Laboratory Workshop: Specimen Collection Sean R. Toney Immigrant, Refugee, and Migrant Health Branch Division of Global Migration and Quarantine Centers for Disease Control and Prevention Panel Physician Training Summit March 2017 National Center for Emerging and Zoonotic Infectious Diseases Division of Global Migration and Quarantine

Learning Objectives Identify appropriate sputum collection areas. After this workshop, participants should be able to: Identify appropriate sputum collection areas. Incorporate safety measures and fraud prevention into collection activities. Implement proper sputum collection procedures and Follow requirements outlined in Technical Instructions.

Activity…. This is an interactive activity: Participants will be divide into smaller groups Each group moves to a designated area in the room Each group collectively decides to arrange an indoor, outdoor, or covered outdoor collection area Complete with applicant reception area, waiting area, collection area, and Directly Observed Therapy (DOT) area

Activity…. This is an interactive activity: Each group collectively draws or sketches out the arrangement of the collection area on paper Pros and cons of each groups’ drawing will be discussed Participants will discuss collection processes and procedures Participants will discuss specimen storage and transport

TB Sputum Collection Areas

Specimen Collection Area: Indoor Outdoor “Covered” Outdoor

Specimen Collection Area: OPTIMAL SATISFACTORY ADEQUATE / SUFFICIENT / MINIMAL

Specimen Collection Area: Indoor Requirements Negative pressure in booths Well-maintained ventilation system Adequate air exchange between applicants Booths must allow for direct observation of applicant by technologist TIP: If you are unsure whether negative pressure system is working, put a strip of thin tape or tissue paper at the booth’s window and see if it blows inward.

Sputum Specimen Collection Areas Indoor Source: Panel Sites: Thailand and Ukraine

Sputum Specimen Collection Areas Indoor Source: Panel Sites: Turkey and Malaysia

Specimen Collection Area: Outdoor Requirements Adequate sunlight Good ventilation Collection from multiple applicants Maximum 4 applicants per technologist Minimum of 1.5 meters between applicants

Sputum Specimen Collection Areas Outdoor Source: Panel Sites: Jamaica and Vietnam, and Kenya

Sputum Specimen Collection Areas “Covered” Outdoor Source: Panel Sites: DR and Thailand, and South Africa

Collection Area Considerations: Location Rooftop / Basement Parking lot / Hallway Size Service(s) provided Setup of area Organization Registration Document check Waiting area Bags/Personal Items DOTs area Entrances / Exits Applicant volume Flow of applicants Fraud Prevention Infection Control Ventilation UV lights Sunlight Exhaust Fan(s) Sample storage Sample transport Waste Disposal Job aids (Posters / TV) Supplies Containers Records/Files Paper towels / Napkins Hand Sanitizer Water Wash hands Rinse mouth Collectors Tables Chairs Other…..??

Collection Times

Collection Times Early morning; three (3) consecutive days Mon / Tue / Wed Tue / Wed / Thu Consider transport of specimens, if needed Consider possibility of missed appointments

Safety Measures

Safety Measures Use personal protective equipment (PPE) for: Collecting specimens Processing specimens Inoculating culture tubes PPE includes: N95 or FFP2 respirators Disposable gloves Disposable gowns Dispose of infectious materials Autoclaving Incineration

Safety Measures Use personal protective equipment (PPE) for: Collecting specimens Processing specimens Inoculating culture tubes PPE includes: N95 or FFP2 respirators Disposable gloves Disposable gowns Dispose of infectious materials Autoclaving Incineration

Safety Measures Use personal protective equipment (PPE) for: Staff Applicants / patients New Follow-up DOT PPE for applicants includes: Surgical / face masks

Medical Fraud Prevention Measures

Medical Fraud Prevention Confirm identification Passport Photo Verify signature Specimen collection Supervised Specimen label Side of container Difficult to remove Numbered or bar-coded No names

Sputum Collection Procedures

By show of hands…. How many have collected sputum?

By show of hands…. How many have seen sputum collected?

By show of hands…. How many have regular communication with the lab or specimen collectors?

TB Sputum Specimen Collection

Sputum Collection Sputum must be collected from applicants who have: Signs or symptoms suggestive of TB disease Physical exam suggestive of TB disease Chest x-ray suggestive of TB disease HIV infection Three fasting sputum specimens should be collected from the patient on three consecutive days Important to collect specimens early in the morning IMPORTANT: Sputum specimens must be collected early in the morning on three consecutive days!

Sputum Collection Provide procedure instructions Show applicant how to cough Ensure lid is closed tightly to labeled container Determine suitability of collected specimen Collect at least 5 milliliters Hold up to the light (sun, lamp) to determine if a quality specimen has been collected Reject saliva; recollect Refrigerate specimens if not transported within one hour to decrease culture contamination rate IMPORTANT: Specimen must be sputum, not saliva. Technician will check specimen quantity and quality upon collection. Laboratory must check specimen quantity and quality again upon arrival at lab.

Sputum Collection: Procedure for Applicant No eating prior to sputum collection Clear nasal passages and rinse mouth with distilled water (Do not drink the water) Take several deep breaths Cover mouth with tissue while coughing deeply Deposit sputum specimen in wide-mouthed container

Sputum Collection Container Sterile / unused 10 ml - 50 ml capacity Wide mouth (25mm – 65mm) Screw top Continuous thread

Sputum Specimen Quality Source: Panel Sites: Vietnam and Ukraine, and Fujika 2005

Storage and Transport

Storage and Transport After sputum collected Place upright in transport container Styrofoam cooler / cool box / metal box Gel / ice packs Refrigerator (if batch collection, or delay in transport to lab) Transport to testing laboratory within an hour Hand-carry Courier (motorcycle, bus, etc.) Package Delivery Service Source: Panel Sites: Vietnam, and Pinterest

Applicant Unable to Cough Despite Coaching? Perform Sputum induction Gastric aspiration Bronchoscopy (last resort) Follow infection control precautions during all types of specimen collection IMPORTANT: Follow infection control precautions during all types of specimen collection

Sputum Induction Procedure must be supervised An aerosol of Sterile hypertonic saline (3-15%) is inhaled Saline thins and loosens secretions, irritates airways, and stimulates coughing Applicants are instructed to cough into sterile container Container should be labeled “induced sputum” To prevent rejection by laboratory as saliva Patients with reactive airway disease need pretreatment with a bronchodilator NOTE: Patients with reactive airway disease need pretreatment with a bronchodilator

Gastric Aspiration Technique used to collect gastric content in young children <5 years Inpatient or outpatient procedure Collect 3, over 3 consecutive days Mucus swallowed during night is aspirated first thing in morning using a nasogastric tube Requires immobilization Must neutralize and transport specimen to laboratory immediately TB smears and cultures performed ~25 – 50% of children with active TB will be culture (+)

Gastric Aspiration Curry International Tuberculosis Center http://www.currytbcenter.ucsf.edu/ Free online step-by-step guide to procedure Brief demonstration video clip Steps to Collect GA Other helpful tips List of tools and supplies needed Reading material for parents Source: Curry TB Center

Thank you! cdcQAP@cdc.gov http://www.cdc.gov/panelphysicians For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 Visit: www.cdc.gov | Contact CDC at: 1-800-CDC-INFO or www.cdc.gov/info The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases Division of Global Migration and Quarantine