Tuberculosis in SA today as a Healthcare Challenge

Breathe Easy. Worry Less.

7/5/2013

National Core Standards for Health Establishments in South Africa

The main purpose of the National Core Standards is to:

Develop a common definition of quality care which should be found in all

health establishments in South Africa, as a guide to the public and to

managers and staff at all levels;

Establish a benchmark against which health establishments can be

assessed, gaps identified and strengths appraised; and

Provide for the national certification of compliance of health establishments

with mandatory standards

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National Core Standards for Health Establishments in South Africa 2011

Domain 2: Patient Safety, Clinical Governance and Clinical Care

Sub-domain

2.6 Infection prevention and control

Standard 2.6.2

Specific precautions are taken to prevent the spread of

respiratory infections

Criteria 2.6.2.1

A programme for the prevention and control of respiratory

infections is in place (eg for tuberculosis)

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Definitions

MDR TB (multidrug resistance)

Where there is resistance to both INH and Rifampacin

XDR TB (extreme or extensively drug resistant TB)

Where there is resistance to INH and Rifampacin as well as any fluroquinalone in addition to one of the injectable TB agents (kanamycin and amikacin and capreomycin) (but excluding streptomycin)

TDR (Totally Drug Resistant):

Resistant to > 9 drugs in the absence of clinical response

Mono-resistance

Resistance to one of the first line TB drugs. Poly-resistance

Resistance to more than one first line TB drug. (but not both INH and RIF)

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When is the HCW (Health Care Worker) at risk? 1. High risk

Prolonged close contact with infectious

( smear positive)

Aerosol producing procedures

HCW with HIV+ who are involved in regular TB pts management.

2. Medium risk

Sputum collection

Prolonged closed contact with retreatment pts

3. Low risk

HCW in PHC(primary health centre) centre's involved in management of TB pts

Porters, cleaners, administrative staffs

HCW in general hospitals & community health centre's.

Environmental Factors Increase Risk for Transmission

Exposure in small, enclosed spaces

Inadequate ventilation

Recirculated air containing infectious droplets

Inadequate cleaning and disinfection of equipment

Improper specimen-handling procedures

Treatment

Goals

To cure the individual patient

Minimize the transmission of Mycobacterium tuberculosis to other persons

Directly observed therapy (DOT)

Assure adherence.

DOT involves the provision of anti-tuberculosis drugs directly to the patient and watching him/her swallow the medication

Drug Cost – 30 days - Cost per patient per month) 2008 2009 2010 2012

PAS (4g BD) R1600 R 2360 R2358

Capreomycin (1g 5x) R800 R 1300 R2391

Moxifloxacin (400mg OD) R 800 R911

Terizidone (250mg tds) R650 R 579 R566

Cycloserine (250mg tds) R600 R 522 R522

Klacid (500mg BD) R 228 R123

Amikacin (1g 5x) R400 R 216 R223

Kanamycin (1g 5x) R250 R 200 R239

Clofazamine (300mg) OD R204

Ethionamide (250mg tds) R130 R 177 R191

Ofloxacin (800mg OD) R60 R 54 R349 (R135)

Augmentin (625mgs BD) R 112 R74

Rifafour (4 BD) R80 R 67 R67

PZA (1,5gm OD) R50 R 42 R33

Rifanah (300 – 2 BD) R 40 R42

EMB (1,2 OD) R 38 R43

Ciprobay (1,5gm) OD R36 R 32 R36

Drug Costs

Drug (> 50KG) Cost (per patient per month)

2010

STD TB (intensive phase) R67

STD TB (continuation phase) R42

MDR (intensive phase) R1207

MDR (continuation phase) R968

XDR (intensive phase) R6654

XDR (continuation phase) R4263

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You may have the newest or best facility, structurally but if appropriate infection control measures and mechanisms are not in place you are failing staff and patients

Infection Control is the KEY

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Fundamentals of Infection Control

Respiratory Protection

Administrative Controls

Environmental Controls

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Way Forward

Administrative Measures – must be introduced in all facilities

Reduce risk of exposure via effective IC program

Infection control teams & policies

Triaging of Patients

Training of staff

Environmental Measures (Prevent spread and reduce concentration of droplet

nuclei)

New Hospitals, clinics and waiting areas built must be designed to provide

good ventilation & infection control.

Existing facilities must be reviewed and revitalized to facilitate ventilation &

infection control

Possible interventions

UV lights – if affordable

Fans (extractor + Normal)

Mechanical ventilation systems

Create new windows to improve natural ventilation

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Our responsibility to infection control

We need to reduce exposure of staff, patients and visitors to TB

We need to ensure necessary measures are in place

Have proper infection control guidelines in place

Implement these guideline

Educate everyone

Assess facility for problems

Do formal risk assessments

Implement triaging of patients

Improve ventilation

Implement air exchange assessment

Implement fit testing

Have personal protection available

Have regular staff wellness monitoring

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Infection Control Program

Patient education

Cough hygiene (turn head/cover mouth)

Surgical masks – are used on patients coughing excessively or during transport.

Isolation of Patients

Isolation of TB from MDR from XDR patients (in ideal circumstances)

Good ventilation

Natural ventilation (open window policy) in multi-storey

Mechanical Ventilation - Negative pressure ventilation

Individual Protection - N95 respirators

Respirators – (filter small enough to stop TB / need tight fit).

Implemented fit testing.

Ultraviolet lights

Require proper maintenance and monitoring

Cost implication

Certain risk to staff

Respiratory Protection Controls

Reduce the risk of exposure

Implement Respiratory Protection program

Train HCWs in RP

Respirator masks

Correct donning

Correct removal

Correct disposal

Train patients in respiratory hygiene

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Respiratory Protection Controls

Personal protection for staff

Personal particulate respirators (N95 or FFP 2

masks) are very different than surgical masks.

Protects the wearer of from Airborne particles

that are 1 – 5 µm in diameter

Surgical mask not effective to prevent TB

transmission.

Can be worn continuously for 8 hours.

N95 masks are single use only, discard into

medical waste directly after removal,

decontaminate hands.

Make sure of mask fit

What is a surgical N95 respirator ?

A surgical N95 respirator is a NIOSH-approved N95 respirator that has also been

cleared by the Food and Drug Administration (FDA) as a surgical mask

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Who is NIOSH?

The National Institute for Occupational Safety and Health (NIOSH) is the U.S.

Government agency responsible for the certification and approval of respiratory

protective devices for occupational use.

Who is the FDA?

The Food and Drug Administration (FDA) is the U.S. Government agency that

oversees most medical products, foods, and cosmetics. This includes surgical

masks and surgical N95 respirators

Oil resistance Rating Description

Not oil resistant N95 Filters at least 95% of airborne particles

N99 Filters at least 99% of airborne particles

N100 Filters at least 99.97% of airborne particles

Oil Resistant R95 Filters at least 95% of airborne particles

R99* Filters at least 99% of airborne particles

R100* Filters at least 99.97% of airborne particles

Oil Proof P95 Filters at least 95% of airborne particles

P99 Filters at least 99% of airborne particles

P100 Filters at least 99.97% of airborne particles

NIOSH Standards

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If a particulate filtering face piece respirator does not have these markings as identified above and does not appear on one of the NIOSH lists, it has not been certified by NIOSH for occupational use.

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Reference: Rengasamy,S.,W.P.King, B.C.Eimer and R.E. Shaffer.(2008). Filtration performance of NIOSH-approved N95 and P100 filtering facepiece

respirators against 4 to 30 nanometer-size nanoparticles. Journal of Occupational and Environmental Hygiene 5(9):556-564

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TC# xxx-xxxx Approval number

Model # xxxx

Lot # xxxxx

Filter designation: NIOSH filter series ie N95

The name NIOSH or the logo

Approval holder’s business name or manufacturers business name

European Standards EN 149:2001

Class Filter penetration limit (at 95 L/min air flow) Inward leakage

FFP1 Filters at least 80% of airborne particles <22%

FFP2 Filters at least 94% of airborne particles <8%

FFP3 Filters at least 99% of airborne particles <2%

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All Kimberly-Clark Face Masks meet or significantly exceed the EN 14683 norm

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Test Type I Type IR Type II Type IIR

Bacterial Filtration

Efficiency (BFE) % ≥ 95 ≥ 98

Differential Pressure (Pa) < 29,4 < 49,0 < 29,4 < 49,0

Splash Resistance (mm Hg) n/a ≥ 120 n/a ≥ 120

NOTE: Type IR and IIR are splash resistant

KIMBERLY-CLARK* FLUIDSHIELD* 160mmHg

LONCET* Polyethylene- Film

So which respirator???

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How do I know what size I need?

Fit testing is needed to determine if a particular size and model of

respirator provides you with an acceptable fit.

Fit testing is model specific.

Before you wear a respirator in an occupational setting, you must

be fit tested in each respirator model you will wear

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N 95 PFR Mask

N95 masks are made up of 5 layers:

• Inner layer

• Fluid resistant Layer

• Filter media x2

• Outer facing

Ultra-sonically bonded:

This process is called Sontec II and bonds the different layers together to give added strength.

Wet-Lay process of the Inner facing:

The wet-lay process was designed to enhance fibre pin down. It utilizes a water spray and a vacuum system to help each fibre to lay down against the material as opposed to fraying up and falling off of the material. The benefit of this is comfort and less irritation due to clinging to facial hairs.

Construction of Kimberly-Clark face masks:

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Construction (continued)

Fully enclosed 100% aluminium nose piece

• Prevents glare and improves lack of blow-by

Material composition:

• Non-woven materials

• Latex and glass free

On PFR masks:

Polyester cellulose/Meltblown polypropylene/Loncet layer/polyester cellulose.

Duckbill design

• Larger breathing chamber

Double Elastic head bands

• To ensure secure fit to prevent blow-by

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Fluid Resistance

LONCET FILM

A B C D

A - INNER

B - LONCET

C - FILTER

D - OUTER

More blood resistant (160mmHg)

Breathable (micro- perforated)

Patented Film (false copies)

Blood

Air Air

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AIR

OUT

AIR

IN

BLOOD BLOOD

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PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK

Pouch style orange face mask with headbands (patented colour)

Catalogue Number:

PFR95 Particulate Filter Respirator and Surgical Mask.

Regular Size

Performance Data:

Sub-micron Particle Filtration Efficiency (0.1 micron): 99.7%¹

Differential Pressure (Breathability): 5.0mm H2O/cm²

Bacterial Filtration Efficiency (BFE in vitro, 2.8 micron): >99.9%²

Bacterial Filtration Efficiency (BFE in vivo, 4.6 micron): 99.9%³

Composition:

Polypropylene, Polyester, Polyethylene, Polyurethane, Aluminium (nose wire)

LONCET LAYER - PATENTED layer

Notes:

NIOSH Approved N95 Particulate Respirator

Used as part of PPE for TB patients.

Natural Latex Free, Non-sterile, Single use only

Separate the edges of the

respirator to fully open it.

Slightly bend the nose wire

to form a gentle curve.

Hold the respirator upside

down to expose the two

headbands.

Instruction for use

Fit Testing

Using your index fingers

and thumbs, separate the

two headbands.

Instruction for use

Fit Testing

While holding the headbands

with your index fingers and

thumbs, cup the respirator

under your chin.

Instruction for use

Fit Testing

Pull the headbands up

over your head.

Instruction for use

Fit Testing

Release the lower

headband from your

thumbs and position it at

the base of your neck.

Instruction for use

Fit Testing

Position the remaining headband

on the crown of your head.

Conform the nosepiece across the

bridge of your nose by firmly

pressing down with your fingers.

Continue to adjust the respirator

and secure the edges until you feel

you have achieved a good facial fit.

Now, perform a Fit Check.

Instruction for use

Fit Testing

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Qualitative Fit Testing

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Qualitative Fit Testing

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1. OSHA Websites:

•Tuberculosis Information,

http://www.osha-slc.gov/SLTC/tuberculosis/index.html

• OSHA Standard 1910.134 Respiratory Protection

http://www.osha.gov/pls/oshaweb/owadisp.show_document?

p_table+STANDARDS&p_id+12716

• Health Care Information,

http://www.osha-slc.gov/SLTC/healthcarefacilities/index.html

2. CDC NIOSH Websites:

•Tuberculosis Information,

• http://www.cdc.gov/niosh/tb/

•Respirators: Your TB Defence

•http://www.cdc.gov/niosh/docs/video/tb.html

3. TB Respiratory Protection Program in Health Care Facilities

Administrator’s Guide,

•http://www.cdc.gov/niosh/99-143.html

4. Guidelines for Preventing the Transmission of Mycobacterium

Tuberculosis in Health Care Facilities, 1994,

•http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00035909.html

5. Core Curriculum on Tuberculosis, What the Clinician Should Know,

•http://www.cdc.gov/nchstp/tb/pubs/corecurr/default.html

Additional resources

The KIMBERLY-CLARK* ADVANTAGE:

It’s Essential

to Everything We Do.

Culture of Innovation

Supporting you in protecting your staff and patients

Knowledge Network* Clinical Education

Guidance on mask selection

In-service on fit testing

Training on masks donning and removal

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THANK YOU!

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Limpopo

North West Gauteng

Mpumalanga

KZN Free State

Northern Cape

Western Cape

Eastern Cape

South Africa:

28 M(X)DR Units

= ~2,500 Beds

MDR-TB units MDR-TB Units before 2009

Decentralized MDR-TB Units after 2009

The KIMBERLY-CLARK* ADVANTAGE:

It’s Essential

to Everything We Do.

Culture of Innovation

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Dr I H Master King George V Hospital Department of Health (KZN) iqbal.master@kznhealth.gov.za & Prof P Moodley University of KZN Infection Prevention and Control

A Special Thanks to All the Health Care workers who tirelessly continue the fight against TB and MDR TB often at great risk to themselves.

Thank You

Acknowledgements