Are You Always Ready for The Joint Commission or CMS Survey?

Are You Always Ready for The Joint Commission or CMS Survey? Sandy Garcia, RN, BSN, MBA Lead Consultant Certified Lean/Six Sigma Black Belt 1 Are You? Were You? Do You? Have You? 2 1

Infection Prevention and Control Does Your Staff Know the Contact Time of all Your PRODUCTS? Contact Time = Consider placing a large label on sani-cloths to indicate appropriate contact as outlined in the small print from the manufacturer. Contact Time= 3 Infection Prevention and Control Wire Cart Used for Supplies What Should You be Looking for? Solid Surface on Bottom Shelf! Outdates? 4 2

Medication Management Does Your Staff Have Access to Medications? Lidocaine 5 Medication Management Include authorization for these individuals to have access to medications in a policy. Consider placing into their job description. Consider a competency. Please email me for a sample policy and competency at sgarcia@jcrinc.com 6 3

Introduce the 2 nd generation tracer concept Utilize 2 nd generation tracers concepts for Cleaning, Disinfection and Sterilization within your organization 7 2 nd Generation Tracer Risk Process: CDC RN Emergency Surgery ICU I m a g i n g L a b C S MD MR 8 4

Cleaning, Disinfection and Sterilization 9 Perspectives July 2009 10 5

Let s Trace A Case Cart! Follow the case cart from an OR suite to decontamination. How are contaminated instruments contained during transport? If the organization does not have a case cart system, containment may be an issue. How are contaminated instruments transported in a timely manner? 11 Transport to Decontamination During transport to a decontamination area, are the instruments contained in a leak-proof container to minimize the risk of exposing personnel to contaminants during transport? How does the OR Technician or OR Nurse deliver the case cart to decontamination? Does he/she cross the line into decontamination? If so, is there appropriate PPE for him/her to change into prior to entering decontamination? 12 6

Central Processing Show me your AAMI standards? Are they readily available for all staff? Are they current? Show me the instructions on how you are going to clean, disinfect and sterilize this instrument (choose an instrument and see if they can locate the information manually or if they have a computer system, have them pull that instrument up and show you the information. 13 Central Processing Ask staff the contact time on all products used for cleaning. 14 7

Decontamination Upon entering decontamination... Does the staff in that area instruct you to put appropriate PPE on? Is the PPE available without you having to enter decontamination? Is there an Eyewash Station present? Is the eyewash station hooked up to tepid water (60-100 degrees F)? Note: If cold water only need to complete a risk assessment. How often does the staff check the eyewash station? Weekly per ANSI standards with a thorough maintenance check annually. 15 Eyewash Station Ask staff how many minutes they run the eyewash for during their check? 2-3 minutes per ANSI standards Are the eye pieces in place and good condition? Ask the staff to test the eyewash station. Is the pressure enough to push the eye pieces off? Sample Log Next Slide. Please email me for an electronic copy sgarcia@jcrinc.com 16 8

Sample Eye Wash Inspection Record Eye Wash Inspection Record 1. Eye washes must be tested and inspected weekly 2. Run the eye wash for 2-3 minutes 3. Ensure the water has sufficient water flow 4. Ensure the water is tepid (60 degrees F to 100 degrees F) and that there is sufficient water flow 5. Note whether the hands-free mechanism is functioning 6. Outlet heads (lids covering where water flows from) should be kept closed when not in use. These lids should pop off upon activation of the water 7. Initial the appropriate box below to document a passing inspection 8. If inspection fails, notify all users and call Plant Operations immediately at. Should an exposure occur, flush the affected eye(s) for 15 minutes. To ensure adequate flushing, hold eyelid(s) open and roll the eyeball Month/Year Week 1 Week 2 Week 3 Week 4 Supervisor/Manager Monthly Review: Note: Preventative Maintenance will occur annually to check for problems such as valve leakage, clogged openings and lines and adequacy of fluid volume (.4 gallons per minute for 15 consecutive minutes). These records will be kept within Plant Operations. 17 Decontamination Room Ask the staff if this room is positive or negative pressure? Perform a tissue test. Validate with requesting the readings from Engineering (these readings should be taken minimally yearly). How often is the room temperature and humidity checked? What are the appropriate temperature and humidity ranges for this room? Per AORN: Review logs to ensure negative pressure at least 10 air exchanges per hour (need to check minimally yearly check with state requirements, some are more strict than AORNs/AAMI guidelines). Temperature is maintained between 60 F and 65 F ( 20 C to 23 C). Humidity is maintained between 20% or 30% and 60% Review temperature and humidity logs recommend range thermometer in this area. Note: George Mills and TJC will now accept a 20% humidity-but CMS WILL NOT AT THIS TIME! 18 9

Ventilation (Table 7-1) Function Pressure Relationship Min Outdoor ACH Minimum Total ACH All Room Air Exhausted Directly Outdoors Relative Humidity Design Temp. F Equip. Room Negative N/R 10 Yes N/R N/R Soiled or Decontam Negative 2 6 Yes N/R 72 78 Clean Work Room Positive 2 4 N/R Max 60 72 78 Sterile Storage Positive 2 4 N/R Max 60 72 78 ANSI/ASHRAE/ASHE Standard 170-2008 Table 7-1 Decontamination Room Are doors kept closed in this room at all times? Is there a pass through window? Is this window kept closed when not in use? What supplies do you use and have available in decontamination? Minimally the decontamination area should be stocked with softbristle brushes, cleaning cloths, alcohol and appropriate PPE. Enzymatic cleaner is used for manual and automated cleaning of instruments. Alcohol is used to render instruments safe to handle after cleaning, if not rendered safe by another means. OSHA requires that personnel wear skin and mucous membrane protection (i.e. fluid-resistant or impervious gown, gloves and face protection). 20 10

Decontamination Room Manual Cleaning Process Which sink is used for soaking and which sink is used for rinsing? Are these labeled as such? Are instruments rinsed with cold running water before beginning the cleaning process? This will remove gross debris and help prevent coagulation of the blood present on the instruments. Some facilities use a spray. 21 Decontamination Room How much enzymatic cleaner is used per gallon of water? How do you know how much water is in this sink? How do you know how much enzymatic cleaner to use? Do you measure the cleaner when adding? Does the manufacturer of the cleaner require a temperature range of the water? If so, how do you ensure the temperature? Does the manufacturer require a soak? Do you time this process? 22 11

Decontamination Room Sonic Washers and Upright Washers What is the daily routine maintenance that is required on the sonic washer or upright washer? Review the manufacturer s guidelines. Who is responsible for the routine maintenance? If the answer is biomed, pull biomed records. Usually, biomed will do the PM s annually but will not do the other routine cleaning and maintenance. Does the organization have documentation supporting this routine cleaning and maintenance? 23 Sterile Processing Ask the staff if this room is positive or negative pressure? POSITIVE How often is the room temperature and humidity checked? What are the appropriate temperature and humidity ranges for this room? Review logs to ensure negative pressure at least 10 air exchanges per hour. Temperature is maintained between 68 F and 73 F ( 20 C to 23 C). Humidity is maintained between 20% or 30% and 60% Review temperature and humidity logs recommend range thermometer in this area. Note: George Mills and TJC will not accept a 20% humidity for any surgical service s area! 24 12

Ventilation (Table 7-1) Function Pressure Relationship Min Outdoor ACH Minimum Total ACH All Room Air Exhausted Directly Outdoors Relative Humidity Design Temp. F Equip. Room Negative N/R 10 Yes N/R N/R Soiled or Decontam Negative 2 6 Yes N/R 72 78 Clean Work Room Positive 2 4 N/R Max 60 72 78 Sterile Storage Positive 2 4 N/R Max 60 72 78 ANSI/ASHRAE/ASHE Standard 170-2008 Table 7-1 Sterile Processing Upright Washers Are you performing TOSI/VERIFY tests on your washers? How often? How did you determine the frequency? Show me the documentation. If not, how do you ensure that the instrumentation is clean after processing through your washers? How do you ensure that the proper temperature is reached during a wash cycle? 26 13

Sterile Processing Sterilizers, Sterrad What is the daily routine maintenance that is required on the sterilizer/sterrad? Review the manufacturer s guidelines. Who is responsible for the routine maintenance? If the answer is biomed, pull biomed records. Usually, biomed will do the PM s annually but will not do the other routine cleaning and maintenance. Does the organization have documentation supporting this routine cleaning and maintenance? 27 Sterile Processing Are alarms audible? How often are alarms checked? Note: If the department does not bring down (turn off) the steam sterilizers weekly, they usually won t meet the weekly requirements of the manufacturer. Quick question to ask and will give you a lot of information. Are biologicals documented per manufacturer? Does the documentation include expiration date and lot number? 28 14

Sterile Processing Environmental Cleaning How often is the sterile processing room terminally cleaned? Show me the policy. 29 Sterile Processing Storage of Sterile vs. Unsterile Where are unsterile items stored in the sterile processing room? Once the instruments come out of the sterilizer, what is the cool time and where do they go to cool? Is there a line that no one crosses with unsterile instrumentation? 30 15

Let s Trace Instruments from a Unit to Central! Where are instruments stored while awaiting transportation on the unit? If in the soiled utility room, is this room negative pressure-consider doing a tissue test. How are instruments held until pickup? If unit uses an enzymatic cleaner-refer to Central requirements in Decontamination. If they spray with a product and place in a biohazard container or place in water in a biohazard container, is it in their policy? Show me the policy? 31 Let s Trace Instruments from a Unit to Central! Watch transportation from the unit/s to Central. Are they transported in a container that will not leak? Recommendation: Drop container and see if lid comes off-don t do this with instruments in it! Make sure it is empty! Is the container clearly marked as biohazard? How is the container cleaned before bringing back to unit? 32 16

CIDEX OPA CIDEX OPA Is cidex OPA used in this area or any other area of the hospital (check respiratory, radiology, OB/GYN offices/clinics). How long is the cidex good for? (14 days) How long are the quality strips good for? When a new bottle of strips is opened, what is the process? Check QC under the attached instructions for the strips. Normally, a negative and positive needs to be conducted when a new bottle of strips are opened. A container of full-strength cidex and a container of half cidex and water needs to be prepared. Dip three test strips into each solution. Hold for 1 second and read after 75-90 seconds (check strips). Document the positive and negative controls before using that bottle of test strips. After a new bottle is open, how often do you retest the strips per hospital policy? SEE SAMPLE QC DOCUMENTATION TOOL NEXT SLIDE email me for an electronic copy-sgarcia@jcrinc.com 33 Sample Cidex OPA Daily Record Cidex OPA Daily Record (New record should be initiated with any change of solution, strip bottle or lot numbers) Cidex OPA Solution: Lot #: Date Opened: Exp. Date of Solution: Note: Unused Cidex OPA solution should be discarded 75 days after opening or by expiration date (whichever comes first). Cidex OPA Test Strips: Lot #: Date Opened: Exp. Date of Strips: Strip QC (Required when new bottle of test strips opened and PERIODICALLY AS DEFINED BY ORGANIZATION!! Positive Control (use with full strength solution - should pass): Pass Fail Negative Control (use half strength solution should fail): Pass Fail Note: Refer to QC instructions on insert attached to each bottle of strips. Discard test strips 90 days after opening or by expiration date on bottle (whichever comes first) or if QC of new bottle fails. Cidex OPA Solution must be tested prior to each use** with single test strip in actual soak solution. Change soak solution every 14 days or when it fails test strip test (whichever comes first) ** Solution Tested Date Item Pass Fail Time In/Initials Time Out/Initials Comments 34 17

QUESTION: One of my organizations heard that all areas where Cidex OPA is used requires negative pressure. However, OPA per their manufacturers guidelines do not require negative pressure. As you know, many organizations have to use OPA in their ultrasound areas for their probes since there is currently no alternative. This would make it very difficult when most organizations have the OPA in closed containers in their ultrasound rooms (risk assessment has been completed for access to the OPA by their patients). Please advise. Thank you. 35 ANSWER: Use of Cidex OPA or other disinfectants does not require the space they are used in to be maintained under negative pressure. The only cases, relative to the chemical itself, where the space would be maintained under pressure would be those instances when the hazardous vapors that are created get to a level where the health and safety of the workers is at risk. Using the chemical as you describe for ultrasound rooms typically does not pose that level of risk. Perhaps this comment was received relative to when Cidex OPA is used in a decontamination room, in which the room is required to be maintained under negative pressure to control the risks associated with cross contamination. George Mills, MBA, FASHE, CEM, CHFM, CHSP Director of Engineering 36 18

Example of Condition Level Deficiency IC.02.02.01 EP 2 482.42 - (A-0747) - 482.42 Condition of Participation: Condition of Participation: Infection Control This Condition is NOT MET as evidenced by: During tracer activity in the operating room it was noted the substerile room serving operating room three contained a flash sterilizer. This was one of two flash sterilizers contained in the operating room. The second flash sterilizer was not operable at the time of the tracer. (cont) Condition Level Deficiency (cont) The log book for the flash sterilizer near room 3 was reviewed during the tracer. This unit had been used to flash sterilize instruments needed urgently for active cases in the operating room. However, the chemical indicator strips that were used to monitor the performance of the sterilizer had expired for use in November 2008. 38 19

Condition Level Deficiency (cont) During tracer activity in the operating room staff indicated that the biological monitoring that was required for the flash sterilizer contained in the sub-sterile room of operating room three was performed and documented by the central sterile department. During tracer activity in the central sterile department the staff could not provide any documentation that biological monitoring had been performed for the flash sterilizer since 18 days prior to the tracer. (cont) Condition Level Deficiency (cont) The biological monitoring for all of the sterilizers in the central sterile department had performed and documented appropriately. Further investigator revealed that due to an apparent communication issue between the operating room and central sterile staff there had been no biological monitoring of the flash sterilizer since Jan 18, 2011. (cont) 40 20

Condition Level Deficiency (cont) During that time period instruments were processed in the flash sterilizer on January 25,26 and February 4, 2011. The minimum AAMI requirement for biological monitoring was noted to be once per week. Therefore this requirement had not been met. (cont). Condition Level Deficiency (cont) In addition, the hospital policy was to run a biological indicator daily each day a sterilizer was used. Prior to the end of the survey the hospital had re-qualified the sterilizer by running three consecutive biological indicators and had made changes to insure that the required biological monitoring would occur. 21

CMS Visits Supporting Partnership for Patients (PfP) As per the October 2011 letter, CMS is undertaking a wide range of actions to support the PfP goals. CMS Survey & Certification (S&C) program, together with our partners in the State Survey Agencies (SAs), also have important roles to play to promote optimum patient safety and quality of care. Our working assumption is that hospitals with full compliance with the Medicare CoPs pertaining to QAPI, infection control, and discharge planning requirements will be in a better position to reduce healthcare-acquired conditions (HACs) and the need for hospital readmissions. 43 CMS Visits (cont) To this end, CMS is pre-testing three new surveyor worksheets that are intended to aid surveyors in assessing hospital compliance with these three Medicare CoPs. The organization that recently experienced this survey was told they were selected based on their risk-adjusted all-cause readmission rates. Their initial letter presented by the surveyor stated they were being surveyed due to credible allegations of non-compliance. They were informed that no deficiencies would be cited unless they identify immediate jeopardy issues. 44 22

CMS Visits (cont) Subsequent communication with CMS revealed that they presume, as part of our pilot, that hospitals with poor readmission rates may be at greater risk for non-compliance with one or more of the three Conditions of Participation. We do recognize, however, that just being on the hospital list may not translate to non-compliance. Since this is a pilot we are promoting a collaborative, educational process as opposed to a more punitive approach. The focus of the survey is to assess compliance with the identified Condition of Participation, in your case Infection Control, and to test one of the three draft surveyor worksheets. 45 CMS Visits (cont) The 3-day survey focused on Infection Control compliance, as detailed on the surveyor worksheet included in the May 2012 letter. Issues of noncompliance with infection control CoPs were identified during the survey and shared with the organization. Noncompliance observations were not cited as deficiencies for the organization and will not require corrective action plans, as is usually the case during CMS surveys. 46 23

CMS Visits (cont) Examples of issues identified include observations of noncompliance with indwelling urinary catheter placement, central line dressing changes, isolation precautions, documentation of pressure relationships in negative/positive pressure rooms, and use of surgical attire (caps, masks). 47 PLEASE CONSIDER COMPLETING THE SELF ASSESSMENTS! S H A R E 48 24

Thank You 49 25