they interview and counsel patients and perform investigations to locate people who may be at risk for STD and refer them for examination, treatment, and counseling (see the chapter on partner services for more detail on DIS activities outside the clinic). It is appropriate for the DIS to offer a full range of intervention services in a single session rather than ask a patient to repeat the same information to several people. Because STD-related information is sensitive, the patient's transition between clinical care and the STD interview or HIV prevention counseling session must be smooth and appear to be natural extensions of each other.

Recommendations

  • 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

Quality assurance activities and programs within clinics are important functions that ensure a minimal standard of acceptable clinical care, clinic management, and clinic operations. A well designed quality assurance program provides opportunity for clinic personnel from diverse areas to interact in the process of objectively reviewing clinical, management, and operations outcomes. The results of quality assurance activities should be used to modify clinic policy and procedures in an effort to improve clinical care, clinic management, and/or clinic operations.

Recommendations

  • 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

Morbidity

Epidemiologic surveillance is the continuing and systematic collection, analysis, and interpretation of health data in the process of describing and monitoring a health event. Surveillance reporting permits a program to fulfill its mandated function of informing the public about a health problem, and facilitates basic program planning, implementation, and evaluation to determine public health action. State law specifies which diseases to report and which practitioner or facility is responsible for reporting diseases and situations (e.g., child abuse) to the official state agency. Reportable STDs mandated by state laws and included in federal and other voluntary surveillance systems usually include cases of gonorrhea, chlamydia, syphilis, chancroid, lymphogranuloma venereum, and granuloma inguinale. Some states also require reporting of HIV, PID, or genital herpes. Uniform STD surveillance case definitions are vital to the management of disease prevention programs. Case definitions may differ from diagnostic criteria meant to assist the clinician in arriving at a certainty of diagnosis for a given patient and disease. (See Surveillance and Data Management for further information.)

Sexual Abuse and Assault

The management of STDs in children and the suspected sexual abuse of children requires close cooperation between clinic personnel and child protection authorities. Some diseases, such as gonorrhea and syphilis are virtually 100% indicative of sexual contact if diagnosed in children after the neonatal period. The association of other STDs in children and the occurrence of child sexual abuse is not definitive. Most STD clinic personnel lack experience in the management of suspected child sexual abuse evaluations. Suspected victims of child sexual assault or abuse should be examined by a provider trained and/or certified to do such evaluations. Alternatively, suspected victims can be referred to an Emergency Department where trained clinicians are on call 24 hours/day. Clinic protocols should address referral policy and clinic staff should facilitate a referral, if necessary, in a manner that minimizes the victim's discomfort and anxiety.

Domestic Violence

The US Department of Justice estimates that 55% of women are raped and/or physically assaulted during their lifetime.(U.S. Department of Justice, 1998) Overall, estimates of numbers of women who experience abuse annually in the United States range from 8 to 12 percent. (Wilt, 1996) Many believe that these estimates are low. Victims and their abusers, more often than not, know each other and frequently live in the same household. The term domestic violence generally refers to violence and abuse within the home but also includes violence and/or abuse between people who know each other regardless of where the abusive event(s) takes place. Physical violence and abuse is only one method that an abuser may utilize to maintain control over the victim. Other abuse tactics include emotional and verbal abuse, isolation, and threats and intimidation. (U. S. Department of Justice, Website) Risk factors for domestic violence and abuse, such as young age, and drug and alcohol abuse are frequently the same as those for having a STD. This suggests, at least, that screening for domestic violence and abuse in venues where there is screening and treatment for STDs would lead to the identification of intervention opportunities for what is a universal health care problem.

The federal Violence Against Women Act, passed as part of the Violent Crime Control Law Enforcement Act of 1994, established the National Domestic Violence Hotline. This nationwide, toll free hotline serves victims of domestic violence by providing local referral information. The hotline can be reached by dialing 1-800-799-SAFE or 1- 800-787-3224 (TDD).

A Community Checklist: Important Steps to End Violence Against Women, (Department of Justice, 1995) identified several strategies that health care professionals can employ to intervene effectively into the problem of domestic violence in their communities and amongst their clients. These include:

  • Incorporate Training into Curricula
  • Make Resources Available to Patients
  • Support Incorporation of Protocols into Accreditation Process
  • Encourage Continuing Education on Violence Against Women Issues
  • Involve Medical Organizations and Societies in Increasing Awareness
  • Feature Violence Against Women on Meeting Agendas
  • Highlight Commitment to Violence Against Women Issues
  • Develop a Standard Intake Form
  • Ensure Employee Assistance Programs are Responsive to Victims of Domestic Violence
  • Volunteer in Community Organizations That Serve Victims of Domestic and Sexual Violence

Recommendations

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.

SCREENING

Because many sexually-transmitted diseases are asymptomatic, seeking care when symptoms occur is unlikely to lead to detection of most infections. Therefore, screening is critical for early detection and treatment. Although persons with STDs may not specifically seek infection-related treatment services, they do visit several health care settings for other purposes. These visits are an opportunity to diagnose and treat STDs. Examples of healthcare settings in which this screening can take place are family planning clinics, prenatal clinics, emergency rooms and walk-in clinics, community and migrant-worker health centers, clinics for adolescents, school-based clinics, clinics in correctional facilities, and primary-care provider offices.

Screening criteria have been defined in national guidelines. But, in the absence of well-defined screening criteria, prevalence of infections should be assessed in clinical settings that serve people who are potentially at risk. In populations where the prevalence is high (i.e., >2%), routine screening should be implemented. Previously described examples of populations at risk are people who abuse illicit drugs, who have more than one sex partner per year, who are entering correctional facilities, and who live in communities with high rates of STDs. Determination of risk should also take into account the prevalence of HIV infection in the population being considered.

Early detection and treatment of STDs among HIV-infected persons can be effective and cost-beneficial in reducing HIV transmission for three reasons: most STDs promote increased shedding of HIV (Cohen, 1997); the number of HIV-infected persons is smaller than the number of persons at risk for becoming infected; and HIV-infected persons often receive regular medical care. All HIV-infected persons who are having unprotected sex should be screened for other sexually-transmitted infections, including gonorrhea, chlamydial infection, syphilis, and trichomoniasis. Persons with HIV/AIDS should be assessed for genital herpes, informed about the symptoms of herpes, and counseled particularly to avoid sex during periods with symptoms of reactivation of genital herpes, which are associated with higher rates of HIV viral shedding (Schacker, 1998). Sexually active, HIV-infected persons should be screened annually. If the person's risk behavior, risk behavior of the person's partner(s), and the incidence of STDs in the local population place the HIV-infected person at greater risk for another sexually-transmitted infection, screening should occur more frequently.

Guidelines for screening for the major sexually transmitted pathogens and for screening specific population groups (e.g., adolescents) have been recently published (U.S. Preventive Task Force, 1996; American Medical Association, 1992). The Advisory Committee for HIV and STD Prevention endorses these existing screening guidelines and extends them to include the following recommendations:

  • All sexually active females less than 25 years old who visit a health care provider for any reason should be screened for chlamydia and gonorrhea at least once per year, unless screening in that setting has been documented to yield a low prevalence of infection (i.e., <2% using sensitive tests).
  • All young, sexually active men should be screened routinely for chlamydial and gonococcal infections in an acceptable fashion which may include using urine as a specimen for screening.
  • Older males and females at risk because of their behavior should be screened for chlamydial infection and gonorrhea at least once per year when visiting health care providers for any reason.
  • Serologic screening for syphilis should be conducted in all persons at risk (e.g., persons who exchange sex for money or drugs, persons with multiple sex partners or partners who have exchanged sex for money or drugs, persons admitted to jails, and users of illicit drugs).
  • Sexually active, HIV-infected persons should be screened at least annually for STDs.




Page last modified: August 16, 2007
Page last reviewed: August 16, 2007 Historical Document

Content Source: Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention