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 2
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) 3
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)
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. 5
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) STD TB (intensive phase) STD TB (continuation phase) MDR (intensive phase) MDR (continuation phase) XDR (intensive phase) XDR (continuation phase) Cost (per patient per month) 2010 R67 R42 R1207 R968 R6654 R4263
Infection Control is the KEY 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 10
Fundamentals of Infection Control Administrative Controls Environmental Controls Respiratory Protection 1
12 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
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 13
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 14
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
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 16
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 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 17
NIOSH Standards Oil resistance Rating Description Not oil resistant Oil Resistant N95 N99 N100 R95 Filters at least 95% of airborne particles Filters at least 99% of airborne particles Filters at least 99.97% of airborne particles 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 P100 Filters at least 99% of airborne particles Filters at least 99.97% of airborne particles 18
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. 19 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
Approval holder s business name or manufacturers business name Filter designation: NIOSH filter series ie N95 TC# xxx-xxxx Approval number The name NIOSH or the logo Model # xxxx Lot # xxxxx 20
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% 21
All Kimberly-Clark Face Masks meet or significantly exceed the EN 14683 norm 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 KIMBERLY-CLARK* FLUIDSHIELD* 160mmHg LONCET* Polyethylene- Film NOTE: Type IR and IIR are splash resistant 22
23 So which respirator???
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 24
N 95 PFR Mask Construction of Kimberly-Clark face masks: 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. 25
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 26
Fluid Resistance A - INNER B - LONCET C - FILTER D - OUTER LONCET FILM Blood Air Air A B C D More blood resistant (160mmHg) Breathable (micro- perforated) Patented Film (false copies) 27
AIR OUT AIR IN BLOOD BLOOD 28
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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 30
Fit Testing Instruction for use 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.
Fit Testing Instruction for use Using your index fingers and thumbs, separate the two headbands.
Fit Testing Instruction for use While holding the headbands with your index fingers and thumbs, cup the respirator under your chin.
Fit Testing Instruction for use Pull the headbands up over your head.
Fit Testing Instruction for use Release the lower headband from your thumbs and position it at the base of your neck.
Fit Testing Instruction for use 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.
Qualitative Fit Testing 37
Qualitative Fit Testing 38
39 Additional resources 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
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 41
42 THANK YOU!
MDR-TB units 43 MDR-TB Units before 2009 Decentralized MDR-TB Units after 2009 North West Limpopo Gauteng Mpumalanga Northern Cape Free State KZN Western Cape Eastern Cape South Africa: 28 M(X)DR Units = ~2,500 Beds
The KIMBERLY-CLARK* ADVANTAGE: It s Essential to Everything We Do. Culture of Innovation
Acknowledgements 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 45