4 - l

SECTION 4 "BLOODBORNE STANDARD" EXPOSURE CONTROL PLAN


HAZARD DEFINITION

A toxic or hazardous s ubstance regulated under the OSHA standard(s) is any substance which bas the capacity to produce personal injury or illness to man thro ugh ingestion, inhalation, or absorption through any body surface.

BLOODBORNE PATHOGEN STANDARD

This standard was proposed in May 1989 and became effective in March 1992. The standard was developed in hope of reducing the amount of occupational related cases of Hepatitis B, HIV and other potentia1ly infectious diseases among health care workers. The standard covers over 20 infectiou s disease s. The facibty wi.11 follow a written ex posure control plan. The plan will be rev ie wed and upgraded annu ally. The law provides guidance by addressing the following areas:

• Developing an exposure control plan that ide ntifies all tasks and procedures where exposure may take place.

• Job classificatio ns - determining and documenting which employees are at risk (form for this

is found in the record kee ping section of this manual).

• Implemen ting - Universal and Standard Precautions, eng ineering controls. work practice controls and use of personal protective eq uip ment.

• HBV vaccine program

• Post-exposure evaluation and follow -up policies

• Infectious waste dis posal policies

• Use of biohazard labels and bags

• Housekeeping, decontamination and laundry practices

• Employee safety education and training

• Record keeping documents

The risk of exposure to potentially infectious body fluids should never be underestimated. Common fluids included are blood, blood products, semen, vagi11al secre tions, cerebrospinal fluid, sy novial fluid, pleural fluid, pe1itoneal fluid, pericardial fluid, amniotic fluid, saliva (in dental setting) and any other potentially infectious materials.


ELEMENTS OF THE EXPOSURE CONTROL PLAN

The following items are all part of the expos ure cont rol plan. T he following information is a review of the requirements and where to find or document these require ments.

Employer wiU identify tasks and procedure s where occupational exposure may occur.

IQ> Identify employee exposure determination by filling out the "Job Exposure Classification" form (page 8-4) found in the "Record Kee ping" sec tion of this manual.

Develop policies for job specific procedures and tasks that have an exposure risk. Polici es will be documented by the safety officer using the "Safety for Proced ures Performed" form found in this chapter (pg. 4-18) of the manual.

Offer the HBV vaccine (within lO working days of hire) and follow up blood test to confirm immunity status to employees in job classification 1 & 2. Employees will sign the "Hepatitis B Vaccination" form found in the "Record Keeping" section (page 8-7) of this manu al.

Take and document a comprehensive Safety Program (prior to job task assignment with potential exposure then annually) that covers the topic Listed in the "Safety Training" section of this manual.

Put in place the appropriate work practice controls, engi nee ring controls and use of personal protective equipment. General policies are listed on the " Work Practice and Engineeri ng Controls" pages found in thi s c hapter. Facility should add task specific policies. NOTE: If facility has not complied with ite ms applicable on these pages, the date of compliance should be noted ne xt to tJ1e item on lis t.

Biohazard labels and signs will be used to communicate hazards to em ployees . Guidelines and policies for biohazard lab eling is found in the "Labels" sec tion of this manual.

Personal Protective equipment will be s upplied, replaced and maintained by the employer in sizes that insure proper fit. General guidelines for what type and when to wear PPE is found in this cha pter. Job task s pecific PPE is Liste d in the individual "Safety for Procedures Performed" policies.


Housekeeping practices. facility cleaning and laundry practices will be documented and followed according to the schedule found in this chapter of the manual.

Medical waste will be disposed of as outlined in the chapter on medical waste and m accordance with OSHA and State law

All exposure incidents will be recorded as an injury. A "Post-Exposure" incident report form is found in the "Record Keeping" sect ion of this manual. Instructions on how to follow up a body fluid exposure are in tbis chapter (page 4-24 to 4-26). Employee medica l records are confidenti al. Injury records a.re to be kept for 30 years after the person leaves employmen t. The expos ure control plan will be reviewed and up graded as needed or annually. T his can be documented usi ng the form found on page l-3.


FACILITY EXPOSURE CONTROL PLAN CHECKLIST

Compliance Date: _ _ _ _ _ Facility Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

As of the above date the facility bas put in place the following policies to reduce exposure and contamination. Check all that apply to facility.

Universal/Standard Precautions are followed Work Practice Controls are in place

gloves are worn anytime contaminatio n is anticipated hand washing policies are followed

recapping, bending and breaking needles is prohibited all sharps are disposed of in biohazard sharps container all infectious waste is disposed of in red bags

eating, drinking, applying cosmetics, smoking is forbidden in work area Engineering controls are in place

hand washing facilities (sinks) are in patient care and laboratory areas antiseptic foams are available in areas that do not have a sink

Safety needles and devices used

mechanical pipettes are used (no mouth pipetting) eye wash sta tion is available

Personnel Protective Equipment

gloves are available (size appropriate, hypo-allergenic & liner (if needed) face protection is available (goggles, mask, full face shield)

clothing protection is available (gowns, lab coats) resuscitation equipment is available

Housekeeping

written schedule in place utility gloves available spill kit available

hospital grade disinfectant or 10% bleach is available laundry policies in place (if applicable)

Biohazard labe ls

on sharps containers and red bags

equipment that may be contaminated or hold biologicals laundry bins

Hepatitis B vaccine offered to all job classification 1 & 2 employees vaccine information docwnented

Policy to follow up an exposure is in place incident report forms in place

records are retained in a confidential manner Safety training provided

at time of employment annually

records retained 3 years


UNIVERSAL PRECAUTIONS/STANDARD PRECAUTIONS

POUCY : Employees will follow Uni versal and Standard Precautions at all times.

Both the Centers for Disease Control and The American Hospit al Association reco mme nd that ALL patient's blood and body fluids be handled as if infe ctious . U niv ersal precautions, as defined by the CDC, are a set of precautions designed to help prevent transmission of Hepatitis, the AIDS vir us (HIV) and other bloodborne pathogens. Body fluids listed und er uni vers al precautions are human blood and blood produc ts, se m en and vaginal secretions, pericardia!, peritoneal, pleural, amn jotic , sy novi al and cerebrospinal fluids, unfixed tissues and organs from humans (living or dead), saliva in dental procedure and any body fluid or clinical specimen co ntaining visible blood . Basic aseptic techniques must be use d to limit blood contact can prevent HBV, HCV and HIV trans miss io n in the health care setting. ln September 1997 the CDC pub!i.s hed new infection control guidelines and in troduced "S ta nd ard P reca utio ns". Standard precautions incorporate the major features of universal precautions bul added preca ution s for ALL body fluids, secretions and excre tio ns (except sweat), rega rdless of wbetber or not they contain vis ib le b.loo d (as stated in univers al precauti ons ). It also

i nclud es precautions for no n-inta ct s kin, muco us membranes, g uideline s for airborne diseases (<

Sum), droplet precauti o ns (> Sum) and contact precautions (e.g by hand contact).

Basic uni versal a nd stand ard preca utions include:

I.. Use barrier protection routinely to prevent skin and muco us membrane co ntami nat io n with blood or other body fluids.

2. Hands will always be washed before and after contact with patients. Hands will be washed even when gloves have been used . If hand s co me in contact with blood, body fluids or hum a n tissue, they will be immediately washed with soap and wate r.

3. GLOVES will be worn when contact with blood, body fluid. tissues and co nta minat ed s urfaces is anticipat ed .

4. GOWNS or plastic aprons are indicated if blood splatt e ri ng is likely.

5. MASKS and PROTECT IVE GOGGLES will be worn jf aeroso hzation or spla ttering are likel y to occur (e.g. certain dental and surg ical proced ures . wound ini gations, post­ mortem exa minat io ns and bronchoscopy).

6. To minimize the expos ure when perfo r ming emergency mouth-to-mouth res usci tation, mouth pieces, resuscitation bags, or other ventilati on devices will be strategical1y located and available for use in areas where resuscitatio n may occ ur.

continued next page


7. Sharp objects will be handled in such a manner to prevent accidental cuts or punctures. Used needles will not be bent. broken, reinserted into their original sheath or unnecessarily handled. T hey will be discarded intact immediately after use into an "sharps" needle disposal box which will be readily accessible (placed in all clinical areas, including patient rooms). All needle slick accidents, mucosaJ sp lashes or contamination of open wounds with blood or body fluids will be reported immediately.

8. Body fl uid spills will be cleaned up promptly with a hospital grade disinfectant solution or a 1: JO dilution of bleach.

9. All patients' blood speci mens will be considered biohazardous. Ail specime ns must be placed in plastic zip- lock bags for transport.

10. Linen so iled with blood or body fluids from ANY patient will be bagged and handled cautiously.

1 l . Non-disposable aiticles contaminated with blood or body fluids will be bagged and labeled using biohazard bags for decontamination and reprocessing.

12. Handle la boratory instrumen ts, especially need les and scalpel blades with extreme caution.

13. Use biological safety hoods for procedures that have a high potential for generating droplets.

14. Fill evacuation tu bes. vial. and bottles by using their internal vacuum only.

15. Use mechanical pipettes.

16 . Decontaminate work area and equi pment if co ntami nated with blood, other body fluids or potential dro ple t contamination.

17. Patient-Care equipment will be discai·ded or properly disinfected and/or sterilized.

* Additional policies are found throughout this chapter



PO LI CY :


SPECIAL PRECA UTI ONS FOR PHLEBOTOMY


./ All patient specimens will be handled as potentia lly infectious. Employees will always wear gloves - there are no exce ptions. No specimen will be consjdered a hi ghe r risk than another.

,/ When possible - blood w jll be collected using vacuum tube(s) rather than syringe to avoid unnecessary transferral of specimen.

,/ The employer and staff will determined by eval uatio n if the use of safety needles and/or safety holders will reduce number of need le stick inju1ies amo ng the staff. Based on thjs evaluation safety needles will be purchased and used . Trainin g will be provided on how to use.

Need les will not be bent, broken, recapped or removed from bolder unless tbe employer demonstrates that no a lte rnative is feasible..

,/ lf vac uu m tubes are fi lled from a syringe, use the internal vacuum only.

,/ To urni quets will be disposable or disinfected after use if visible soiled .

./ All spec im ens must be transported to the lab or stored in the lab will be placed in a seco ndar y co nta iner (eg. phlebotomy tray, test tube rack, plastic bag) to minimi ze accidental con taminatio n, s pillage or breakage. All secon dary co ntainers will be labeled with a biohazard label and disinfected regularly.

,/ On June 12, 2002 OSHA released a pos ition on the removal of contaminated needles from blood tube holders. The release stated (quote), "Removing contaminated needles and reusing blood tube holders can expose workers to multiple hazards. We (OSHA) want to make it very clear that this practice is prohibited in order to protect workers from being exposed to contaminated needles." (doc um e nt can be accessed on OSHA web sjte)


WORK PRACTICE CONTROLS

Work practice controls red uce the likelihood of exposure to pote ntia ll y infec tio us materiaJs by ensuring that procedures performed in the facility are performed using the safest technique possible. The fundamentaJ work practice control is Universal Pr eca uti o ns. T he healt h care worker must recognize the potential risks and make the decision of what necessa ry steps will be taken to maximize protection . Ri sks can be minimi ze d or eli mina ted by fo llow ing sim ple work practice rules.

POUCY: The following work practice con trols will be followed:

• Avoid hand-to-face contact while working

• Do not eat, d1ink, apply cos metics, handle contact le nses or smo ke in patient care areas

• Do not put food or drink s in lab refrigerators or f reeze rs

• Wash hands when gloves are removed

• Do not answe r phone or use com puter while wearing glo ves.

• Do not recap need les ( unl ess using "scoo ping techniques" or mechanicaJ means)

• Cover corks with gauze when opening vacutainers

• Never reac h into waste containers that might have contamin ated waste

• No mouth pipetting

• Decont amin ate work areas as needed

• Ask coug hi ng patients to wear a surgicaJ mask or turn their heads and use a tiss ue

• Let fa ll in g o bjects (e.g. needle, tube of blood) fall

• SLOW DOWN - most accidents happ en when you are rus hing!

ADD ADDITIONAL WORK PRACTICE CONTROLS SPECIFIC TO YOUR PR ACTICE HERE:





ENGINEERING CONTROLS


4- 10


An engineering control is a type of technology or device that isolates, removes or reduces the potential exposure hazard of a bloodbome pathogen. The combination of engineering and work practice controls are the recommended method of minimizing exposure to potentially infectiou s body fluids or materials. These methods are preferred because their effectiveness does not depend on the individual's decision of whether or not to use Lhem properly. These controls are exami.ned, evaluated, upg raded, maintained , or replaced on a regular schedule by the employer to ensure safety.

POLICY: The following Engineering Controls have been put in place :

./ Hand washing facilities near or in all work areas. If sink is not availa ble, antiseptic hand cleaner/towelettes will be available.

./ Sharps containers located in or near work areas where procedures are performed.

./ Leak proof storage containers for blood and body fluid specimens. (e.g. stoppered test tubes, zip-lock bags, test tube racks)

Red biohazard bags for disposal of all infectious (non-sharps) waste . The bag and receptacle will be marked with a biohazard sign.

./ Eye wash station (within 100 ft. or 10 sec. from area where exposure may occur)

./ SpilJ kit (for body fluid spills)

The following are additiona l engineering controls. Check the ones applicable to your faciJities safety policies. Add additio nal ones you may have purchased.

Safety and/or self-sheathing needles (document evaluation - pg.4-11 - 4-16) Centrifu ge has lid or tube s have caps

Mechanical/automated pipettes will be used in all laboratory procedures. Splash shield

Bio-safety hood

Secondary containers used for transport of needles or specimens Plastic capillary tubes


other _ _


_ _ _ _


_ _ _


_ _ _


_ _ _


_ _ _


_ _ _


4 - l l

ENGINEERING/WORK PRACTIC E CONTROLS SAFETY NEE DL E AND SAFETY DEVIC E EVALUAT IO N

POLICY: As part of our facilities compliance with OSHA's Bloodborne Pathoge n S ta ndard, the empl.oyer and/o r safety office r and em ployees will e valuate and ins ti tute e ngi neeii ng co ntrols that include safety needles and safety devices. The purpose of these contro ls will be to eliminating or minimizing employee exposure to potentially infectio ns disea ses . T he needles and devices selec ted will be appropriate to procedures being performed. The selectio n of safety needles and device s wi11 be based on a com binatio n of the facilities history of exposure incidents and the potential fo r exposure (if no such histo ry exists). The evaluatio n will be documented. Employee training on the use of contro ls se lec ted will be provided and documented. The safety need le program will be revie wed and revised annually to incl ude the addition of new tec hnologies that have been consider ed or put in place in the faci lity. AJJ sharps injuries will be documented in accordance with OSHA regulation s

Expla nation: The Bloodborne Pathogen S tand ard has always mandated the use of engineering controls (section d-2-I) and work practice controls to reduce or elimin a te e mployee exposure to bloodborne pathogens. Items s uc h as sharps containers, si nks to wash hands. eye wash station, s mechanical pipettes, splas h shields have always been accepte d as valu able eng ineer in g control s . Since the Bloodborne regulations were passes in 1991, many ne w safety technologie s have become availab le. Exam ples would be safe ty need les (e.g . se lf-sheathing need les & needleJess IV co nnectors) and plastic ca pillary tubes. The l 1/5/99 Bloodborne Pathoge n directive states (section D-2) that these new technologies must be co nsidered and requires the facilit y to evaluate exposure incide nts and determine if a safety device could have eliminated or reduced the chance of the accident from happening. On November 6, 2000 the Needles tick Safety Act (HR5 l 78) was signed into law by President Clinton. OSHA published the fmal rule in the January 18, 200 1 Fede ral Register. The new law became effective April 18, 200 1. Sim ply stated - if a safety needle or safety device will reduce, remove or isolate the hazard, the y m ust be use d.


The employer will invo lve the employees with the evalu ation and selection of approp1iate safety devices. Devices evaluated mus t be FDA cleared. Note that just because a device is FDA cleared it does not guarantee the device will be effective . Employees must still follow standard precautions, use work practice controls and wear personal protective equipment. Medical supply companies should carry a variety of safety needles and devices to evaluate. When eva luat ing safety need les and devices look for the following:

1. Safety feature provides a barrier between the ha nds and the need le af ter use. T he safety feature allows the workers band s to remain behind the needl e at alJ time s.

2. Th e safety feature is an integral part of the device and not an accessory.

3. The safe ty feature is in effect before disasse mbly and remain s in effect after disposal to protect users and trash handle rs.

4. The safety feature is as simple as possible, requiring little or no training to use.

1f tbe facility is inspected by OSHA, the compliance officer (OSHA inspector) will determine Lhrough interviews or observation of work whether sufficient engineering controls and work practic es are used. The compliance officer will review expo s ure incident reports. The compliance officer will determine if there were occasions where injuries occurred during the same procedure, us i ng the same equipment, in the same location or among simj}ar employees and determine whether engineering or work practices were implemented that could have prevented or minimized injuries . The com pliance officer will investigate if the employer has jnstituted alternative engineering controls in the areas where exposure injuri es have occurred. The employer will be cited for the failure to inve st iga te and implement engineering or work practice controls. If the facility is usi ng a safety device . but the compliance officer feels another device would be more effective, the compliance officer will document this and consult with the regional bloodborne pathogen coordinator to determine if a violation exists. The facilities investigation of safety need les and devices mus t be documented . The emp.loyer m ust docum e nt that em ployees were trained on the pro per operation and use of the safety needle and/or device. The compliance officer wil1 review the facilities investiga tion and determine if training was provided or lack of training resulted in the failure to use s uch controls.


Policy for pe1forming a safety needle evalua tio n:

1. The employer and/or safety officer will selec t products to be evaluated based on procedures performed and analysis of exposure injuries. Use form #1.

2. Evaluate three to four (or more) products. Products will be evaluated by individuals (employees) who will use the product. Document employees performing evaluation.

3. Instruc tio ns on use the safety device/needle and evaluations forms (form #2) will be provided.

4. Prod ucts will be tested in a sim ulated patient procedure (e.g. injection pads, oranges, training dummies).

5. Each evaluator will rate the system using question sheet provided.

6. Evaluator will ex press co nce rns that may not be covered on the evaluation fo1m.

7. T he employer or safety officer wil1 review the evaluations and document this review (form

#3).

8. The prod uct( s) that scored best will be purchased.

9. Training will be provided to employees that will use the product s and were not involved in the evaluat io n process .

10. The safety officer will annually evalu ate the safety needle and device program - purchasing new prod uc ts if ind icated.

DOCUMENTATION OF COMPLIANCE WITH THE SAFETY NEEDLE LAW


(date

_ (check if applicable)

ProErram was re-evaluated on:


Safety needle/device program was implemented

Safety needle/device program evaluated but not implemented. Reason is document on evaluation fonn #3 or document separate ly.

By (name)




) ) ) 4-14

ENGINEERING CONTROL EVALUATION FOR SAFETY NEEDLES (form #1)

Check: ( ) Initial investigation ( ) An nual review Date: Perso n performing review:

Procedure perfonn e d

w i th pot entia l risk

Average# performed per yea r

# of injuries reported per yea r

J o b t itl e(s) of exposed employee

Was the exp o sure preventab l e?

Ho w?

( u se additiona l space under co mm ents if needed)

Was a n e n g in ee rin g/wor k practice contro l impl emente d to prevent/reduce future ex po s ur es?

Ha ve inju ri es occurred

s inc e implementing control?

Injection

Phlebotomy using vaccutainer holder

Phle botomy using syrin e

Phle botomy using butterfly

Intravenous (IV)

Suturing

Scalpel (surgery)

Other:

Other:

COMMENTS:


Form(s) documenting evaluation of engineering control(s) follow this report.


Date: _ Product: Manufacturer:

Number of times used: Number of people participating in evaluation:

INSTRUCTIONS: Please circle the most appropriate answer for each question. Not applicable (N/A) may be used if the question does not apply to the product being evaluated.

Rate one to five; 1's good, S's bad, or not applicable (N/A).

I. The safety feature can be activated using a one-handed technique

1

2

3

4

5

NIA

2. The safety feature does noL inte rfere with normal use of the product

1

2

3

4

5

NIA

3 . Use of this product requires you to use the safety feature

I

2

3

4

5

NIA

4. T his product does no t require more time to use than a non-safe ty device

I

2

3

4

5

NIA

5. T he safety feature works well with a wide variety of band sizes

I

2

3

4

5

NIA

6. The de vice is easy to handle while wearing glo ves

]

2

3

4

5

NIA

7. This device offers a good view of any aspirated fluid

J

2

3

4

5

NIA

8. This device will. work with all required syringe and needle sizes

J

2

3

4

5

NIA

9. This device offers an alternative to rc-caooing

1

2

3

4

5

NIA

10. This product does not require more Lime to use than a non-safety device

I

2

3

4

5

NIA

ll. This product does not increase the number of sticks to tbe patient

I

2

3

4

5

NIA

12. There is a clear and unmistakab le change (audible or vis ible) tha t occurs whell I

2

3

4

5

NIA

the safety feature is activated

13. The safety feature operates reJiably

j

2

3

4

5

NIA

14. The exposed sharp is permanently blunted or covered after use and prior to disposal

1

2

3

4

5

NIA

15. This device is no more difficult to dispose of after use than a non-safety devic

e I

2

3

4

5

NIA

16. When using the device is not easy co skip a step needed for proper use

I

2

3

4

5

NIA

17. The user does not need extensive tra inin g for correct operalion

I

2

3

4

5

N/A

18.

I

2

3

4

5

NIA

19.

2

3

4

5

NIA

·

1

20 .

I

2

3

4

5

NIA

QUESTIONS Rate: 1 = agree t0 5 = d'1sa gree N/A

COMME NT or QUESTION..... _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _


Name of evaluator: Date Submitted:

Dat e : _ Produc t 1 : _ _ _ _ _ _ _ _ _ _ Manufacturer : _ _ _ _ _ _ _ _ _ Evaluatio n Fi nd i ngs:


_ _ _ _Product implemented ( ) yes ( ) no If yes, training given (date):


Report submitted by: _ _


_ _ _


_ _ _


_ _ _


_ _ _ _ _


Date: _ _


_ _ _ _



Date: _ _


_ _ _


Product 2: _ _


_ _ _


_ _ _


_ _ Manufacturer: _ _


_ _ _ _


_ _ _


Evaluation Findin gs:



Porduct implemented ( ) yes ( ) no If yes, training given (date): _

Report submitted by: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Date:



Date: _ _ _ _ _

Evaluatio n Findings:


Product 3: _ _ _ _ _ _ _ _ _ _ Manufacturer: _



Product implemented ( ) yes ( ) no If yes, training give n (date):


r-·.


Re po1t s ubmitted by: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _


Date: ____


SAFETY PROTOCOLS FOR PROCEDURES (STANDARD OPERATING & EXPOSURE CONTROL PROCEDURES)

Each medical facility has special safety procedures that are uniq ue to that particular practice. These procedures combine work practice controls, engineeiing contro ls, personal protective equipm ent, disinfecti ng procedures and medical waste. The fundame nta l procedure would be using uni versal precautions. Safety policies reduce the lik e liho od of exposure to hazards. Many times the iisks can be elimina ted by changing tbe way a procedure is performed. Make copies of the fo]Jo win2:S AFETY PROCEDURE FORM. Fill in the information for any procedure that involve s e xpos ure to potentially infectious body fluids . Do not limit these policies to only infection control - this form can be used for safety for other hazards such as chemicals and X-ray as well. Common examples are lis ted below. Check the ones you do and add to this list.


Acupunct ure Allergy Test in g

Aspiration of Breast Cyst Aspira tio n ( needle - ge ne ra l) Amnioce ntes is

Artifi cial In se minatio n B io psies

Bone Marrow Cast removal

Cleaning of suction machine Chemical peels

Chemotherapy (adminis tering) Circumcision

Colposcopy Cryosurgery Cystoscopy D & C

Debride ment

D ress ing change/wound care Electromyograp h

Endoscopy Endometrial Biopsy Finger or Heel Stick Freezing with nitrogen Hysteroscopy

Injections (not li ve vacci ne) Inoculation (live vacci ne) Intramuscular Injection s


fUD & Pessa ries I V Set Up

Lab Tests (p, e fo r ming) Laser

Laser for hair removal Leep

Lesion/Abscess Incision Lumbar puncture

Medical Waste (transpo tt in g) Myringotomy

Nuclear Stress Test Paracente sis

Removal of nasal packing Shaving of body hair Sigmo idoscopjes Spirometry

Staple removal

Surgical Procedures (major) Surgical Procedures (minor) S ut urin g

S utu re remova l Te rminations

T horace ntesis

Tr igger point injections

Vaginal exams (PAP and KOH ) Vasectomy

Venip uncture X-ray



Note: Policies above and additional policies are available from POC for $3.00 each. Call for list.


SAFETY FOR PROCEDURES PERFORMED


PROCEDURE:_ _ _ _ _ _ _ _ _ _ Type of Hazard:_ _ _ _ _ _ _ _ _ _


_ _ _

_ _ _


_ _ _

_ _ _


_ _ _

_ _ _


_ _ _

_ _ _


_ _ _

_ _ _


_ _ _

_ _ _


Person Performing Procedure: _


Person Assisting Procedure:_


_ _ _


_ _ _


_ _ _


_ _ _


_ _ _ _ _


_ _ _ _


_ _ _


Personal Protective Equipment Used:_ _


_ _ _


_ _ _


_ _ _ _


_ _ _ _ _


_ _ _ _



Proper Techniques for Safety:


What is done with used materials and soiled instruments?





What Chemical Products are Involved?


Additional Risks of Procedure?


Additional Comments:



Prepared By: _ _


_ _ _ _ _


_ _ _


_ _ _


_ _ _


_ _ _ Date: - - - - - - - - -


HAND WASHING

Most infectious agents found in the clinical facilities are spread by direct contact or respiratory exposure. Good hand washing and adhere nce to universal precautions will help break the chain of transmission and produce a safe work environment. The employer must provide adequate hand washing facilities. If a sink is not available in a patient care room, an anti-bacterial hand cleaner will be made available for immediate use until the employee can get to a nearby sink.

POLICY : During daily activities, your hands come in contact with many organisms and that can transmit infections. Frequent hand was hing is essential for both your protection and your patients. Hands will be washed:

• lf co ntaminated by blood, body fluids, or tissues.

• After every patient contact.

• After removal of gloves and other protective wear or equipment.

• Before leaving the clinical work areas.

• Before eating, drinking, smoking, applying makeup, or changing contact lenses outside of the lab, and after using lavatory facilities.

• Before all other activities that entai l hand contact with mucous memb ranes or a break in the skin.

• Periodically during the day when routinely handling and testing body fluids.

The wearing of tings and bracelets will be avoided because they might interfere wi th a thorough hand washing. They also make it more difficult to don gloves!

PROPER HAND WASHING PROCEDURE

l. Wet hands and apply a small amount of an antiseptic soap (3-5 mL).

2. Vigorously lather hands and rub toge ther for at least 15 seco nds.

3. Wash well between the fi ngers, und er nails and up the wrists.

4. Rinse well with a moderate su·eam of water in a downward motion.

5. Dry with a paper towel and use the towel to turn off the faucet. Dry skin adequately to avoid dermatitis.


Alcohol hand rinse or d isinfect ing foam products may also be use d for quick decontaminating the hand s whenever clean running water is not available. However. these products should not be used as a substitution for hand washing.

Frequent hand washing can be very damaging to the skin's normal protective mechanisms by damaging or cracking skin, alte1ing its PH, or changing its normal flora. Recent stud ies sugg est that frequent application of hand lotion may reduce this damage; medical personnel, therefore, are encouraged to use it. This may be difficuh , however, as one should avoid applying hand lotion immediately after washing, 1ight before giving direct patient care, or right before handling of sensit ive instruments or equipment. Lotions might interfere with the res idual action of the antimkrobial hand washing products.

GLOVE REMOVAL

Hands will always be washed following glove removal. Glo ves must be removed in a way that will avoid contamination of hands. Remove gloves when they become contaminated, damaged, between patients or before lea ving the work area.

• With both hands gloved, peel one glove off from top to bottom and hold it in the gloved hand.

• With the exposed hand, peel the second glove from the inside, tucking the first glove inside the second.

• Dispose of the entire bundle promptly.

• Wash your hands thoroughly.



PERSONAL PROTECTIVE EQUIPMENT (PPE)

Th e Emplo yer must detenni ne what personal protective equipment is needed fo r spec ific tasks pelfonned in facility and s uppl y the employee with all the necessary PPE (in app ropriate sizes) for the tasks the e mployee performs. Employees are required to use PPE whenever there is a potential for direct sk in conta c t with bloo d, hazar do us chemicals, a nd potentially infectious materials.

All personal protec ti ve equipm e nt s hall be removed immediate ly upon lea ving the work area or as soon as possibl e a nd place d in an appropriate laundry hamper or disposed of. The emp loye r i s res po ns ible for the launde1i ng, cleanin g and/or replacing of all PPE. lt is the employe rs respo nsibility to enforce and monitor the use of PPE

POLICY : All e mploy ees will use the PPE reco mmended by the e m ployer when performing procedures with potential conta minat io n.

GLOVES

Gloves are avai lab le in all pati e nt and tes ting areas of the facility. They are provided in sizes appropriate to the empl oyees band size. Hypoa11erge nic g lo ves wiU be provided or an alternative if latex sensiti vity is a problem.

POLICY: Gloves will be worn when:


.,,..-.


• touching la b ora to r y spec im ens and tissues

• to uching co ntam inat ed ite ms

• touching patient m uco us membranes or non-intac t ski n

• performing phlebotomy

• when performing any surgical or invasive procedures

• when pe1fonning laboratory tests

• situatio ns where hand contamin ation is possible

• finger o r hee l s tic ks are performed

• when handling co ntaminated laundry

• whe n ha ndling biohaz,u do us waste or waste containers

• when cleaning contaminated surfaces


• when cleaning up spills

• when the employee has breaks in the skin, including cuts, scratches, and cha pped bands GENERAL POLTClES:

• Glove s must be changed between patients.

• Gloves mus t be re mo ved before touching non-contaminated items, s uch as telephone s.

• Glove s (used) will be disposed of according to local , s tate or OSHA regulati ons.

• Gloves are not required by law to be use d when administering intramuscular or subcutaneo us inje ctio ns as long as bleeding the could result in hand contact with blood is not anticipated .

CLOTIDNG PROTECTION

Lab coats and clothing protection will be fluid repellent if there is a potential for splas hin g or s praying of blood or body tl uicls . Clothing protection will be fluid resis tant (.imp ervious) if the re is the potentia l of soaking of blood or body fluid s. La b coats worn while performing laboratory tests are to be worn only in the laboratory area. The type and characteristics of the la bcoat/apron/ s moc k will depend upon the task and the degree of exposure anticipated. In areas where chemical splashes are great an impervio us apron appropriate for the task sha ll be worn. Cloth la bcoats worn to protect clothing from day to day soiling or to l.ook professional. will only be use d in situation s where no contac t with body fl uids is expected.

• Lab coats or aprons m us t be worn and buttoned closed while p erformin g lab tests.

• Soiled lab coats and aprons may not be taken from the lab.

• Lab coats and clothing protection must be changed whene ver visib ly contaminated with blood or body fluids.

• Dis posa ble lab coats and clothing protection will be discarded in the biohazardous mate rials bag after use.

• Contaminated reusa ble Jab coats and clothing protection will be placed in the biohazardo us la und ry bag.

• Lab coats and cJothing cover will be fluid resistant and appropriate for the task involved.

• Open back or open toe s hoes may not be worn when performing procedures that may involve splas hing or s prayi ng of infectious materials.


MASKS, EYE PROTECTION, AND FACE SHIELDS

Masks and eye covering or a face shield will be worn durin g procedures that are like ly to produce splas hes, spray, sp la tter, droplets, or aerosols of blood or other potentially infectious material s . Contact lenses may not be worn without safety glasses when performing procedures with risk or when performing laboratory procedures with potential risk. Appropriate precautions mus t be applied and wearers alerted to potential hazards.

Goggles o r face shields are used wben performing the foilowing tasks in this facility:



Goggles and face shields will be cleaned after use and before storage. This facility uses the following me thod and product to clean goggles and face shields:



ACCIDENTAL NEEDLE STICKS & BODY FLUID EXPOSURE

POLICY: Health care workers will follow uni versal and standard precautions when handling blood and body fl uids . If an exposure occurs, it will be reported immediately and acted upon promptly by the safety officer or employer.

Exposure to blood and body fluids can be categorized as either percutaneo us inju1ies (skfo punctured by needle, scalpel, or other sharp object), mucous membrane splash (s plash in the mouth, nose, or conjunctiva), or by open-wo u nd con tact (fresh open abrasions, incisions, human bites , or lacerations). Exposures by any body fluid to any open site will be taken serio us ly. Appropriate frrst aid will be administered as soo n as possible. The incident will be reported to the safety office r or e mploye r. The incident will be documented. The incident report will include detailed information on the accident. A fonn to document the exposure injmy is found in the "Record Keeping" section of th.is manual. The employee will be sent to an appropriate facility for evalua tion - as soo n as possible after exposure.

Needle sticks account for 80% of all exposure inj urie s reported. The following policies will he]p prevent or reduce needle stick injuries:

./ Do not recap, remove, bend or break needles from disposable syrin ges . ff recapping is unavoida ble, use a scooping technique or mechanical device.

If syringes need to be taken to another area of the facilit y for disposal - place uncapped

syringes in a secondary, covered transpo1t co ntainer.

./ Discard used needles immediately after us by dropping needle down i nto sharps containe r - needle down.

./ Do not overfill, shake or bang s harp s containers.

./ If a needle starts to roll off a table or counter - DO NOT try to catch it. Let it fall to the floor and then pick it up.

Use safety needle s and safety devices .


EXPOSURE FOLLOW-UP POLICY

• Any direct exposure from needle stick or sharps: (J) make the inju ry bleed (optional) (2) immedia tely wash the area with antibac terial soap and flus hed with large quantities of water

(3) put antiseptjc (betadine, iodine) on site .

• Any splas h to the eyes or mucu s membranes: (I) flush with large amounts of water at the eye wash sta tion .

• Report the injury to the safety sup e rvi so r - imm ediately or as soon as possible. Fill out a n exposure incid ent form (found in record keeping section of this manual). This form contains information on route of exposure and circumstances und er which the exposure incident occurred .

• Arrange medica l evaluation and treatment with a qualified health care provider as soon as possible or within 2 hours (CDC recommendation).

• The so urce individual wiU be identified (if possible). T he so urce wil1 be asked to sign a consent. A consent form is found in the record keeping section of this manual. T he sources blood will be tested, at no cost to individual , for presence of HfV, HBV and HCV. Jf the

sta tus of the sources HfV, HBV and HCV is known, it need not be repeated unl ess so urc e is a high risk . If consent is not obtained, the employer s ha ll estab lish that lega lly required consent cannot be o btrunecl. Lf consent is not obtained the follow-up treats the so urc e as positive for HJV , HBV and HC V. Re s ults of the source individ uals test will be made availab le to the exposed emplo yee.

• The emp loyee will be counse led, infom1ed of applica ble laws and given a copy of lhe Bloodborne Pathoge n Standard as part of the follow-up .

• The employee will be provided information on the identity and infectious status of the source.

• The employee will be vaccinated for HBV if not already vaccinated. If lhe employee is a lready vaccinated, tbe employee will be checked for current immunity s tatu s.

• The employee will be asked to consent to having her/his blood co.lJec te d and tested for HIV, HBV (or antibody stat us) a nd HCV. Collect blood as soon as poss ibl e (ie. within 2 ho urs) after the exposure. If consent is given for collection but consent is not give n for testing, the blood will be preserved for at least 90 days. If the employee elects co have the blood tested


during this period, it wi11 be done as soon as feasible. The emp loyee has the right to refose blood collection and testing. If so, the employee will fill out the "Waiver of Exposure Evaluation" form found in the "Record Kee ping" section of this manual.

• If the results for HIV are sere-negative, the tesl will be repeated at 6 weeks, 12 weeks, 6 months and one year. The extent of the follow-up wil l be determined by the health care provider seeing the employee for the exposure. This information is confidential.

• The administration of post exposure prophylactic treatment will be determined and

recommended when medicaUy indicated by the health care professional seeing the exposed employee. If recommended it wi11 be started as soon as possible.

• The employee will be given instmctions on their responsibility for follow-up medical treatmen t/appointm ents and where tbey are to go to be evaluated.

• AU information relevant to the approp riate treatment, including vaccination status of the employee are to be provided by the employer to the evalua tor.

• A written opinion from the health care professional seeing the exposed employee will be provided to the employer and employee within 15 days. This opt io n will not contain confidential information on the employee.

• The employer will only be infonned of the employee' s Hepat itis status. that the employee kept appointments for exposure follow-up , the employee was informed of the results of evaluation and that the emplo yee has been told about any medical conditions res ulting from the exposure.

• ALL FINDINGS WILL REMA IN CONFIDENTIAL. An employee has a right to a private post-expos ure follow-up. They cannot be forced to have this follow-up provided by the employer.

• All record keeping will be maintained in a confidential manor by the employer.

• All tes ting and treatment is at no cost to the employee.

T he CDC ''Hotline'' phon e# is1-888-448-4911. Call thisnumber to getcurrentinformationon how to counsel and treat health care worker's exposed to bloodborne disease.


BODY FLUID SPILLS

POLICY: All body fluid spills will be handled as potenti ally i.nfectious mate rial. The appropriate procedure for decontaminating spills of blood, body fluid s, or infectio us mate rials will include:

w Wear heavy duty gloves. Do not remove any glass or other sharp objects with your hands.

Rig id cardboard and a dust pan may be use d to handle scoop up suc h o bjects.

Absorb the spilled material with disposable absorbent materials, such as paper towels or gauze pads.

Clean all visibly spilled mate rial, using a detergent o r d is inf ec ta nt.

w Flood the spill s ite, or wipe down the spill site with disposable towels soaked in disinfectant or 10 % bleach solution (made fresh dai ly).

Wipe off the spill site with a clean dry paper towel or ga uze pad. Alternately, the disinfec tant may be permitted to air dry. follow manufac turer' s recomme ndations.

Place contam ina ted gloves and paper towel s in a plastic biohaza rd bag and dispose according to medical waste polic y.

Wash bands appropriately.

Re place items use d in s pill kit so it will be ready to use ne xt time needed .


Not es :


Repor t lar ge s pill s to safety officer, laboratory director or employer before cleani ng up. Commercial s pi ll kits may be purchased, if desired.


Th e spill kit( s) for facilit y is found:



SAFETY FOR CARDIOPULMONARY RESUSCITATION (CPR)

Employees should be prepared for emergency situation s when mouth-to-m o uth resuscitation will possibly be nece ssa ry. It is wise for all people worki ng in the med ic a l field to take a Cardiop ulmonar y Resuscitat ion course. These courses are given at the YMCA. Red Cross and often at local hospitals and high sc hool s. Mouth- pieces, resusc itation bags or ot her ventilati o n device s will be avaiIable to the staff. Employees will be instructed on their use. The res uscitation devise wj][ be disinfected with 10% bleach or equ ivale nt after use or discarded. Disinfec tant s uc h as l 0 % bleach will be left on for a mi nimum of 1 minute befo re being wiped off with a clean absorbent mate rial.

Although there has been no documenta tion of transmiss ion of hepatitis B virus du1i ng mo uth -to

mouth resuscitati o n, theore tic ally there is ris k of sa liv ary transmiss ion of HIV. As an additional precaution. gloves will be worn to p re ve nt contact with blood or sali va in the patient's mouth or on the face. CPR is not an OSHA regul ation . If facility has an AED -call POC to order a supplement for AED's.

PO LICY : Res uscitat ion devices are readil y available and accessi ble to employees who can reasonably be expected to perfo rm res uscita tion.

Resuscita tio n devises are kept:

Copy of CPR training card will be put in e mployee file. Enter e mployees ce rtified in CPR or date

group was trained: date _

date _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ date _

date _

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ date _

date _


_ _ _ _


_ _ _


_ _ _


_ _ _


_ _ date _ _ _


da te _


_ _ _ _


_ _ _


_ _ _


_ _ _


_ _ date _ _ _


_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ date _

date _

./ Use additional notebook paper to document if more lines are needed.


FACILITY CLEANING POLICY

POLICY : T he employer will assure that all work areas exposed to potentially infectious materials are disinfected and decontaminated as needed throughout the work day. Decontaminating procedures will always be perf01med prior to the general cleaning done by the housekeeping service.

The method of decontamination will be based upon the location, type of surface to be clea ned , type of soil present, and tasks or procedures being p, e f onn e d in the area. The work site will be maintained in a clean and sa nitary condit ion as outl ined below:

l. All surfaces exposed to any body fluids in the exami ning/treatment room(s) and laboratory (if applicable) will be cleaned wilh an appropria te hospital grade disinfectant (EPA approved) at the end of each workday or as needed during the day. If 10 % bleach is used it will be made daily or made and discarded after use as needed.

2. Examinin g room floors and laboratory floors (if applicable) will be cleaned a minimum of bi-weekly with a disinfectant cleaner.

3. Centrifuges (if present) will be wiped off with disinfectant weekly or as needed.

4. Phones will be frequently wiped off with disinfectant.

5. Any body fluid spills or chemical spills will be cleaned up immediately us ing the guidelines found in this manual. Employees will be instructed on the use and location of spill kits.

6. Medical procedure eq uipme nt and/o r laboratory instruments that needs servicing will be decontaminated best as possible prior to having the service company make repairs. Se rvice people will be instructed to wear gloves while servicing.

7. Protective coverings s uc h as plastic wrap, aluminum foil, or im pervio usly-backed absorbent paper must be used to cover equipment and enviro nmen tal surfaces. Coverings will be removed and replaced as soon as feasible aner contamination.

8. Additional Cleaning Protocols specific to procedures performed in the facility such as cold disinfec ting and heat sterilization are fo und else where in lhis manual or have been writte n on the "Safety for Procedures Performed "fonn found in this chapter.

FACIU TY USES THE FOLLOWING PRODUCTS TO DISINFECT WORK AREAS:



FACILITY CLEANING SCHEDULE FOR _ _


_ _ _ (year)


4-30


POLICY : Facility will be cleaned/disinfected daily (days of operation). Initial each day performed.

DATE

JAN

FEB

MAR

APR

MAY

JUNE

JULY

AUG

SEPT

OCT

NOV

DEC

J

2

3

4

5

6

7

8

9

10

ll

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31


HOUSEKEEPING

EMPLOYER/EMPLOYEE POLICY: It is the employers responsibility to ensure that the facility is maintained and cleaned in a san ita ry manner. If any surfac e is contaminated during the day, it wi1l be cleaned and decontaminated immediately by the staff usi ng a "hos pitaJ grade" (EPA approved) disinfectant. Spill kits and protective covering wiJI be available to the staff. The staff will be instruc ted on how to decontaminate work areas and clean up spills (chemical and biohazard). These cleaning procedures will always be done BEFORE the housekeepi ng se rvice comes to clean.

HOUSEKEEPING SERVICE PO U CY: Housekeeping workers will be made aware that certain ,u-eas of the facility might be contami nated with potentially infectious materials. Ho usekee ping workers will wear aJI purpose ut ility gloves and protective clothing when cleaning these areas. Housekeeping workers will be instructed on where infectio us waste (biohazard bags and sharps containers) is found and where (if applicable) it is stored prior to pick up. The housekeeping service will use an appropriate level J disinfectant to routinely clean work surfaces and floors. An EPA approved le vel 2 disinfectant wj]l be used to clean operating rooms. Walls, blinds and curtains only need to cleaned if visible soiled.

CARPET CLEANING POLICY: If the faci lity has carpets, the carpets will be cleaned on a regular bases with a disinfectant or germicidal type rug clea ner. Carpets are not recommended for exam in in g rooms and la boratory areas.

POLICY FOR HOUSEKEEPING SERVICE:


This facility uses the following Cleaning Service: _ _


_ _ _


_ _ _


_ _ _


_ _ _ _ _ _ _ _



The Servjce cleans the facility (frequency): _ _ _ _


_ _ _


_ _ _


_ _ _


_ _ _ _ _


_ _ _



The Service has been ins tructed on disin fec ta nts to be used: The Service workers are aware of safety precautions:

The Service workers und erstand bio-hazard labels: The Service uses PPE when cleaning facility:

The Service .is a ware of areas they should not clean or touch


yes_no_ yes_no_ yes_no_ yes_ no _ yes_no_


COMMENTS:



New Housekeeping Service : _ _


_ _ _


_ _ _


_ _ _ _ _


_ _ _


Date : - - - - - - - -


New Hou s ekeeping Se r v ice : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _


Date: _


LAUNDRY

The Bloodbome Standard specifically adcb:esses laundry practices in the facility. POLICY: The employer will ensure the following:

l. Contaminated laundry will be bagged at the location where is was used.

2. Contaminated laundry will be placed and transported in bags that are labeled or color coded and will prevent liquid see page if s uch a potential ex ists. E mployees will be info rmed about the labeling system.

3. Laundry that is contaminated with blood or other potentially infe ctious materials wiU be treated as inf ectious, handled as little as possible and gloves worn while handling.

4. If a laundry service is used, the laundry workers will wear protective gloves to prevent exposure to potentially infectious mate1ials while sorting and handling.

5. If employees have contact with contaminated laundry they will wear protective gloves as well as any other appropriate personal protective equipment while handlin g it.

6. Handle soiled linen as little as possible and with a minimum of agitation to prevent gross microbial contamination of the air and of the persons handling the line n.

7. Linen s are to be washed with detergent in hot water of at least 71°C ( l 60°F) for 15 - 25 minutes. lf a lower temperature is used a chemical such as bleach must be added.

8. If lab coats, aprons or smocks are use d by employees as personal protective equipment, the employer shall provide for the cleaning and laundering. Personal protective equipment shall be removed prior to leaving the work area and placed in appropriately designated area or container, prior to washing.

9. Lab coats used only to look profession (not for protection) may be take n home by the employee to launder.

Home Launderirn::r :

Home la undering of contaminated PPE worn by employees is not permitted since the employer cannot guarantee that proper handling or laundering procedures are being followed. When not done correctly it may lead to the migration of the contaminants to the borne laundry.

If th e employee wishes to choose, wear and maintain his/ her own uniform or laboratory coat, then he/she would need to donadditional employer supplied PPE and employer controll.ed PPE when performing tas ks where it is rea so nable to anticipate exposure to blood or body fluids.


COMMENTS:_ _ _


_ _ _ _ _


_ _ _


_ _ _


_ _ _ _ _


_ _ _


_ _ _ _ _





LAUNDRY POLICY FOR FACILITY

Check here if facility uses all disposable linens for patients

C h e ck her e if only laundry sent out is physician or staff lab coats

LAUNDRY SERVICE POLICY: All so iled la undr y or linen will be handled as if potentially contam inated with body fluids.

All clean linen will be stored in an area where no soile d linen will come in contact with it. Clean linens are stored:

All soi led laundry or linen will be bagged at the site where it is used. It will be placed in a laund ry


bag Lhat can be identified as follows: _ _ _ _


_ _ _


_ _ _


_ _ _


_ _ _


_ _ _ _ _ _ _



Linen bags with so il e d laundr y are s tored: _ _ _ _


_ _ _


_ _ _


_ _ _


_ _ _


_ _ _ _ _


This facili ty uses the following laund ry service :


Laundry is picked up: _ _


_ _ _


_ _ _


_ _ _


_ _ _ _


_ _ _


_ _ _


_ _ _


_ _ _ _ _


Laundry service has been instructed on the handling of facility linen:


yes.


no _


date of instruction:

lf the facility does the laundry on site, the following laundry procedure is followed:


T he person designated to do the la und ry is:


PPE will be used by any person who handle s or launders soi led laundry .

If laundry service changes - write in new name and date below:

Date: Name:



STERILIZATION & DISINFECTI ON

Many agents are availab le to kill microorgani sms. You must choose the agent appropriate for the type of item or s urface it will be used on. It is the responsibility of the s taff to keep all work area's clean and disinfected throughout the workday . Disinfection and sterilization procedures should be used for all reusable instruments, devices and other ite ms that are contaminated with blood and/or other potentially infect ious materials (OPIM). Always follow the manufacturer's instructions.

A n tise pti cs are chemical germicides that are formulated to used on ski n or tiss ue. Antiseptics WILL NOT BE USED TO DECO NTAMJNATE INANIMATE OBJECTS OR SURFACES.

Di s i nfec t a nt s are agents that destroy or inact ivate specific viruses, bacteria, or fungi on inanimate s urfa ces . Disinfec tants come in three levels; low, intermediate and high. Select the appropriate le vel for the item(s) you are disinfecting . Check with the man ufac turer if you are unsure.

Level 1 - L ow : Appropiiate for non-critia l ca re items that have not been contaminated with blood or OPIM. Good for floors, counter tops, crutches, etc.

Level 2 - In t er media t e : To be use d to disinfect non-critical care items that have been contaminated with blood or OPIM. Good for potentially contaminated surfaces such as a phlebotomy chair or counter where blood tests are performed.

Level 3 - High : To be used for all semi-critical care items that could be damaged by heat sterilizati o n. T ime needed to soak these item can be found in the manufactu rer' s instructions for use. Semi-critical items would be instruments that touch mucous membranes but do not penetrate tissue. T his level would be cold steriliza tion so lut ions.

S te rili za tion: A process that destroy all viruses, bacteria, fungi and their spores. This would include instruments and/or devices that are introduced directly into the bloodstream or penetrate tissue. Ste riliza tion should be used on all critical care items that can withstand the steriliza tion process. Sterilizing me thods include use of steam under pressure (steam autoclave), gas, dry heat or chemicals under pressure (chemical autoclave).

Quali ty C on t r o l: SteriJization and level 3 disinfecting methods mus t be monitored for effectiveness. Controls are commercially available. Controls are a val uable way to determining whether or not the conclitions of the sterilizatio n have been achieved. Both chemical indicators (color indicator tape) and biological indicator s (s pore tests) will be used as recommended by the manu fa c turer.


TYPES OF DISINFECTANTS

Low Level (level 1): Household cleaners that the Environmental Protection Agency (EPA) makes no label claim for destroyin g tuberculocidal (TB) activity. These produc ts may be used for routine house keeping or soil removal on noncritical items such as floors, shelves and walls. Use according to the ins truction s on the label. Low level disinfecting is often call "sanitizing".

Product(s) use d:

Intermediate -l evel (level 2): Disinfectants the EPA terms as "hospital grade" and have been tested and shown to destroy TB, HBV or HIV. Intermediate level disinfectants will be used to decontaminate non critical items that have contact with blood and body fluids. A 1:10 bleach solution is recommended by OSHA. If 10% bleach is used it must be made fresh daily.

Product(s) used:

Product(s) used:

High-l e vel (level 3):

(1) Cold sterilization: High level disinfectants with glutaraldehyde that are used on reusable semi­ critical items that come in contact with potentially infectious body fluids. Items will be immersed an soaked according to the manufacturer's instructions. Control test strips will be used daily after 2 weeks to check effectiveness of disinfectants used for 28 days before disposal.

Product(s) used: Product(s) used:

(2) Heat Sterilization: Steam autoclave or dry heat autoclave.

Type used:

All reusable critical care items that can be sterilized - WILL b e ste riliz e d after disinfecting. Reminder: Make sure you have an SOS sheet for alJ level 2 and 3 di s inf ectants !


FACILITY DISINFECTION/STERILIZATION

Fill in this chart with items that are disinfected and/or sterilized

Item to be Disinfected

Product Used and Time

Items to be Ste rilized

Method and Time


COLD DISINFECTINGS/ TERILIZATION GUIDELINES

Sterilization is the total destruction of all living microorganisms including bacterial spores and viruses. The goal of sterilization is to render the i nstrument inert by destroying all pathogens. Cold sterili za tion is another term for im mersion sterilization. This entails soaking instruments in a fresh preparation of an E PA registered sporicide for the length of time specified by the manufacturer. Always follow the manu facturer ' s inst ructio ns!

STE RIL IZATI O N VS DI S I NFECTI N G

Sterilizin g des troys all microbial l ife on the article sterilized including hjg hJy resistant s pores. Disinfecting is less effective than sterilization s ince it de s troys viruses and some bacteria, but does not destroy spores. Cold dis infection will never be use d if an item can be sterilized.

LIABIL I TY

OSHA does not have regula tio ns on steriliza tion since OS HA's focus is on employee and not patient safety. The Center for Disease Control (CDC), the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) all hav e guidelines with general princ ipa ls for steriliza tion and disinfection. Although there are no routine inspections specifically for asepsis practices, failure to follow the guidel ines may render the ph ysician vulnerable to charges from patie nts. Every precaution taken to avoid a problem is prudent. The cost of one ma lpract ice s uit will be more that the cost of a lifetime of asepsis practice.

MATE RIA LS TO B E CO L D S T E R ILIZE D:

Se m i - C ritical It e m s: Items whic h come in contac t with mucosal memb rane, but do not normally penetrate body surfaces. Examples would be endou·acheaJ tubes, fiber optic scopes, amalgam carries, suture sc issors. A high level di si nfectant or sterilization to destroy vegetative bacterial is recommended.

Non- C riti ca l Item s: Tte ms which do not normally penetrate body surfaces or come in contact with muco sa] tiss ue. Examples would be bedpans, chairs, cr utches. Cleaning with a low-lev el disinfectant is adequate.


QUALITY CONTROL

The term "she lf life" and " use ful life" are use d to refer to the amount of time a cold sterilant may be used . The shelf- life is the amount of time a product is useful after it has been mixed or activated. The useful-life is the amount of time tl1e product wiU co ntinue to sterilize once it has begun to be used. Useful-life is difficult to determine. Most companies now market test strips which can determine whe n a cold ste rilant is no Lo nger useful for disinfecting or sterilization. If this mo ni tor is availab le it will be purchased and used daily after the product has been used for one week or as recommended by the manufacturer. Control tests can be documented on the quality control chart that follows.

ADVANTAGES AN D DISADVANTAGES O F COLD STERILIZATION:

Advantages :

Useful for heal sensiti ve items.

Disadvanta ges:

[terns cannot be packaged and cannot be stored sterile. There is no way to monitor in order to verify ste rility (test suips only monitor solution conce ntration). Chemical may a coITode metal instruments. Chemicals are diffic ult to hand le, may cause stainin g or irritation. Chemicals are relatively expensive. items must be rinsed thoroughly with sterile water (added cost) after removal from so lu tio n.

PROCEDURE:

Before cold steriliza tion items must be thoroughly cleaned and rinsed . IJ items are not cleaned p1ior to soaking, organic debris and blood may keep the sterilant from making contact with the item o r may hinder effectiveness of ste1i lant. After cold sterilizatio n, instruments will be rinsed and dried before storage. Follow manufacturers directions fo r product use.


SAFETY

When handling cold sterilizing so lut io ns, the fo llo wing preca utions will be taken:

I . Avoid skin co ntact. Always wear glo ves. Flush thoroughly with water if there js skin con tact. 2. A void eye co ntact. ln case of contact flush with wate r immed iately, and get medica l a ttention.

3. Harmful if swa llowed. Drink la rge quantities of water and call a physician. 4. Use in ventilated areas.

5. Do not use near food.

6. Have an S DS fo r all products used.

Refe re nces :

C DC. Sterilizatio n o r Disinfection of Medical Devices: Gene ra l Pr i nciples. 1998. CDC. Clea ning, Dis infect i ng, and Sterili z i ng P a tie nt-C are Equipm ent, 1998.

S paulding, C undy, Turner. "Che mica l Disin fec tio n of Medica l a nd Surgical Materials". 2nd. edition , Lea n & Fe bige r, Phil ade lphia, I977.

Crawford. "Clinica l Asepsis in Dentis tr y" . 3 rd. edition , Kols tad, Mesqui te, TX 1986 . Pelto n & Crane, Box 23 11 47, C harlo tte, N.C. 28224



GLOSSARY

Asepsis Freedom from infective microorga nis ms.

A utoclave A container for sterilizing by stea m und er press ure. Bioburden The le vel of organisms on a particular item at a spec ific time.

Biological Monitor A preparation of resis tant mi cro o rganis ms whic h is used to ve1ify ste rili za tio n. Usually require s incubation which may be perfo rmed by an independent laboratory. Also ca lled a spore test.

Cold Sterilant An agent which sterilizes at room temperature. Us ually a chemical suc h as glu tar aldehyde.

Disinfe ction De s truc tion of bacteria.

Draped Covered wit h a protective barrier.

Pathogen Any microorganism or virus that can cause disease.

Process Monitor An indicator which is se nsiti ve to at least one sterilization param ete r. Usef ul to indicate sterilization bypass buL does not ind icate ste rili zat io n. Examples: autocl ave tape, bea t-se nsitive bag markings, fusible glass meltin g pe lle ts.

S a niti ze To ma ke an ite m surgical ly clea n but not necessa rily ste rile. UsuaUy accomp lished usin g a low-l evel disinf ec tant.

Septic Uns teril e; ha ving infection caused by in trodu ction of patho genic mic roorgan is m whic h is highly resis tant.

S te riliza tion Total destruction of aH microbial li fe in c l uding bacteria, vim ses and spores.

Ultraso und A type of cleaner whic h uses ultra so ni c waves at high freq ue ncy to agitate co ntaminants and dirt from items.

Vegetative Bacteria A free ly m ultipl ying form of bactetia.


COLD STERILIZATION - QUALITY CONTROL

BRAND USED CONTROL USED

Date Made

Location of solution

Control Run (date)

Control Result

Date Discarded

Tech.

* USE TIDS CHART TO KEEP TRACK OF WHEN SOLUTIONS ARE MADE AND DISCARDED. START RUNNING CONTROLS AFTER 1 WEEK IF NOT DISCARDED.


STERILIZATION/AUTOCLAVE

Principle: The goal of sterili za tion is the total destruction of all living mic roo rga nisms includin g spo res and viruses. The U. S. Department of Health and Human Services states tha t "the adequacy of s terilization cycles wiIJ be verified by the periodic use of spore testing controls".

Ste rilization vs. Cold disinfecting: S terilizing destro ys all microbial life on the article sterilized incl udin g highly resistant s pores. Cold disinfec ting is less effect ive than ste1ilization si nce it destroys viruses and some bacteria, but does not destroy spores. Cold disinfec tion will ne ver be used if a n item can be sterilized.

Liability: OSHA does not have regulat io ns on ste ril iza tion since OSH A's focus is on employ ee and not patie nt safety. The Center for Disease Control (CDC), the Food and Drug Administration (FDA) and Enviro 1 me ntal Pro tec tion Agency (EPA) all have guidelines with general p rinc ipals for s teril iza tio n and dis infec tion. Althoug h there are no routine i ns pec tion s s pecifically for asepsis practices, failure to fo llow the guidelines may render the physic.ian vul nera ble to charges from patients. Every precaution taken to avoid a pro ble m is prudent. The cost of one malp ractice suit will be more that the cos t of a lifetim e of asepsis prac tice.

Ty p es of Sterilization: S team und er pre ss ure - autoclave, dry heat autoclave or oven and ethyle ne oxide gas.


MATERIALS TO BE STERILIZED

DEFINITION

EXAMPLE

DEGREE OF STERILIZATION REQUIRED

Cr itical Items

Any item which will enter the blood- stream or other normally intact and ste1i le areas of

t11e bo dy.

Surgical instrumen ts forceps, implants,

s urgical burs, handpiece s, scalpels

Abso lute sterilizat ion. Destroy all bacteria and spores.

Semi-Critical Items

Items which come in contact with mucosa} membr ane,

but do not norma lly penetrate

body surfaces.

Endotracheal tubes, fiber optic scopes, amalgam carriers.

High le vel dis infect io n o r sterilization to

des troy all vegetative bacteria.

Non-C ritical Items

Items which do not normally penetrate body s urfaces or come in contact with muco sa !

tissue.

Bedpans, crutches, chairs

Cle aning or low -level disin fection.


AVERAGE STERILIZATION TIMES - USING DIFFERENT METHODS:

AVERA GE STERILIZATION TIMES

Type Sterilizer

Instrument Packagin2

Temperature

Sterilizing Time

Estimated Tot.aJ Time

Steam* (a utoclave )

Loose

132C (270F)

121C (250F)

3 minutes

15 minutes

15-23 minutes

30-35 minULes

Wrapped

132C (270F)

15 minutes

30-35 minutes

121C (250F)

30 minutes

45 minute s

Packs

121C (250F)

30 minutes

45 mjnutes

Chemica l Vapor *

Loose

132C (270F)

20 minute s

23-28 minutes

Dry Heat*

NIA

I72C (340F) l60C (320F)

12IC (250F)

1 Hour

2 Hours

6 Hours+

l 1/2-2 1/2 hr 2 1/2-3 l/2 hr

6 1/2-8 hr

Cold Sterilants*

NIA

Ambient

7 - 12 Hrs

7-12 hours

*The above is a genera l guideline.

Different products require different times to achieve sterilization.

Refer to the manufacturer recommendations for recommended temperature s and times.

QUALITY CONTROL FOR PHYSICIAN OFFICE STERILIZATION. Tbe Center for Disease

Control recomm ends a steam sterilize r whenever possible. Indicator tape wiU be used on items being sterili ze d. While indicator tape is a use ful way to tell if an article has been through a sterilization cycle, it only indi cates the process and not if the item has been comp letely steriliz ed . Sterilization will be monitored periodically by use of a commercial spore testing preparation. Frequency of spore testing will be determined by frequency of autoclave use. Keep a!J s teri lizer maintenance and quality control documentation on the logs provided.

INTERPRETATION If indicator tape does not indicate proper sterilization has occun-ed - repea t process. ff it stilJ fails - refer to manufacturer manual for maintenance that can be performed or call manufacturer for service. If a spore test comes back and has failed, repeat test to verify, perform maintenance recommended by manufacturer or call the manufacturer for service.


4 - 45

ADVANTAGES AND DISADVANTAGES OF DIFFERENT STERILIZATION METHODS

T ypes of Sterilization Ad vantages Disad vantages

Steam

Econo mical. Good penetration of packs.

Uses moisture which may req uir e the

(autoclave)

Can be use d for stainless steel. textiles,

use of a s urgica l milk prio r to

liq uids, rubber goods. Short cycle time.

sterilizing high carbon content steel

Is easily monitored. Instrume nts may be

i nstruments. Packs sometimes retain

packaged prior to sterilization. Items

moisture if no t properly loaded or

need not be dried prior to placing in unit.

sterilizer is not properly maint ained.

No special chemicals o r ex haus t systems

required . T he sterilization method of

choice as specifi e d by the Associatio n of

Operating Room Nurses (AORN ) and

Centers for Disease Control (CDC).

Dry Heat

Rela tively low cos t unit. Can be

Difficult to control within narrow

(sterilizer)

monitored. Does not rust me tals. Can be

limits. Pene tratio n is slow and uneve n

used to sterilize anhydrous o ils and

so ex posure Lime mu st be relatively

powders.

Jo ng. Hi g h heat can damage some

metal sold e r joints. Canno t be use d for

plas tics, rubber, or textiles.

Cold

Useful for heat sensitive item s.

Items cann ot be packaged and ca nn o t

Sterilization

be sorted sterile. There is no way to

Liquid

monitor m o rder to verify sterility.

glutaraldehyde

(Test strips only may co ITo de metal

ins truments. Chemic als are difficul t to

ha nd le- m any ca us e starnrng o r

irrita tion. Che m ic als a re relative ly

ex pens ive. Items mus t be rinse d

thoroughly with ste rile water (add ed

cos t) after removal from so lu tio n.

Che m ica l

Relatively short cycle time. Limits rus t

Instrum ents mus t be dry. Special wraps

Vapor

o n high ca rbon metals. In s truments can

requir ed as chemical wiU no t penet rate

(chemiclave)

be packaged and monitored.

textiles reliably. Canno t be use d for

tex tiles, heav ier loa ds, or liquids. Must

use special chemical, increas ing the

c ost per cycle. Good ventilation

required almost chemicals used leave

an unpl eas ant odor.

PROCEDURE: Before s terilization all items mus t be thoroughly cleaned. [f they are not, organic debris and blood may keep the heal from making proper contact with the item, or in the case of cold sterilants, may hinder activity.


STEPS FOR STERILIZATION

STERILIZATION METHOD

STEAM AUTOCLAVE

ETO

DRY HEAT

CHEMICAL VAPOR

COLD STE RIL .

Thoroughly wash instrument s to remove gross debris (e ither mechanicall y or

us ing an ultraso nic cleaner)

Always

Alw ays

Always

Always

Always

Rinse insu·uments

Always

Always

Always

Always

Always

Dry instruments

Only necess ary if water bas

high chlo rine or mine ral level

Always

Always

Always

Always

Wrap instrume nts

Use steam permeab le material

Use gas perm.

mater.

See mfg. instr. for appropr.

wraos

See mfg. instr. for appropr. wraps

Not possible

Use process tape or bags with process

indicator

Always

Always

Always

Always

Not possible

Monitor weekly or as determined

Always

Always

Always

Always

Yes if available

Rinse instruments thorougWy after steriliz ation

No

No

No

No

Always

TH E ABOVE IS A GENERAL GUIDELINE . FOLLOW THE MANUFACTURER'S INSTR UCT IONS!



Pressure is important in autoclave ste rili za tion because the bacte1ia and spores are destroyed by heat which is transfen-ed from saturated steam . It is generally accepted that unw rapped articles may be sterilized by exposure to saturated steam at 132oC (27Qof)/186k.Pa (27PSI) for 3 minute s. If your ste rilizer has a pressure gauge, be sure to check the pressure as well as the temperature when recording quality control. The following is a general gu ideline - follow the manufacturer's instructions.

SATURATED STEAM TABLE

PRESS U RE

TEMPERATURE

PSI

k.Pa

oFa hr e nheit

oCe ntigr ade

15

17

19

21

23

25

27

30-32

103

ll 7

131

145

158

172

186

25QoF

254oF

257oF

260oF

264oF

267oF

27QoF

273oF

1210c

l 23oC 125oC

127oC

129oC

130oC

132oC

134o C

References:

CDC. Slerilization or Disinfection of Medical Devices: General Principles, 1998. CDC. Cleaning, Disinfecting, and Sterilizing Patient-Care Equipment, 1998.

Spaulding, Cundy, Turner. "Chemica l Disinfect ion of Medical and Surgical Materials". 2nd.

edition, Lean & Febiger, Philade lphia, 1977.

Crawford. ''Clinical Asepsis in Dentistry". 3rd. edition, Kolstad, Mesquite, TX 1986. Pelton & Crane , Box 231147, Charlotte, N.C. 28224


GLOSSARY


Asepsis Auto clave Bioburden Biological Monitor


Freedom from infective microorga nisms

A co ntainer for sterilizing by steam under pressure

The level or organisms on a particular item at a specific time

A preparation of resis tant microorganisms which is used to verify

sterilization.U sually requires incubat ion which may be performed by an indep ende nt laboratory. Also called a spore test.



Cold S te1ila nt

Di sinfe ctio n Draped Pathoge n

Process Monitor

Sanitize


An agent which sterilizes at room temperature. Usua lly a chemical such as g lut ar aJdehyde.

Destruc tion of bacteria

Cove red with a protective barrier

Any microorganis m or virus that can cause disease

An indicator which is sensi tive to at least one ste1i liza tio n parameter. Useful to indi cate ste rilization b ypass but does not indi ca te s teriliz at ion. E xamples : autocla ve tape, heat-sensit ive bag markings, fusible glass melting pellets.

To make an item s urgically clean but no t necess,uily sterile. Usua lly accomplished us in g a low -level dfainfec ta nt.


S e ptic Unsterile ; having infection caused by introduction of pathoge nic microorganism which is higWy resista nt

Sterilization Total destruction of all microbial life includin g bacteria, viruses and spores.

Ultrasound A type of cleaner which uses ult raso nic waves at high frequency to agitate contaminants and dirt from items

Vegetative Bac ter ia A freely multiplying form of bacteria


STERILIZATION MAINTENANCE AND QUALITY CONTROL LOG

DAILY/WEEKLY*

WEEKLY/AS NE EDED*

DATE

CHE C K SOLUTIONS

FJLL

RESERVOfR

(AS NEEDED)

CHEMICAL INDICATOR TA.PE

2500

TEMP.

C H ECK•

PRESSURE CHECK•

CLEAN EXTERIOR

CLEAN INTE RIOR

CRECK TI ME R

(

* Fo Uo wthe recommendationof the manufacturer. If autoclave printsoutfunction checks - keep printouts.



4 - 50

STERIL IZATIO N MAINTENANCE & QUALITY CONTROL LOG

SE R V I C E NEE D E D Q UALI TY C ON TR O L PR OBLEM D ATE A D JUSTMENT/ D ATE O F RESULTS

REPA IR S P ORE TE ST RECEIVED

* Keep all service and quality con trol s records with this chart.