session name reprocessing complex surgical instruments...session name reprocessing complex surgical...

SESSION NAME Reprocessing Complex Surgical Instruments

SPEAKER Chuck Hughes

SESSION NUMBER 0004

DATE/TIME Sunday, March 30, 2014, 8-9am

REPEAT SESSIONS 0113, 0169

REPEAT DATE/TIME Sunday, March 30, 2014, 10:30-11:30am

Monday, March 31, 2014, 7-8am

CONTACT HOURS (CH) 1.0

SESSION OVERVIEW:

Complex instruments, such as orthopedic sets, endoscopes, and ophthalmic instruments, are reviewed with detailed examples of manufacturers' validated reprocessing instructions for use (IFU). Issues and solutions regarding securing manufacturers' IFUs, training, and educating personnel to comply, eliminating immediate-use steam sterilization (IUSS) and sterile storage of sterilized devices, will be discussed referencing AAMI Standards and AORN Standards and Recommended Practices for the reprocessing of reusable medical devices.

OBJECTIVES:

1. Identify where to find best practices for instrument reprocessing.

2. Discuss best practices for sterilization of surgical instruments.

3. Explain best practices for HLD of flexible endoscopes.

SPEAKER BIOGRAPHY:

Chuck Hughes is certified as a health education teacher who has worked over 25 years in the manufacturing industry in areas of research and development, regulatory affairs, microbiology, marketing, and sterilization training. A corporate member of AAMI, AORN, APIC, AST, CSA, IAHCSMM and SGNA, Chuck has extensive lecturing experience to medical device manufacturers and health care organizations around the world.

SPEAKER CONTACT INFORMATION:

Chuck Hughes

VP, Infection Prevention Consulting Services

Cantel Medical c/o SPS Medical Supply Corp

Rush, New York

[email protected]

FACULTY DISCLOSURE:

Chuck Hughes: 2. Cantel Medical Corp.

COMMERCIAL SUPPORT:

Gift-in-Kind: Cantel Medical Corp. (travel expenses)

mailto:[email protected]

Reprocessing Complex Instruments

1


Upon completion, participants will be able to...

1. Identify where to find best practices for instrument

reprocessing,

2. Explain best practice steps and common errors

associated with sterilization of surgical instruments,

3. Discuss best practice steps and common errors

associated with high-level disinfection of flexible

endoscopes.

Objectives

BEST PRACTICES Compliance is very important!

Best practices should be adhered to in any profession,

because they reflect the values of that profession. In

healthcare, adherence to sterilization and HLD best

practices ensures patient safety, as one of our greatest

threats is healthcare associated infections (HAIs).

In the U.S., it is estimated that 1/20 patients contact a

least one HAI during their hospital stay. That’s nearly

5,000 patients a day with over 300 deaths - each day!

Healthcare Associated Infections

While improperly reprocessed instruments is certainly

not the leading cause of healthcare acquired infections

(HAIs), it has been documented by the CDC and the

national media, as one of the causes.

We must do everything possible

to reduce HAIs, which means

compliance with best practices

not some of the time, not most

of the time, but all of the time!

In the U.S., hospital reprocessing “best practices” are

detailed in AAMI Standards, AORN Perioperative

Standards and Recommended Practices, along with

other documents, such as SGNA which focuses on

flexible gastrointestinal endoscopes.

Best Practices

Medical and dental office reprocessing “best practices”

are outlined in CDC Guidelines. The dental guidelines

are being updated this year and SPSmedical was asked

to participate in that process.

Best Practices


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All national survey organizations now audit healthcare

facilities for strict compliance with standards, guidelines,

and MFG’s instructions for use (IFU).

It is important to know…

The Centers for Medicare & Medicaid Services (CMS)

recently revised their Survey and Certification document

to include more stringent audits in the areas of infection

control and sterilization.

Areas of emphasis, include:

• Compliance with nationally recognized standards/documents.

• Formal training in areas of infection control and sterilization.

• Compliant cleaning, sterilization and monitoring procedures.

• Established criteria for flash sterilization.

Reference:

CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009.

AAAHC - The Accreditation Association for Ambulatory

Healthcare recently added an infection control chapter

to their standards handbook.

Infection control highlights included:

“Adhering to standards, guidelines, and manufacturer’s

instructions for cleaning, disinfection, and sterilization

of instruments, equipment, supplies, and implants.”

Reference:OR Manager Magazine, Volume 26, Number 2, 2010

July 20, 2011 - Joint Commission Online Focus on sterilization and high-level disinfection processes

Beginning in 2010, surveyors have spent additional time

during surveys evaluating the cleaning, disinfection and

sterilization processes.

In 2011, Joint Commission surveyors received in-depth

training on sterilization processes. This education was

provided in collaboration with AAMI and included a

review of all aspects of the AAMI ST79 guideline on

steam sterilization. Thereafter, a similar educational

module was delivered on HLD of endoscopes.

STERILIZATIONBest Practices

Point of Use

• pre-clean to prevent soil from drying during transport.

Reprocessing Area• clean & disinfect in Decontamination area,• inspect & assemble in Prep & Pack area,• package & sterilize in Sterilization area,• maintain sterility in Sterile Storage area.

Quality Assurance

• documentation & record keeping.

Common errors in the

reprocessing of Surgical instruments

Point of Use (Surgery)

• Failure to wipe off gross soil from instruments and

flush lumens with sterile water

• Delay in transporting soiled instruments to the

decontamination area

• Failure to spray instruments with pre-clean solution

• Transporting without using a closed container and/or

without a biohazard label


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sterilization of Surgical instruments

Reprocessing area (Decontamination)

• Not wearing proper PPE

• Not having enough sinks to soak-wash-rinse

• Not having sinks or an ultrasonic of sufficient size

• Testing some, but not all mechanical cleaners

• Not having MFG’s IFUs

• Not following MFG’s IFUs

Instructions For Use (IFU)

It is critical to follow the device

MFG’s instructions for use (IFU)

with regards to water temperature,

cleaning solution, brush type, and

cleaning procedures.

For complex devices, specific times

may be recommended for soaking,

ultrasonic washing and rinsing.

EXAMPLE - MFG’s Cleaning IFU

SYMMETRY Orthopedic Instruments

1. Submerge in enzymatic detergent.

2. Flush port with 50 ml enzymatic detergent.

3. Soak for 10 min in protein soluble detergent.

4. Scrub with soft bristled brush (agitate instrument

while scrubbing).

5. Rinse with warm tap water (38-49°C)

6. Flush port with 50 ml warm tap water.

7. Place in bath of warm water (agitate by hand for at least

1 min). Repeat this process 2 additional times.

8. Ultrasonic for 10 min with neutral pH detergent (flush

port with 50 ml prepared detergent before sonication).

9. Flush port with clean tap water (3 times).

10. Rinse for at least 1 min with tap water.

11. Dry with clean, lint free cloth.

12. Inspect.

13. Lubricate tip mechanism and finger slot (do not

lubricate flush port).


SYMMETRY Orthopedic Instruments

EXAMPLE MFG’s Cleaning IFUZimmer Orthopedic Surgical Instruments

1. Completely submerge instruments in enzyme

solution and allow to soak for 20 min.

2. Rinse in tap water for minimum of 3 min.

3. Ultrasonic clean for 10 min.

4. Rinse in purified water for at least 3 min.

5. Repeat sonication and rinse steps.

6. Remove excess moisture from the instrument with

a clean, absorbent and non-shedding wipe.

UPDATED – MFG’s Cleaning IFU

Jarit Endoscopic Instruments

Step 1. Maintain moisture:

Immediately after the surgical procedure, place the

instruments in an instrument tray/container and cover

with a towel moistened with sterile distilled water.

Foam, spray or gel products, specifically intended for

use with surgical instruments, are available to keep the

soil moist. Transport tray of soiled instruments in an

impervious plastic bag or container with a tight lid to the

decontamination environment (keep the outside of the

containment clean).


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Step 2. Enzymatic Soak:

Immerse fully opened and/or disassembled instruments

in an enzymatic solution, specific for use with surgical

instruments. Prepare the solution and use per enzyme

manufacturer’s recommendations, paying special

attention to instructions for correct dilution, temperature

and soak time. Flush air from lumens and fill them with

enzymatic solution for full contact with this inner

surface during the soak time.



Step 3. Rinse:

Remove from enzymatic soak after the time period

recommended by the enzymatic manufacturer and rinse

thoroughly with tap water. Flush lumens until rinse

water runs clear.

Step 4. Cleaning Instruments:

Choose a cleaning solution appropriate for surgical

instruments and follow the manufacturer’s instructions

for use.



The use of neutral pH detergents is vital to the

maintenance of surgical instruments. Contact with acidic

or alkaline solution will remove the instruments’

protective barrier of chromium oxide, often leading to

corrosion, pitting, and breakage. You may find that

depending on the type of soil, a detergent that is a little

more or less acid or alkaline may be more appropriate.

During manual cleaning, never use steel wool, wire

brushes, scalpel blades or highly abrasive detergent or

cleansers to remove soil from surgical instruments.



These will damage the instruments’ protective surface

and lead to corrosion. Use a clean soft bristled brush to

clean instruments with an accessible channel. Remove

the soil from the ratchets, jaws, tips, box locks, and/or

hinge mechanism. The ideal cleaning agent is

nonabrasive, low-foaming and free-rinsing. Using a

small clean hand-held brush, remove soil from all

surfaces of the instrument while fully immersed in the

solution. The box lock and hinge portion of an

instrument must be thoroughly cleaned after each use.



A build-up of soil, debris, lubricants, etc. in

these areas, will make it difficult to use the instrument

and eventually irreparably damage it. Vigorously flush

channels with the cleaning solution. Deionized water is

recommended and preferred because it is free of the

many compounds which exist in ordinary tap water.

These substances, alone, cause stains and when tap

water is combined with some detergents it will form

insoluble deposits on the instruments. Manual cleaning

should remove all visible residue. It is essential to keep

the box locks and hinges open during any manual or

automated cleaning process.



Step 5. Rinse:

Thoroughly rinse instruments by immersing in tap water

and wiping with a clean, soft cloth. Flush lumens until

water runs clear.

Step 6. Ultrasonic Cleaning and Rinsing:

Follow the recommendations of the ultrasonic

manufacturer regarding cycle times, detergents, proper

placement of the instrument tray, and conditioning

(“degassing”) of the cleaning solution, etc.


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Use an ultrasonic cleaner to remove soil from hard to

reach surfaces such as grooves, crevices, lumens,

instruments with moving parts, etc., after gross soil has

been removed. Open or disassemble instruments as

appropriate. Place instruments in a mesh bottom

stainless steel instrument tray. Place the tray into the

ultrasonic cleaner. Flush air out of lumens and fill them

with the ultrasonic cleaning solution (under the solution

level in the chamber) for effective removal of soil from

that inner surface by the ultrasonic activity.



Step 7. FINAL RINSE should be with “treated water”.

Softened or deionized water should be used for the final

rinse to better remove detergents etc. Softening water

removes calcium and magnesium ions that cause water

to be hard. Iron ions may also be removed by this

treatment. Deionization removes ionized salts and

particles from the water. Excessively hard water can spot

or stain instruments and excessive chlorine in water can

cause pitting of the instrument. Deionized water is

preferred for the final rinse.

Ophthalmic Instruments?

Improper cleaning of eye instruments can cause toxic

anterior segment syndrome (TASS). TASS is an acute

inflammation of the anterior chamber, or segment, of the

eye that usually starts within 24 hrs. of cataract surgery.

Patients with TASS complain of blurred vision, mild

ocular pain and eye redness. Left untreated, TASS can

result in permanent iris damage.


BAUSCH + LOMB StorzStorzStorzStorzOphthalmic Instruments

Bausch + Lomb is pleased to announce the availability of new cleaninginstructions for our surgical instruments marketed under the Storz Ophthalmic

Instrument and Bausch + Lomb Instrument brands.

Manual Cleaning

1. Disassemble the instrument as applicable and inspect the

instrument for damage or corrosion.

2. Pre-rinse the instrument by holding it under cold running water

for at least 30 seconds, rotating the instrument to expose all

surfaces and cavities to flowing water. Additional rinsing may be

necessary depending on the size and extent of soiling of the

instrument.

3. Place the instrument into a suitable clean basin filled with fresh

neutral pH cleaning solution prepared according to the directions

of the solution manufacturer. Use only cleaning solutions that are

labeled for use with medical devices or surgical instruments.

Ensure that the instrument is fully immersed in the cleaning

solution. The following conditions were validated using a neutral

pH detergent (Steris ProKlenz NpH) and a severe organic soil

challenge (Biomedical Instrumentation and Technology

2007;41(4):324-331).

4. Using a soft cleaning brush gently scrub all surfaces of the

instrument while keeping the instrument submerged in the

cleaning solution for at least 5 minutes. Clean the instrument until

all visible soil has been removed.

5. Rinse the instrument by holding it under cold running water for

at least 30 seconds, rotating the instrument to expose all surfaces

and cavities to flowing water. Additional rinsing may be

necessary depending on the size of the instrument and the amount

of soil.



6. Place the instrument in an ultrasonic bath filled with fresh

neutral pH cleaning solution and sonicate for 5 minutes. Use only

cleaning solutions that are labeled for use with medical devices or

surgical instruments. Ensure that the instrument is fully immersed

in the cleaning solution. Do not overload the ultrasonic bath or

allow instruments to contact one another during cleaning. Do not

process dissimilar metals in the same ultrasonic cleaning cycle.

7. WARNING: Do not process powered instruments in an

ultrasonic cleaner.

8. The cleaning solution should be changed before it becomes

visibly soiled. The ultrasonic bath should be drained and cleaned

each day it is in use or more frequently if visible soiling is

evident.




6

Follow the instructions of the manufacturer for the cleaning and

draining of the ultrasonic bath.

9. Repeat steps 4-6 as necessary if visible soil remains on the

instrument.

10. Rinse the instrument by holding it under warm (27˚C – 44˚C;

80˚F – 100˚F) running water for at least 30 seconds, rotating the

instrument to expose all surfaces and cavities to flowing water.

Additional rinsing may be necessary depending on the size of the

instrument.

11. If the instrument has lumens the lumens should be flushed

using a syringe filled with 50cc of warm distilled or deionized

water using a stopcock as follows:





a. Place syringe tip into a beaker of warm (30˚C – 40˚C/85˚F –

105˚F) distilled or deionized water and fill to the 50cc mark.

b. Connect the end of the syringe to the center stopcock fitting.

c. Rotate the stopcock lever to the male Luer fitting (irrigation) or

to the female Luer fitting (aspiration) to allow fluid flow to the

appropriate Luer fitting.

d. Connect the stopcock to the appropriate Luer connector on the

instrument.

e. Push on the syringe plunger to force fluid through the lumen

into another beaker for proper disposal. Do not draw flushing

fluid back through the lumen. Disconnect the syringe. Disconnect

the syringe/stopcock from the instrument.

f. Repeat steps A-E at least three times, for each lumen.

g. Fill the syringe with 50cc of air, reattach the stopcock, and

push on the plunger to force air through each lumen. Disconnect

the syringe/stopcock from the instrument.

NOTE: The CX7120 Universal Maintenance Kit contains a syringe and

stopcock suitable for cleaning instrument lumens.

12. Immerse the instrument in clean basin containing fresh

deionized or distilled water and soak for at least three minutes.

13. Immerse the instrument in second clean basin containing

fresh deionized or distilled water and soak for at least 3 minutes.

14. Perform a final rinse of the instrument with sterile distilled or

deionized water for at least 30 seconds, rotating the instrument to

expose all surfaces and cavities to flowing water.



Reprocessing area (Prep & Pack)

• Not inspecting 100% of instruments,

• Not using inspection lamps and/or lens,

• Cleaning instruments and/or rigid containers,

• Assembling hinged instruments in the closed position,

• Using improper materials (i.e. marking pens, sterilization

tape and/or wrap inside trays, sterilization tape on rigid

containers, peel pouches and/or count sheets inside trays).

• Improper location of lot control labels.



Sterilization

• Improper loading of sterilizers,

• Incorrect sterilization mode and/or parameters,

• Not enough dry time for type of load,

• Wet packs,

• Not allowing sterilized packs to cool to room temperature,

• Placing sterilized items to cool near AC vent.

If your facility reprocesses complex devices, then you

are probably dealing with “extended cycles”. As with

cleaning, it is important to know which and how many

of your devices require extended exposure time and/or

temperature settings.

STEAM Sterilization


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25 min @ 270°F (132°C) Pre-vacuum

Do not FLASH

complex instruments!

Medical devices sterilized by immediate use steam

sterilization (IUSS), formerly called flash sterilization,

can increase the patient’s risk for acquiring a surgical site

infection. As we have shown, complex instruments can

take 4 to 5 hours to reprocess when following the MFG’s

validated IFU.

Be sure to schedule your cases with enough time to fully comply (terminal sterilization) with reprocessing IFUs.

Tips to Eliminate IUSS

1. Update Policy & Procedures to reflect national standards.

2. Clearly define “emergency situation” that justify IUSS.

3. Educate all personnel as to risks associated with IUSS.

4. Review sterilizer logs to identify what is being IUSS. Review

each of these MFG’s IFUs to understand validated reprocessing

steps. Use this info to justify need for terminal sterilization.

5. Purchase additional instruments for back - back case schedules.

6. Adjust steam sterilizers to terminal cycles with dry time.

7. Hold all personnel (staff and vendors) accountable to comply

with Policy & Procedures.



Storage

• Placing sterile items in a high traffic area,

• Improper ceiling tiles and/or storage shelves,

• Dust on storage shelves,

• Stacking wrapped items on top of each other,

• Putting clean items on top of sterile items,

• Exceeding temperature and/or humidity ranges.

KimGuard® and One-Step® Wraps(Directions For Use)

Caution: Do not stack trays. Stacking trays can

result in damage of the wrap caused by undue

pressure from the

weight.

® Trademarks of Kimberly-Clark Corp.

Poor storage

Sterile processing personnel play a critical role in your

infection prevention efforts and therefore must receive

training and continuing education.

Failing to follow reprocessing

“best practices” can result in

infections, which causes harm

to patients and increased costs

to the health care facility.

Training & Education


8

AAMI Standards

Supervisors should..

• be certified,

• be experienced,

• participate in CE

programs and courses,

• provide in-service training,

• participate in Infection Prevention and

Safety committees (member or resource).

AAMI Standards

Technicians should..

• be certified,

• be competent in Standard

Precautions,

• be knowledgeable in

worker safety,

• be knowledgeable in all aspects of

sterilization and the operation of their

facility’s sterilizers.

Certification

IAHCSMM

International Association of

Healthcare Central Service

Materiel Managementwww.iahcsmm.org

Mission StatementProvide the members of the Association and healthcare facilities with organized educational opportunities, professional development, a forum for information exchange, member services in response to member identified needs and priorities,; and to represent Central Service Materiel Management in the professional community.

Certification

CBSPD

Certification Board for Sterile

Processing & Distribution www.sterileprocessing.org

Mission Statement

To promote and encourage high standards of ethical and professional

practice through a recognized, credible credentialing program that

encourages the competency of personnel performing sterile processing

and distribution activities.

Reprocessing Flexible Endoscopes

Flexible endoscopes are some of the most challenging

medical devices to reprocess due to their unique design

and complex reprocessing steps.

Again, strict adherence to each

device manufacturer’s validated

IFU is required.

Association of periOperative Registered Nurses

“Recommended Practices for Cleaning and Processing

Flexible Endoscopes and Endoscopic Accessories”.

Flexible endoscopes manufactured

by different companies may require

different cleaning procedures as

described in their MFG’s validated

IFU.


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SGNA Standards of Infection Control in Reprocessing of Flexible Gastrointestinal

Endoscopes

These updated (2012) Standards

are for use in all settings where

gastrointestinal endoscopy is

practiced.

They complement the 2009

SGNA document titled “Guideline

for the Use of High Level Disinfectants and Sterilants for

Reprocessing of Flexible Gastrointestinal Endoscopes”.

www.sgna.org

High Level Disinfection

Best Practices

Point of Use

• pre-clean to prevent soil from drying.

Reprocessing Area• perform leak test,• manual cleaning & rinsing,• high level disinfection (manual or automated),• rinsing, drying and storage.

Quality Assurance


Best Practices (Similar steps and similar “challenges”)

High-Level Disinfection

Point of Use


Reprocessing Area• perform leak test,• manual cleaning & rinsing,• high level disinfection (manual

or automated),• rinsing, drying and storage.

Quality Assurance


Sterilization

Point of Use


Reprocessing Area• clean & disinfect in Decontam,• inspect & assemble in Prep & Pack,• package & sterilize in Sterilization

area,• maintain sterility in Sterile Storage.

Quality Assurance



reprocessing of Flexible Endoscopes

Point of Use (Procedure Room)

• Not wearing proper PPE

• Not having MFG’s IFUs

• Reprocessing delay (multiple procedures and/or with

procedures performed at night or on the weekend)

• Failure to clean all channels (even if unused, fluid and

debris can enter channels at the distal tip)

• Transporting without using a closed container

and/or not labeled with biohazard id



Leak Testing

• Not having the MFG’s IFU available

• Use of damaged water resistant cap

• Overlooking pressurization of scope prior to

immersion

• Incomplete angulation of the distal tip in all

directions during leak test

• Not following the MFG’s IFUs for reprocessing a

damaged scope



Manual Cleaning

• Failure to fully submerge endoscope

• Failure to submerge for the required length of time

• Neglecting to dilute the detergent per the MFG’s IFU

• Using worn, damaged or improper brushes

• Failure to use MFG’s validated cleaning adapters

• Damaged/improperly reprocessed cleaning adapters

• Failure to thoroughly rinse


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Manual HLD

• Using a sink or basin of insufficient dimensions

• Using a solution after it’s expiration date

• Not MRC testing solution prior to

each use

AER

• Failure to manually clean and/or rinse before using

the Automated Endoscope Reprocessor (AER)



Storage

• Oversight in removing all valves

and water resistant cap when

storing the endoscope

• Neglecting to ensure that scopes

are hung with all locks in the free

position

• Crowded and unsecured scope

storage areas


Do you have enough resources?

Health care facilities must provide reprocessing personnel

with proper space, environmental controls, instruments,

equipment, water quality, supplies, training and TIME

to comply with MFG’s validated IFUs.

Conclusion

It is important to know that accreditation agencies are

now looking very closely at sterilization and HLD of

instruments when they survey your healthcare facility;

however, let’s not forget that your patients are looking

for strict compliance with reprocessing best practices

at all times.

I hope today’s program will assist you in achieving this

important goal!

Chuck Hughes

VP, Infection Prevention Consulting Services

Cantel Medical Corp. c/o SPSmedical Supply Corp.

6789 W. Henrietta Road · Rush, NY 14543 USA

(800) 722-1529 · E-mail: [email protected]

Certified as a Health Education teacher, Chuck has worked for over 25 years in the

manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology

and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA

and numerous other organizations, including AAMI and CSA where he contributes to

sterilization standards. A popular speaker at regional, national and international

healthcare conferences, Chuck has visited thousands of healthcare facilities during

his career providing sterilization consulting services that include fee based and

complementary audits of instrument reprocessing areas.

Thank You! References & Resources

Accreditation Association for Ambulatory Healthcare (AAAHC)5250 Old Orchard Road, Suite 200 · Skokie, IL 60077www.aaahc.org

Association for the Advancement of Medical Instrumentation (AAMI) 1110 North Glebe Road, Suite 220 · Arlington, VA 22201-4795www.aami.org

Association of periOperative Registered Nurses (AORN)2170 South Parker Road, Suite 300 · Denver, CO 80231-5711www.aorn.org

Centers for Medicare & Medicaid Services (CMS)7500 Security Boulevard · Baltimore, MD 21244www.cms.gov

Society of Gastroenterology Nurses and Associates, Inc. (SGNA)

330 N. Wabash Ave. Suite 2000 Chicago, IL 60611-5165 www.sgna.org

The Joint Commission (TJC)One Renaissance Boulevard · Oakbrook Terrace, IL 60181www.jointcommission.org

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