CDC Immigration Requirements: Technical Instructions for Gonorrhea for Panel Physicians

Please note: October 1, 2016  is the date which panel physicians should have started gonorrhea testing. The Gonorrhea TI were updated on November 23, 2016 which is reflected below.

Preface

The medical screening for gonorrhea among aliens applying for immigrant or refugee status, as well as non-immigrants who are required to have an overseas medical examination, hereafter referred to as applicants, is an essential component of the immigration-related medical evaluation. Because gonorrhea must be appropriately diagnosed and treated, these Technical Instructions provide a method for recording findings from the medical examination and instruct panel physicians in classifying applicants.

The instructions in this document supersede all previous Technical Instructions, Updates to the Technical Instructions, memoranda and letters to panel physicians, and memoranda and letters to international refugee resettlement organizations. These instructions are to be followed for gonorrhea screening and treatment among all applicants and are effective as of November 23rd, 2016.

Visit the Technical Instructions for Panel Physicians webpage for more information about the medical examination for applicants for U.S. immigration.

Key Concepts

All applicants 15 years of age or older must be tested for evidence of gonorrhea.

Applicants younger than the age 15 years must be tested if there is a history of gonorrhea or reason to suspect infection with gonorrhea.

Gonorrhea Screening

Gonorrhea is a sexually transmitted disease caused by Neisseria gonorrhoeae. It is one of the most commonly reported communicable diseases in the United States. Persons with gonorrhea will most often present with urethral or cervical discharge and painful urination. However, it is most often asymptomatic in both men and women, especially if the infection is in the pharynx, cervix, or rectum. Left undetected and untreated in women, gonorrhea may ultimately cause complications such as pelvic inflammatory disease (PID), tubal scarring, ectopic pregnancy, and infertility.

It is important that gonorrhea be correctly diagnosed among applicants applying for U.S. immigration. Correct diagnosis of gonorrhea will ensure that affected applicants receive appropriate treatment, long-term sequelae are minimized, and further spread of the disease is reduced.

Medical History

Obtaining the medical history should include inquiring about any genitourinary symptoms. Men with gonorrhea may report dysuria with penile discharge, while women who are symptomatic may experience vaginal mucopurulent discharge, pelvic pain, or dyspareunia.

Physical Examination

The physical examination must include a search for signs consistent with gonorrhea in applicants ≥15 years of age (and applicants younger than the age of 15 years if there is a history of gonorrhea or reason to suspect infection with gonorrhea).  Other manifestations of gonorrhea that should be evaluated include pharyngeal discharge, rash, ocular symptoms, and abdominal and pelvic tenderness.  However, a genital examination is not required.

Laboratory Testing

A nucleic acid amplification test (NAAT) should be performed for screening.  NAAT allows testing to be performed on specimens such as urine (from men and women), endocervical or vaginal swabs (women), or urethral swabs (men).  Panel physicians should use tests that have regulatory approval in their country, and closely follow the instructions on the product inserts to ensure the correct specimen is used for the laboratory test, as collection methods and specimen types vary.

CDC encourages panel physicians to use the least-invasive test for screening.  Given these options, the least-invasive tests are the urine NAAT (men or women) or self-collected vaginal swab (women).  CDC encourages panel physicians to use these tests.  For self-collected vaginal swab NAAT tests, panel physicians should use test kits that can also indicate if human DNA is present.

In symptomatic men, a Gram stain on urethral secretions, which demonstrates polymorphonuclear leukocytes with intracellular Gram-negative diplococci, can be considered diagnostic. However, a negative Gram stain cannot be used to rule out infection in asymptomatic men. In addition, a Gram stain is not diagnostic on endocervical, pharyngeal, or rectal specimens or in women.

Many gonorrhea tests automatically test for Chlamydia trachomatis. Although chlamydia is not listed in the diseases of public health significance in 42 Code of Federal Regulations (CFR) part 34, panel physicians may use tests kits that screen for both gonorrhea and chlamydia if gonorrhea stand-alone test kits are unavailable; when combined test kits are used, applicants should be informed. Applicants who test positive for chlamydia only should be offered treatment in accordance with the CDC’s Sexually Transmitted Diseases (STD) Treatment Guidelines. If an applicant is tested for chlamydia, the results should be documented in the DS 3026 remarks section (but not under Section 8 where gonorrhea diagnosis and treatment are documented).  If an applicant is diagnosed and treated for chlamydia, this should also be documented in the DS 3026 remarks section (but not under Section 8 where gonorrhea diagnosis and treatment are documented).  Applicants diagnosed and successfully treated for chlamydia should receive a Class B Other classification.

All applicants diagnosed with gonorrhea should be advised to be tested for other STDs, including chlamydia, syphilis, and HIV. The consent for HIV testing should include the following:

• Applicants understand they do not have to be tested for HIV.
• Applicants understand that if they would like to be tested for HIV, they do not have to be tested for HIV by a panel physician.
• Applicants understand that panel physicians must include the test results on the paperwork they complete.

If the applicant consents, panel physicians should perform HIV testing consistent with the standards of care, including pre-test and post-test counseling for the HIV test.

Gonorrhea Screening Results and Travel Clearance

Gonorrhea Treatment

Panel physicians must treat gonorrhea according to CDC’s STD Treatment Guidelines, which are periodically updated, before the medical report form is completed and signed.

Treatment should be provided onsite and be directly observed. Panel physicians should recommend that sex partners of infected applicants also be treated.

Evaluation Post-treatment

A test of cure immediately at the conclusion of therapy is not needed prior to completion of the medical examination following treatment for uncomplicated urogenital or rectal gonorrhea that is treated with any of the recommended or alternative regimens. However, any applicant diagnosed with pharyngeal gonorrhea who is treated with an alternative regimen must have a NAAT or culture test performed 14 days after treatment prior to completion of the medical examination, and the test should be performed by the panel physician. If the NAAT is used and is positive, the applicant should have confirmatory culture with drug-susceptibility testing before re-treatment.

In cases of suspected or documented treatment failure, manifested by symptoms that persist after treatment, panel physicians should perform both culture and drug-susceptibility testing because non-culture tests cannot provide drug-susceptibility results.  Culture requires endocervical swabs (women) or urethral swabs (men).  Additionally, gonococcal cultures require demanding nutritional and environmental growth requirements. Optimal recovery rates are achieved when specimens are inoculated directly and when the growth medium is incubated with an increased CO₂ environment.

Because of a high prevalence of N. gonorrhea infection has been detected among persons previously treated for gonorrhea, all applicants treated for gonorrhea should be counseled that they should be retested 3 months after treatment. However, this post-treatment evaluation does not prevent travel to the United States.

Waivers

A provision allows applicants with a Class A physical disorder to petition for a Class A waiver. The Application for Waiver of Grounds of Inadmissibility Form (I-601 or I-602 for immigrants or refugees, respectively) must be completed. These waivers are submitted to the Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) on an individual basis. The Division of Global Migration and Quarantine (DGMQ) also reviews the waivers and supporting medical examination to provide an opinion regarding the case to the requesting entity (Department of State or DHS, USCIS). DGMQ’s review of the waiver and supporting medical examination documentation is to ensure that the applicant has been classified properly and that an appropriate U.S. healthcare provider is identified for the applicant. DHS, USCIS has the final authority to adjudicate the waiver request.

Documentation

Department of State (DOS) forms Medical Examination for Immigrant or Refugee Applicant (DS-2054), Vaccination Documentation Worksheet (DS-3025), Medical History and Physical Examination Worksheet (DS-3026), and Tuberculosis Worksheet (DS-3030) must be completed in their entirety and included in the applicant’s travel packet. This includes assigning a classification for gonorrhea (Class A or Class B) on the Medical Examination for Immigrant or Refugee Applicant form. Incomplete documentation may result in refusal to grant a visa or designation of medical hold status at arrival to U.S. ports of entry.

For applicants requiring gonorrhea treatment prior to U.S. immigration, the panel physician is required to document the following on the Medical History and Physical Examination Worksheet (DS-3026):

• Laboratory test used to make the diagnosis
• Drug regimen received (including doses, dosage units, and administration routes of all medications), start date, completion date, and any periods of interruption.
• Clinical course observed, such as clinical improvement or lack of improvement during and after treatment, including resolution of symptoms and signs, as well as any drug reactions.

Glossary of Abbreviations

Acronym	Full Phrase
CDC	Centers for Disease Control and Prevention, United States
DGMQ	Division of Global Migration and Quarantine
DHS	Department of Homeland Security
DOS	Department of State
HIV	Human immunodeficiency virus
NAAT	Nucleic acid amplification test
STD	Sexually transmitted disease
USCIS	United States Citizenship and Immigration Services